German and Irish delegations to the Council of the European Union recently raised concerns with notified body (NB) capacity and the implementation of the EU’s medical device regulation (MDR).
Ahead of a 14 June Council session, the delegations explain how NB capacity “is the most imminent and high-profile challenge,” although system requirements, infrastructure and secondary legislation are additional challenges.
And although the European Commission remains steadfast in its commitment to designate enough NBs in time for MDR’s application date in May 2020, the delegations note that “there will still be significantly fewer” NBs available and there are no data on the capacity that those NBs “will afford the system.”
Only two NBs —BSI UK and TÜV SÜD—have been designated against MDR so far and none under the in vitro diagnostic regulation (IVDR). The expectation is for less than 20 NBs to be MDR-designated by the end of this year, MedTech Europe reported
CEO and founder of UK-based MedBoard Ivan Perez told Focus
the hope is that Ireland and Germany will “bring more clarity to the situation soon.” He argues that “it will be very interesting to know the outcome and whether there will be further action.”
Yet Perez further argued that depending on the source, the information “is very contradictory, as the EC keeps saying that many NBs will be designated by end of 2019, but now the country delegations of two important” medical technology countries “raise concerns about capacity and implementation too.”
The delegations also raised concerns about potential market shortages for some devices that will not be safeguarded under MDR’s grace period.
As for next steps, the Irish and German delegations call on member states to “immediately consider their state of preparedness” for MDR/IVDR implementation at the national level and at a European level and identify and discuss “specific and particular challenges…along with options for solutions to these challenges.” Member states, the EC and, if necessary, the European Parliament should hold further discussion on the matter by year’s end, they added.
The coordinating group established by MDR issued
a Q&A last week on new obligations relating to NBs.