EU medical device laws to undergo revision
BRUSSELS, Belgium: The European Commission has announced a revision of the legislation governing medical devices in the EU dating from the 1990s. According to the European consumer organisation BEUC, the plans will affect a wide range of products.
To date, medical devices in the EU have not been subject to any premarket approval by a regulatory authority but to a conformity assessment that involves an independent third party known as a notified body. The 80 notified bodies are monitored by the 27 member states. Once certified, devices bear the CE marking.
Recently, the existing directives have seen harsh criticism owing to the worldwide breast implants scandal caused by French manufacturer Poly Implant Prothèse. Earlier this year, it was found that the company had used industrial silicone instead of medical grade silicone for its breast implants, contrary to the approval issued by the notified body, according to the European Commission.
With the revision, the authorities aim to eradicate the flaws and gaps in the EU legislation, increase consumer protection, reduce risk and avoid costly recalls, said Monique Goyens, Director-General of BEUC.
The proposal includes stricter control of manufacturers and extends the definition of medical devices to include more products within the scope of the legislation. Moreover, it recommends closer monitoring of the notified bodies. A scrutiny panel is to be established for this purpose in order to assess medical devices according to certain risk-based criteria. Overall, the proposal is aimed at better product traceability.
“High-risk devices, such as implants, need much more thorough controls before being put on the market. Consumers must be given more and better information on medical devices while having the back-up of redress if things go wrong,” Goyens added.
Eucomed, a medical technology industry association that represents 22,500 European designers, manufacturers and suppliers of medical technology, however, has raised some concerns about the proposal. Although the organisation welcomes stricter control and monitoring, it believes that the measures would ultimately lead to a move towards a centralised premarket authorisation system, similar to the system found in the US, which would affect European small and medium-sized companies negatively, Eucomed stated. With a centralised premarket system, patients would have to wait three to five years longer on average for the release of a device, according to the association.
Before the regulations can be introduced, the proposal has to be approved jointly by the European Parliament and the Council of the European Union, which represents the governments of the member states.