Explanatory note

These Regulations amend the Medical Devices Regulations 2002 (S.I.2002/618), as most recently amended by the Medical Devices (Amendment) Regulations 2008 (S.I.2008/375) (“the 2008 Regulations”). The 2008 Regulations implement Directive 2007/47/EC of the European Parliament and of the Council (OJ No.L.247, 21.09.2007, p.21).

These Regulations amend the 2002 Regulations to allow references to Council Directives 90/385/EEC (OJ No.L.313, 13/12/2000, p.22) and 93/42/EEC, (OJ No.L.6, 10.1.2002, p.50) to include amendments by Directive 2007/47/EC. These Regulations also contain a review provision whereby the Secretary of State must carry out a review of these amending Regulations every five years.

These Regulations also implement Commission Directive 2011/100/EU (OJ No.L.341, 22.12.2011, p.50), which amends Council Directive 98/79/EC (OJ No. L.331, 7/12/1998, p.1). The effect of this is to add to List A of Annex II of Council Directive 98/79/EC, variant Creutzfeldt-Jakob disease (vCJD) assays for blood screening, diagnosis and confirmation. This will ensure that notified bodies must verify conformity with the essential requirements of Annex I of that Directive.

These Regulations also amend references to Annexes 1 to 7 to Directive 90/385/EEC, Annexes I to X to Directive 93/42/EEC, and Annex I to X to Directive 98/79 (OJ No. L.331, 7.12.1998, p.1) by adding the words “as are amended from time to time”. The amendment is made in reliance on the powers in paragraph 1A of Schedule 2 to the European Communities Act 1972.

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk