Regulation of Medical Implants in the EU and UK: Fifth Report of Session 2012-13, [Vol. 1]: Report, Together with Formal Minutes, Oral and Written Evidence, Volume 1

Front Cover
EU regulations on the safety of medical implants-such as metal-on-metal hip replacements-must be urgently tightened in response to evidence that manufacturers are seeking approval for devices in Member States with the least stringent regulatory regimes. Much greater transparency is needed about the approval process so patients and doctors can have full confidence in the implants they are using. Manufacturers and regulators must also publish more rigorous clinical data on the safety of new implants and be subject to greater scrutiny. The clinical data requirements for high-risk medical devices to be sold on the European Market are much less stringent than for new medicines. There appears to be reliance on equivalence-similarity to an existing implant-rather than clinical investigations of the implant being approved. The Committee calls for all clinical data used in the approval of a medical implant to be published without identifying patients or clinical trial participants. For products currently on the market, such data should be published immediately. There should also be a public record of every approach from a manufacturer to any notified body in the EU so that 'forum shopping' can be identified. UK regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA) is criticised for its slow reaction to reports of problems with metal-on-metal hip replacements in Australia. The withdrawal of PIP breast implants also highlights the need for frequent and unannounced spot-checks of medical implant manufacturers to identify and prevent similar problems. The Committee is supportive of the proposed legislative changes from the European Commission to improve transparency
 

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Contents

Report
3
Premarket approval
12
Postmarket surveillance
27
Conclusions
39
Formal Minutes
47
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