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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

Type Regulation
Publication 2017-05-05
Last updated 2026-07-19
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 124
Reform history JSON API
  • 14.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.
  • 14.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
  • 14.5. Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
  • 14.6 Any measurement, monitoring or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.
  • 14.7. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.
    1. Devices with a diagnostic or measuring function
  • 15.1. Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods. The limits of accuracy shall be indicated by the manufacturer.
  • 15.2. The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC ([^E0012]).
    1. Protection against radiation

16.1.   General

  • (a) Devices shall be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation is reduced as far as possible, and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.
  • (b) The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.

16.2.   Intended radiation

  • (a) Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or non-ionizing radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.
  • (b) Where devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions.
  • 16.3. Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. Where possible and appropriate, methods shall be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.
  • 16.4. Ionising radiation
  • (a) Devices intended to emit ionizing radiation shall be designed and manufactured taking into account the requirements of the Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation.
  • (b) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.
  • (c) Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose whilst minimising radiation exposure of the patient and user.
  • (d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and, where appropriate, the quality of radiation.
    1. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
  • 17.1. Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance.
  • 17.2. For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.
  • 17.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).
  • 17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.
    1. Active devices and devices connected to them
  • 18.1. For non-implantable active devices, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.
  • 18.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical.
  • 18.3. Devices where the safety of the patient depends on an external power supply shall include an alarm system to signal any power failure.
  • 18.4. Devices intended to monitor one or more clinical parameters of a patient shall be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.
  • 18.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.
  • 18.6. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended.
  • 18.7. Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.
  • 18.8. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against unauthorised access that could hamper the device from functioning as intended.
    1. Particular requirements for active implantable devices
  • 19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:
  • (a) risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
  • (b) risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and
  • (c) risks which may arise where maintenance and calibration are impossible, including:
  • — excessive increase of leakage currents,
  • — ageing of the materials used,
  • — excess heat generated by the device,
  • — decreased accuracy of any measuring or control mechanism.
  • 19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure
  • — if applicable, the compatibility of the devices with the substances they are intended to administer, and
  • — the reliability of the source of energy.
  • 19.3. Active implantable devices and, if appropriate, their component parts shall be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.
  • 19.4. Active implantable devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.
    1. Protection against mechanical and thermal risks
  • 20.1. Devices shall be designed and manufactured in such a way as to protect patients and users against mechanical risks connected with, for example, resistance to movement, instability and moving parts.
  • 20.2. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.
  • 20.3. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.
  • 20.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks.
  • 20.5. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.

The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.

  • 20.6. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.
    1. Protection against the risks posed to the patient or user by devices supplying energy or substances
  • 21.1. Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user.
  • 21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source.
  • 21.3. The function of the controls and indicators shall be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.
    1. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons
  • 22.1. Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person's technique and environment. The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.
  • 22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to:
  • — ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information,
  • — reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and
  • — reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.
  • 22.3. Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:
  • — can verify that, at the time of use, the device will perform as intended by the manufacturer, and
  • — if applicable, is warned if the device has failed to provide a valid result.

CHAPTER III

REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE

23. Label and instructions for use
23.1.   General requirements regarding the information supplied by the manufacturer

Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:

  • (a) The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
  • (b) The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.
  • (c) Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.
  • (d) Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.
  • (e) Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.
  • (f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
  • (g) Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.
  • (h) Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.
23.2.   Information on the label

The label shall bear all of the following particulars:

  • (a) the name or trade name of the device;
  • (b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
  • (c) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
  • (d) if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;
  • (e) where applicable, an indication that the device contains or incorporates:
  • — a medicinal substance, including a human blood or plasma derivative, or
  • — tissues or cells, or their derivatives, of human origin, or
  • — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;
  • (f) where applicable, information labelled in accordance with Section 10.4.5.;
  • (g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;
  • (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VI;
  • (i) an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;
  • (j) where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;
  • (k) an indication of any special storage and/or handling condition that applies;
  • (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method;
  • (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;
  • (n) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union;
  • (o) if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;
  • (p) if the device is custom-made, the words ‘custom-made device’;
  • (q) an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;
  • (r) in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;
  • (s) for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
23.3.   Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)

The following particulars shall appear on the sterile packaging:

  • (a) an indication permitting the sterile packaging to be recognised as such,
  • (b) a declaration that the device is in a sterile condition,
  • (c) the method of sterilisation,
  • (d) the name and address of the manufacturer,
  • (e) a description of the device,
  • (f) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,
  • (g) if the device is custom-made, the words ‘custom-made device’,
  • (h) the month and year of manufacture,
  • (i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and
  • (j) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
23.4.   Information in the instructions for use

The instructions for use shall contain all of the following particulars:

  • (a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;
  • (b) the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;
  • (c) where applicable, a specification of the clinical benefits to be expected.
  • (d) where applicable, links to the summary of safety and clinical performance referred to in Article 32;
  • (e) the performance characteristics of the device;
  • (f) where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;
  • (g) any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;
  • (h) specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it;
  • (i) details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;
  • (j) any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons;
  • (k) the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
  • — details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection,
  • — identification of any consumable components and how to replace them,
  • — information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime, and
  • — methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices;
  • (l) if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
  • (m) if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;
  • (n) if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;
  • (o) an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements;
  • (p) if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request;
  • (q) for devices intended for use together with other devices and/or general purpose equipment:
  • — information to identify such devices or equipment, in order to obtain a safe combination, and/or
  • — information on any known restrictions to combinations of devices and equipment;
  • (r) if the device emits radiation for medical purposes:
  • — detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation,
  • — the means of protecting the patient, user, or other person from unintended radiation during use of the device;
  • (s) information that allows the user and/or patient to be informed of any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate:
  • — warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety,
  • — warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature,
  • — warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment,
  • — if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered,
  • — warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and
  • — precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user;
  • (t) in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra-indications, undesirable side-effects and risks relating to overdose;
  • (u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
  • (v) warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:
  • — infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and
  • — physical hazards such as from sharps. If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request;
  • (w) for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;
  • (x) for the devices covered by this Regulation pursuant to Article 1(2), information regarding the absence of a clinical benefit and the risks related to use of the device;
  • (y) date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use;
  • (z) a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;
  • (aa) information to be supplied to the patient with an implanted device in accordance with Article 18;
  • (ab) for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.

ANNEX II

TECHNICAL DOCUMENTATION

The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.

1. DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

1.1.   Device description and specification
  • (a) product or trade name and a general description of the device including its intended purpose and intended users;
  • (b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;
  • (c) the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;
  • (d) principles of operation of the device and its mode of action, scientifically demonstrated if necessary;
  • (e) the rationale for the qualification of the product as a device;
  • (f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;
  • (g) an explanation of any novel features;
  • (h) a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it;
  • (i) a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;
  • (j) a general description of the key functional elements, e.g. its parts/components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition. Where appropriate, this shall include labelled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts/components, including sufficient explanation to understand the drawings and diagrams;
  • (k) a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids;
  • (l) technical specifications, such as features, dimensions and performance attributes, of the device and any variants/configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.
1.2.   Reference to previous and similar generations of the device
  • (a) an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;
  • (b) an overview of identified similar devices available on the Union or international markets, where such devices exist.

2. INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

A complete set of:

  • — the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and
  • — the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.

3. DESIGN AND MANUFACTURING INFORMATION

  • (a) information to allow the design stages applied to the device to be understood;
  • (b) complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical documentation;
  • (c) identification of all sites, including suppliers and sub-contractors, where design and manufacturing activities are performed.

4. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

The documentation shall contain information for the demonstration of conformity with the general safety and performance requirements set out in Annex I that are applicable to the device taking into account its intended purpose, and shall include a justification, validation and verification of the solutions adopted to meet those requirements. The demonstration of conformity shall include:

  • (a) the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;
  • (b) the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;
  • (c) the harmonised standards, CS or other solutions applied; and
  • (d) the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, CS or other method applied to demonstrate conformity with the general safety and performance requirements. The information referred to under this point shall incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

5. BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT

The documentation shall contain information on:

  • (a) the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
  • (b) the solutions adopted and the results of the risk management referred to in Section 3 of Annex I.

6. PRODUCT VERIFICATION AND VALIDATION

The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements.

6.1.   Pre-clinical and clinical data
  • (a) results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;
  • (b) detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular:
  • — the biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user;
  • — physical, chemical and microbiological characterisation;
  • — electrical safety and electromagnetic compatibility;
  • — software verification and validation (describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer);
  • — stability, including shelf life; and
  • — performance and safety. Where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council ([^E0013]) shall be demonstrated. Where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision. An example of such a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service;
  • (c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;
  • (d) the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.
6.2.   Additional information required in specific cases
  • (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8), a statement indicating this fact. In this case, the documentation shall identify the source of that substance and contain the data of the tests conducted to assess its safety, quality and usefulness, taking account of the intended purpose of the device.
  • (b) Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is covered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or cells of human origin or their derivatives that have an action ancillary to that of the device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), a statement indicating this fact. In such a case, the documentation shall identify all materials of human or animal origin used and provide detailed information concerning the conformity with Sections 13.1. or 13.2., respectively, of Annex I.
  • (c) In the case of devices that are composed of substances or combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, detailed information, including test design, complete test or study protocols, methods of data analysis, and data summaries and test conclusions, regarding studies in relation to:
  • — absorption, distribution, metabolism and excretion;
  • — possible interactions of those substances, or of their products of metabolism in the human body, with other devices, medicinal products or other substances, considering the target population, and its associated medical conditions;
  • — local tolerance; and
  • — toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity, carcinogenicity and reproductive and developmental toxicity, as applicable depending on the level and nature of exposure to the device. In the absence of such studies, a justification shall be provided.
  • (d) In the case of devices containing CMR or endocrine-disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.
  • (e) In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with respect to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.
  • (f) In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.
  • (g) If the device is to be connected to other device(s) in order to operate as intended, a description of this combination/configuration including proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer.

ANNEX III

TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.

    1. The post-market surveillance plan drawn up in accordance with Article 84.

The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.

  • (a) The post-market surveillance plan shall address the collection and utilization of available information, in particular:
  • — information concerning serious incidents, including information from PSURs, and field safety corrective actions;
  • — records referring to non-serious incidents and data on any undesirable side-effects;
  • — information from trend reporting;
  • — relevant specialist or technical literature, databases and/or registers;
  • — information, including feedbacks and complaints, provided by users, distributors and importers; and
  • — publicly available information about similar medical devices.
  • (b) The post-market surveillance plan shall cover at least:
  • — a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
  • — effective and appropriate methods and processes to assess the collected data;
  • — suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;
  • — effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;
  • — methods and protocols to manage the incidents subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
  • — methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
  • — reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;
  • — systematic procedures to identify and initiate appropriate measures including corrective actions;
  • — effective tools to trace and identify devices for which corrective actions might be necessary; and
  • — a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.
    1. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.

ANNEX IV

EU DECLARATION OF CONFORMITY

The EU declaration of conformity shall contain all of the following information:

    1. Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in Article 31 of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of business where they can be contacted and their location be established;
    1. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
    1. The Basic UDI-DI as referred to in Part C of Annex VI;
    1. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information allowing identification and traceability may be provided by the Basic UDI-DI referred to in point 3;
    1. Risk class of the device in accordance with the rules set out in Annex VIII;
    1. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
    1. References to any CS used and in relation to which conformity is declared;
    1. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate or certificates issued;
    1. Where applicable, additional information;
    1. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication for, and on behalf of whom, that person signed, signature.

ANNEX V

CE MARKING OF CONFORMITY

  • 1.The CE marking shall consist of the initials ‘CE’ taking the following form:
  • 2.If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
  • 3.The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.

ANNEX VI

INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM

PART A

INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31

Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.

1. Information relating to the economic operator
  • 1.1. type of economic operator(manufacturer, authorised representative, or importer),
  • 1.2. name, address and contact details of the economic operator,
  • 1.3. where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,
  • 1.4. name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
2. Information relating to the device
  • 2.1. Basic UDI-DI,
  • 2.2. type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,
  • 2.3. Member State in which the device is to or has been placed on the market in the Union,
  • 2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
  • 2.5. risk class of the device,
  • 2.6. reprocessed single-use device (y/n),
  • 2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,
  • 2.8. presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance,
  • 2.9. presence of tissues or cells of human origin, or their derivatives (y/n),
  • 2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),
  • 2.11. where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations,
  • 2.12. in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose,
  • 2.13. in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person,
  • 2.14. in the case of class III or implantable devices, the summary of safety and clinical performance,
  • 2.15. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).

PART B

CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29

The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:

    1. quantity per package configuration,
    1. the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
    1. the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),
    1. if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),
    1. name and address of the manufacturer (as indicated on the label),
    1. the SRN issued in accordance with Article 31(2),
    1. if applicable, name and address of the authorised representative (as indicated on the label),
    1. the medical device nomenclature code as provided for in Article 26,
    1. risk class of the device,
    1. if applicable, name or trade name,
    1. if applicable, device model, reference, or catalogue number,
    1. if applicable, clinical size (including volume, length, gauge, diameter),
    1. additional product description (optional),
    1. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
    1. if applicable, additional trade names of the device,
    1. labelled as a single-use device (y/n),
    1. if applicable, the maximum number of reuses,
    1. device labelled sterile (y/n),
    1. need for sterilisation before use (y/n),
    1. containing latex (y/n),
    1. where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
    1. URL for additional information, such as electronic instructions for use (optional),
    1. if applicable, critical warnings or contra-indications,
    1. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).

PART C

THE UDI SYSTEM

1. Definitions
Automatic identification and data capture (‘AIDC’)

AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.

Basic UDI-DI

The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.

Unit of Use DI

The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.

Configurable device

A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.

Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).

Configuration

Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs.

Configurations include inter alia:

  • — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography.
  • — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.
UDI-DI

The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.

Human Readable Interpretation (‘HRI’)

HRI is a legible interpretation of the data characters encoded in the UDI carrier.

Packaging levels

Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case.

UDI-PI

The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.

The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

Radio Frequency Identification RFID

RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.

Shipping containers

A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems.

Unique Device Identifier (‘UDI’)

The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.

The word ‘Unique’ does not imply serialisation of individual production units.

UDI carrier

The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.

UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.

2. General requirements
  • 2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation.
  • 2.2. The manufacturer shall assign and maintain unique UDIs for its devices.
  • 2.3. Only the manufacturer may place the UDI on the device or its packaging.
  • 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used.
3. The UDI
  • 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.
  • 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
  • 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.
  • 3.4. The UDI-DI shall be unique at each level of device packaging.
  • 3.5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI.
  • 3.6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.
  • 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.
  • 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard.
  • 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
  • (a) name or trade name,
  • (b) device version or model,
  • (c) labelled as single use,
  • (d) packaged sterile,
  • (e) need for sterilization before use,
  • (f) quantity of devices provided in a package,
  • (g) critical warnings or contra-indications: e.g. containing latex or DEHP.
  • 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI.
4. UDI carrier
  • 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers.
  • 4.2. In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.
  • 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.
  • 4.4. For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.
  • 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable.
  • 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes. All parts and elements of the linear bar code shall be distinguishable and identifiable.
  • 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.
  • 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.
  • 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.
  • 4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances:
  • (a) any type of direct marking would interfere with the safety or performance of the device;
  • (b) the device cannot be directly marked because it is not technologically feasible.
  • 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.
  • 4.12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required.
  • 4.13. In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.
  • 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.
  • 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.
5. General principles of the UDI database
  • 5.1. The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.
  • 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.
  • 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.
  • 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.
  • 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
  • 5.6. The database shall allow for the linking of all the packaging levels of the device.
  • 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market.
  • 5.8. Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.
  • 5.9. Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.
  • 5.10. The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimized in order to reduce translations.
  • 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.
6. Rules for specific device types
  • 6.1. Implantable devices:
  • 6.1.1. Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);
  • 6.1.2. The UDI-PI shall have at least the following characteristics:
  • (a) the serial number for active implantable devices,
  • (b) the serial number or lot number for other implantable devices.
  • 6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.
  • 6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses
  • 6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.
  • 6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
  • 6.3. Systems and procedure packs as referred to in Article 22
  • 6.3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.
  • 6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.

Exemptions:

  • (a) individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;
  • (b) devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.
  • 6.3.3. Placement of the UDI carrier on systems or procedure packs
  • (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
  • (b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.
  • 6.4. Configurable devices:
  • 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.
  • 6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.
  • 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.
  • 6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.
  • 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.
  • 6.5. Device Software

6.5.1.   UDI assignment Criteria

The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.

The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.

  • 6.5.2. A new UDI-DI shall be required whenever there is a modification that changes:
  • (a) the original performance;
  • (b) the safety or the intended use of the software;
  • (c) interpretation of data.

Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

  • 6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI.

Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.

Minor software revisions shall be identified by a manufacturer-specific form of identification.

  • 6.5.4. UDI placement criteria for software
  • (a) where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;
  • (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen;
  • (c) software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);
  • (d) only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;
  • (e) the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.

ANNEX VII

REQUIREMENTS TO BE MET BY NOTIFIED BODIES

1. ORGANISATIONAL AND GENERAL REQUIREMENTS

  • 1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third country with which the Union has concluded an agreement in this respect. Its legal personality and status shall be fully documented. Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body.
  • 1.1.2. If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented. In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs.
  • 1.1.3. If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented. Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation.
  • 1.1.4. The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts.

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