Oct 23, 2013
The European Parliament has voted in favor of implementing stricter requirements for Notified Bodies, but not for recommended medical device registration reforms that would create an approval process similar to Premarket Approval in the US.
Proposals for more centralized control of the European medical device market, made by the European Commission’s Environment, Public Health and Food Safety Committee (ENVI) last month, drew swift opposition from industry groups such as Eucomed. The proposals would create more difficult CE Mark certification and medical device registration processes particularly for small and medium-sized manufacturers, Eucomed argued, and MEPs seemed to agree.
Rules the European Parliament did approve include:
The heavy lifting is not over, though: The new rules must be reviewed and approved by EU member states, where industry concerns about burdensome regulations will come up against national governments eager to minimize the risk of another PIP breast implant scandal happening.
The European Commission has published an unofficial version of its new regulatory requirements for Notified Bodies that play a key role in CE Mark certification for medical devices.
Although the published requirements contain no reference numbers or dates, the document likely provides a clear indication of how Notified Bodies will have to comply.
Results from a recent survey by European medical technology trade group Eucomed suggest that medical device companies operating in the European Union may face compliance cost increases of up to € 17.5 billion through 2020 depending on whether a centralized premarket authorization system proposed as part of Medical Devices Directives revisions (draft Regulation) becomes law.