This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
(This note is not part of the Regulations)
These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to insert new post-market surveillance requirements. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 to implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Regulation 3 amends regulation 2 of the 2002 Regulations to update definitions that will apply for the purposes of new Part 4A.
Regulation 4 inserts a new part, Part 4A, into the 2002 Regulations. Part 4A contains new post-market surveillance requirements for medical devices and accessories to medical devices that are placed on the market or put into service in Great Britain.
New regulation 44ZE requires manufacturers to have a post-market surveillance system based on a post-market surveillance plan under new regulation 44ZF. New regulations 44ZG, 44ZJ and 44ZK set requirements in relation to preventive actions, corrective actions and field safety corrective actions. New regulations 44ZH and 44ZI, and 44ZL to 44ZP impose investigation and reporting requirements on manufacturers in relation to serious incidents, trends in incidents and the post-market surveillance of their devices generally. New regulation 44ZQ provides for the retention of the documentation produced by manufacturers under new Part 4A and new regulation 44ZR allows the time for providing requested information to be extended.
Regulation 5 amends Schedule 2A to the 2002 Regulations to remove the existing post-market surveillance requirements that are replaced by Part 4A. Regulation 6 makes provision to save those existing post-market surveillance requirements for devices placed on the market or put into service by their manufacturers before new Part 4A comes into force.
An impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector will be available from the Medicines and Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf, London, E14 4PU and published alongside this instrument at www.legislation.gov.uk.
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