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. )

CHAPTER I SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

The necessary common specifications shall be adopted by  26 May 2021. They shall apply as from six months after the date of their entry into force or from  26 May 2021, whichever is the latest.

Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products.

This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.

• (a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;

• (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;

• (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;

• (d) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;

• (e) cosmetic products covered by Regulation (EC) No 1223/2009;

• (f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable;

• (g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable;

• (h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;

• (i) food covered by Regulation (EC) No 178/2002.

However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council ([^E0001]), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.

However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned.

However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

• (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
• — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
• — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
• — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices:
• — devices for the control or support of conception;
• — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

• (2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

• (3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;

• (4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device;

• (5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended:
• — to be totally introduced into the human body, or
• — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;

• (6) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;

• (7) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

• (8) ‘single-use device’ means a device that is intended to be used on one individual during a single procedure;

• (9) ‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights;

• (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

• (11) ‘system’ means a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose;

• (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;

• (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

• (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken;

• (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;

• (16) ‘non-viable’ means having no potential for metabolism or multiplication;

• (17) ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues;

• (18) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials;

• (19) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries;

• (20) ‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;

• (21) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles;

• (22) ‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;

• (23) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm;

• (24) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;

• (25) ‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
• (a) perform without losing or compromising the ability to perform as intended, and/or
• (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
• (c) be used together without conflict/interference or adverse reaction.

• (26) ‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
• (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
• (b) communicate with each other, and/or
• (c) work together as intended.

• (27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

• (28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;

• (29) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose;

• (30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;

• (31) ‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;

• (32) ‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;

• (33) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

• (34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

• (35) ‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3);

• (36) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

• (37) ‘user’ means any healthcare professional or lay person who uses a device;

• (38) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;

• (39) ‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device;

• (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

• (41) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

• (42) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

• (43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

• (44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

• (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;

• (46) ‘investigational device’ means a device that is assessed in a clinical investigation;

• (47) ‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;

• (48) ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
• — clinical investigation(s) of the device concerned,
• — clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
• — reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
• — clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;

• (49) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation;

• (50) ‘subject’ means an individual who participates in a clinical investigation;

• (51) ‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

• (52) ‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;

• (53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

• (54) ‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site;

• (55) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;

• (56) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;

• (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

• (58) ‘serious adverse event’ means any adverse event that led to any of the following:
• (a) death,
• (b) serious deterioration in the health of the subject, that resulted in any of the following:
• (i) life-threatening illness or injury,
• (ii) permanent impairment of a body structure or a body function,
• (iii) hospitalisation or prolongation of patient hospitalisation,
• (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
• (v) chronic disease,
• (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

• (59) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer;

• (60) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

• (61) ‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

• (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;

• (63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market;

• (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;

• (65) ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following:
• (a) the death of a patient, user or other person,
• (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health,
• (c) a serious public health threat;

• (66) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

• (67) ‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;

• (68) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;

• (69) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;

• (70) ‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

• (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

Article 3

Amendment of certain definitions

The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level.

Article 4

Regulatory status of products

CHAPTER II MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT

Article 5

Placing on the market and putting into service

• (a) the devices are not transferred to another legal entity,

• (b) manufacture and use of the devices occur under appropriate quality management systems,

• (c) the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market,

• (d) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;

• (e) the health institution draws up a declaration which it shall make publicly available, including:
• (i) the name and address of the manufacturing health institution;
• (ii) the details necessary to identify the devices;
• (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor,

• (f) the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met;

• (g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and

• (h) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions.

This paragraph shall not apply to devices that are manufactured on an industrial scale.

Article 6

Distance sales

Article 7

Claims

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

• (a) ascribing functions and properties to the device which the device does not have;

• (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

• (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

• (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Article 8

Use of harmonised standards

The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).

References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.

Article 9

Common specifications

Article 10

General obligations of manufacturers

The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III.

Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof.

A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available.

The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

The quality management system shall address at least the following aspects:

• (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

• (b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;

• (c) responsibility of the management;

• (d) resource management, including selection and control of suppliers and sub-contractors;

• (e) risk management as set out in in Section 3 of Annex I;

• (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;

• (g) product realisation, including planning, design, development, production and service provision;

• (h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;

• (i) setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;

• (j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;

• (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

• (l) management of corrective and preventive actions and verification of their effectiveness;

• (m) processes for monitoring and measurement of output, data analysis and product improvement.

Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken.

If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.

If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.

The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.

Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

Article 10a

Obligations in case of interruption or discontinuation of supply of certain devices

The information referred to in the first subparagraph shall, other than in exceptional circumstances, be provided at least 6 months before the anticipated interruption or discontinuation. The manufacturer shall specify the reasons for the interruption or discontinuation in the information provided to the competent authority.

Article 11

Authorised representative

The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:

• (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

• (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);

• (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;

• (d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;

• (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;

• (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

• (g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

• (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

Article 12

Change of authorised representative

The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects:

• (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;

• (b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;

• (c) the transfer of documents, including confidentiality aspects and property rights;

• (d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.

Article 13

General obligations of importers

• (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

• (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;

• (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;

• (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.

Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.

Article 14

General obligations of distributors

• (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;

• (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);

• (c) for imported devices, the importer has complied with the requirements set out in Article 13(3);

• (d) that, where applicable, a UDI has been assigned by the manufacturer.

In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.

Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.

Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.

Article 15

Person responsible for regulatory compliance

• (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

• (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

• (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

• (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

• (c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

• (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

• (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

• (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

• (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Article 16

Cases in which obligations of manufacturers apply to importers, distributors or other persons

• (a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;

• (b) changes the intended purpose of a device already placed on the market or put into service;

• (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.

• (a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State;

• (b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.

Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.