Expert: Don’t Expect EU Final Regs Before May Parliamentary Elections

There’s now a strong possibility the European Parliament won’t finalize proposed medical device and IVD regulations before elections this May, a lawyer familiar with the legislation says.

The process for passing the regulations, which will replace the current medical device directives, is about two-thirds complete at this point, said Erik Vollebregt, with Axon Lawyers in the Netherlands. But the revised regulations still need to be finalized before the laws can go into force, and no deadline has been set on the finalization process. Disagreements among members of Parliament have delayed action to the point that it’s now pushing up against elections scheduled for May 22-25 throughout EU member states.

“If the Council sits on its hands or keeps disagreeing with each other until the elections, then the rules will just stay the way they are,” Vollebregt says.

One key issue is the use of special notified bodies for high-risk devices, Vollebregt said. The European Commission still needs to establish a system for registering and authorizing SNBs and develop procedures for sharing SNB-generated information with national authorities and publishing assessment reports.

What the Commission has put in place, however, are requirements for notified bodies to conduct unannounced audits. Were you ready for a visit yesterday? Will you be tomorrow?

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