The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

EU Device Rules Move Forward, As Trilogue Members Agree to Updates

July 8, 2016

It’s the final countdown for those long-awaited updates to regulations governing medical devices and in vitro diagnostics in Europe.

Last week, the Netherlands presidency of the Council and representatives of the European Parliament reached an agreement for the new rules that, among other things, seek to improve the quality of notified bodies.

Many in industry thought progress on the trilogue would be swifter after the European Council gave the green light to its MDR and IVD legislative proposals. Now, however, industry has some clarity on a path forward.

While the updates are subject to the approval by the Council’s Permanent Representatives Committee and Parliament’s Environment, Public Health and Food Safety (ENVI) Committee, publication is expected this year. Gert Bos, executive director and partner at Qserve Group, said that the trilogue process should make for a smooth path for the regulations.

“So, the anticipation is that besides some minor remarks, they [should] go through smoothly.”

Notified bodies already have faced intense scrutiny, with many already exiting the arena. Bos said that there are, unofficially, fewer than 50 left. NANDO, the EU’s database of Notified Bodies, lists 60, but experts in Brussels are saying there could be as few as 40 left by the end of the year, he added.

“Most of them will apply for the MDR, and as a first round of joint assessment has been done,” with most expected to make the transition, he said. Initially, there will be an estimated 25 to 30 notified bodies under the MDR.

At last fall’s Regulatory Affairs Professional Society Convergence Conference in Baltimore, Md., Bos told attendees that 25 percent of notified bodies have stopped operations ahead of the regulations. He added that it isn’t outside the realm of possibility that another 25 percent could disappear.

Even after the next round of approvals, there could be further delay, as the regulations will need to be translated into all EU languages. That process could take some time, Bos said.

If the ENVI committee approves it in August, it is likely to be published this year, he said. However, industry still could see a Q1 2017 publishing date.

Despite this potential delay, Bos had nothing but praise for the negotiators and Dutch presidency, particularly as there were some “fundamental debates” over IVD regarding genetic testing and counseling.

“Earlier in the year there still was a lot of ground to cover,” Bos said. “The last two Trilogues in May were mainly focusing on transition and IVD, so generally people were anticipating at least the MDR to go through.”

Serge Bernasconi, CEO of industry group MedTech Europe, acknowledged the importance of the updates, adding that the implementation will require “substantial resources from all stakeholders.”

However, he emphasized the importance of keeping “the overarching goals of patient safety and innovation in mind during the translation into implementable rules.”

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