LegalizeThe In Vitro Diagnostic Medical Devices Regulations 2000
Made: 11th May 2000
Laid before Parliament: 15th May 2000
Coming into force: 7th June 2000
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Citation and commencement
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Interpretation
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Scope of the Regulations
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Essential requirements for relevant devices
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CE marking
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CE marking of relevant devices that come within the scope of more than one Directive
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Relevant devices not ready for use
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Exemptions from regulations 4, 5 and 7
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Procedure for affixing a CE marking
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Supplemental provisions relating to conformity assessment procedures
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CE marking of a product which is not a relevant device
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Devices for performance evaluation
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Designation of authorised representatives for registration purposes
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Registration of manufacturers etc. of devices
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Designation etc. of notified bodies
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Functions of notified bodies
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Fees charged by UK notified bodies
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Enforcement etc.
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Notice procedures
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Transitional provisions
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Notification of decisions etc.
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Amendments to the 1994 Regulations
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Amendments to the 1995 Regulations
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SCHEDULE 1 — AMENDMENTS TO THE 1994 REGULATIONS
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SCHEDULE 2 — AMENDMENTS TO THE 1995 REGULATIONS
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Signed
Hunt — Parliamentary Under Secretary of State, — Department of Health — 6th May 2000
We consent,
Clive Betts — Bob Ainsworth — Two of the Lords Commissioners of Her Majesty’s Treasury — 11th May 2000
Explanatory note
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Footnotes
[^f00001]: 1972 c. 68.
[^f00002]: The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.
[^f00003]: 1973 c. 51.
[^f00004]: 1987 c. 43.
[^f00005]: S.I. 1994/3017.
[^f00006]: S.I. 1995/2487; amended by S.I. 1997/694.
[^f00007]: O.J. No. L331, 7.12.1998, p. 1.
[^f00008]: O.J. L204, 21.7.1998, p. 37; amended by Directive 98/48/EC (O.J. 217, 5.8.1998, p. 18).
[^f00009]: Council of Europe (ETS No. 164), Orviedo, 4.4.1997.
[^f00010]: As amended by regulation 23 of, and Schedule 2 to, these Regulations.
[^f00011]: See sections 11(1) and 45(1) of that Act.
[^f00012]: See section 45(1) of that Act.
[^f00013]: See section 11(7) of that Act.
[^f00014]: Amended by regulation 2 of S.I. 1997/694.
[^f00015]: O.J. No. L169, 12.7.1993, p. 1.
Editorial notes
[^key-62bca70dd72b92b3e9965cedb57822aa]: Regulations revoked (13.6.2002) by The Medical Devices Regulations 2002 (S.I. 2002/618), regs. 1, 66(f)
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