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Posted 30 October 2018 | By Ana Mulero 

EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns

2803 The road to the new European medical device and in vitro diagnostic regulations (MDR/IVDR) has raised many concerns, but a European Commissioner recently attempted to ease some of these concerns during a plenary session of the European Parliament.
“Many of you said that I am optimistic and calm,” EU Commissioner for Internal Market, Industry, Entrepreneurship and small and medium-sized enterprises (SMEs) Elżbieta Bieńkowska said to a crowd of EU political group leaders late last week. “I would rather put it in other words: I am realistic and confident,” she added. “That does not mean that we are not monitoring proactively everything. But as for now, we are on track and in the timeline and this is the most important.”
Several concerns were raised during the session on MDR/IVDR implementation over the phased-in regulatory overhaul, according to Bieńkowska. These involve the availability and readiness of notified bodies (NBs), the 2020 and 2022 transition periods for MDR and IVDR, respectively. Concerns around Brexit and the European Commission’s (EC) database, Eudamed, were raised during the session as well. 
Bieńkowska addressed these comments with updates on the EC’s work in each of these areas.
Notified Bodies
The EC has received applications from more than half (34) of all NBs for medical devices as of last week, according to Bieńkowska. “There have been no delays in the assessment of NBs that have been submitted to us,” she said, adding, “the first NBs might be available already before the end of this year.” These comments contradict recently reported data from the EC as well as findings from a survey that suggest audits will not be completed on time.
Transition period
“In order to smooth the transition, the two regulations foresee exemption mechanisms under certain conditions,” Bieńkowska noted. These exemptions mainly relate to the “extension of the validity of an old certificate and the exemption of certain devices from the new most strict clinical investigation requirement,” she added. The EC anticipates it would continue to receive applications for these specific exemptions until at least May 2024.
The EC’s data shows that the four UK NBs “have already taken initiatives to adapt to the post-Brexit scenario,” according to Bieńkowska. “The largest UK NB—BSI—is in the process of new designation in The Netherlands and this is expected to be completed in November.” UK NB SGS “already has local offices in Finland and Belgium,” while UL and LRQA “have approached same national authorities for a possible application.” But if there is any additional transition, including for Brexit, there “may be some more time than 29 March 2019,” Bieńkowska said.


“A first release of the plan for the implementation of the functional specifications have been accomplished by the foreseen legal deadline of 26 May 2018 and the draft functional specifications are expected to be ready by the end of this month,” Bieńkowska added. 


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