Regulations on the safety of medical implants need to be tightened “urgently”, according to the House of Commons Science and Technology Committee.
A committee report, published 1 November, calls for manufacturers and regulators to publish “more rigorous” clinical data on the safety of new implants.
The recommendation was made following evidence that manufacturers of implants, such as metal-on-metal hip replacements, sought approval for their products in EU member states with the least stringent regulatory regimes.
“We were shocked to hear about [this] practice of so-called ‘forum shopping’,” said the chairman of the committee, Labour MP Andrew Miller. “Much greater transparency is needed about the approval process,” he added.
According to the committee, the approval process is too reliant on similarities to existing implants rather than new clinical investigations, and clinical data requirements for high-risk medical devices are less stringent than for new medicines.
The committee said it is “unimpressed” with the reliance on equivalence data. It noted that the EU is undergoing its own review of the situation, and praised the Commission’s proposed measures to make clearer what clinical information is required to make equivalence data acceptable. It also added its support to the Commission’s plan to enforce unannounced audits of manufacturers, and said this should occur at least annually.
However, the MPs did not agree with the proposal that manufacturers producing new implants should formally notify a central EU authority, deeming that this “increased bureaucracy could slow the approval process unnecessarily”. The report approves the plan to register all implants on the EU market centrally.
The MPs criticised the Medicines and Healthcare products Regulatory Agency for its response to reports of problems with metal-on-metal hip replacements in Australia, saying it showed “complacency in not recognising failings in the system”. Miller said the EU and UK must react more quickly to information about adverse incidents abroad.
All clinical data used during the approval of an implant should be published anonymously, and if the products are already on the market, the data should be made public immediately, the report said. It added that any approach a manufacturer makes should be a matter of public record, to identify ‘forum shopping’.