Joint Committee on Statutory Instruments Twenty-Second Report


APPENDIX 4

Memorandum by the Department of Health

IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATIONS 2000 (S.I. 2000/1315)

  1. The Committee has requested a memorandum on the following point relating to the In Vitro Diagnostic Medical Devices Regulations 2000 ("the IVD Regulations").

    An enforcement notice as respects a device authorised to be served under regulation 19(1) must specify the relevant provision "of these Regulations", require the recipient of the notice to secure that the device conforms with the specified provision and may specify measures to be taken to secure compliance with the provisions of the Regulations. In the case of a relevant device within regulation 4, explain whether the provision to be specified in the enforcement notice will be regulation 4(1) [or (2)]"(ie the restriction on placing on the market) or the technical requirement (identifying it) in Annex I of the Directive. If it is the latter, explain how the specified Annex requirement falls within the quoted words of regulation 19(1).

  2. The point raised by the Committee also applies in relation to regulation 19(7) of the Medical Devices Regulations 1994 ("the MD Regulations"). Paragraph 8(2) of Schedule 1 to the IVD Regulations introduced a new paragraph (7) into regulation 19 of the MD Regulations, but the point raised by Committee would apply equally to the previous version of paragraph (7). It is envisaged that the practice the Department will adopt in relation to notices under regulation 19(1) of the IVD Regulations will mirror that adopted in relation to regulation 19(7) of the MD Regulations.

  3. The practice of the Department in relation to notices under regulation 19(7) of the MD Regulations has been to specify the relevant provision of the MD Regulations in the part of the notice that relates to regulation 19(7)(c) and then to identify, where applicable, the relevant Annex requirements in parenthesis afterwards. The Department considers that regulation 19(1)(c) of the IVD Regulations and regulation 19(7)(c) of the MD Regulations do not require specification of the relevant provision of the Annexes to the Directives.

  4. However, if the obligation to give reasons under regulation 19(1)(b) of the IVD Regulations or regulation 19(7)(b) of the MD Regulations is to be met, the Department considers that the notice will need to identify, where applicable, the relevant technical requirements in the Annexes to the Directives. In relation to regulation 19(7)(b) of the MD Regulations, the practice of the Department has been to specify the relevant provisions of the Regulations and, where applicable, the Directive in parenthesis at the end of the reasons given for breach of a particular requirement.

  5. Accordingly, were there a breach of regulation 4(1) of the IVD Regulations which related to the labelling particulars in Section 8.4 of Annex I to the Directive, any notice under regulation 19(1) would not, in the Department's view, need to contain reference to Section 8.4 in the part of the notice that related to regulation 19(1)(c) - although in practice it would contain such a reference in parenthesis - but would need to contain a reference to Section 8.4 in the part of the notice that related to regulation 19(1)(b).

  6. The Department intends to clarify the position in the near future by amending regulation 19(7)(c) of the MD Regulations and regulation 19(1)(c) of the IVD Regulations by adding at the end of the each sub-paragraph (c) the words "(and, where applicable, of the Directive)".

5th June 2000


 
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