Latest notified body figures from the European Commission, published just ahead of the official designation of Berlin Cert under the Medical Device Regulation, suggest that there is one more designation in the immediate pipeline under the MDR, which has been in force for over a year, but none for some time under the IVD Regulation which applied as of 26 May.
Indeed, apart from this one additional MDR designation to come, the sector will probably have to wait until at least August, and possibly considerably longer, for any further announcements given the latest status updates compared with timescales published in
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