Dive Brief:
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The European Commission has designated two more notified bodies under its incoming medical device and in vitro diagnostic regulations.
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MedCert, a German notified body, received approval to assess products under the medical device regulations on Dec. 25.
- That nod came the day after the EC cleared the Dutch wing of BSI to assess products under forthcoming IVD regulations.
Dive Insight:
MedCert was the ninth notified body to be designated under MDR. The BSI Netherlands unit was the third notified body designated under IVDR.
That is a fraction of the number of notified bodies designated to assess products under the outgoing medical device and IVD rules. However, the notified bodies authorized under MDR so far are among the bigger organizations in the sector, meaning the loss of capacity is less severe than it may appear from a comparison of the numbers of groups designated under the outgoing and incoming rules.
In the latest version of its rolling plan, the Commission estimates that the notified bodies designated under MDR so far cover “about half of existing certificates.” The Commission expects that figure to climb as it aims to belatedly hits its target of 20 designations in the first quarter of 2020.
The Commission’s forecast suggests the acceleration in the pace of designations seen in the second half of 2019 will continue into the new year. However, there remain concerns that too few notified bodies will be in place to handle the MDR workload. European regulators moved to mitigate some of those concerns late in 2019 by delaying the MDR compliance deadline for some Class I medical devices by four years.
Both sets of designations include one notified body based in the U.K., which is due leave the European Union early in 2020. U.K.-based notified body BSI set up its Dutch unit to ensure it can continue to designate devices and IVDs after Brexit.
