Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline
European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.
According to the European Association for Medical Devices of Notified Bodies (Team-NB), 84% of notified bodies intend to submit their application in November, 8% intend to submit in December and 8% next year. More than half of the notified bodies also have said they have had to hire additional employees to deal with the process.
Team-NB also noted which notified bodies intend to apply and whether the application will be for the MDR, IVDR or both. The association said it has a working group thatwill provide guidelines to support the members in submitting their application in the quickest time and be ready to pass their designation audit against the new regulations.
RAPS Executive Director Paul Brooks told Focus that the list is part of voluntary disclosures from their members intending to apply for re-designation. He estimates that it may take between six and nine months from application for any notified bodies to complete designation under the MDR, though designations under the IVDR may take longer.
Other notified bodies which are not members of Team-NB may also apply for designation.
Amsterdam-based lawyer Erik Vollebregt noted at the Medical Devices Legal blog on Wednesday that some notified bodies have informed clients that they probably will not apply for accreditation under the MDR and/or IVDR.
"This is of course even more problematic in relation to IVDs because of the low number of notified bodies allegedly applying for accreditation under the IVDR (only five)," he wrote. "Given the quantum leap of self-certified IVDs currently on the market that will need notified body certification under the IVDR (80-90% of the total IVDs will need notified body certification), it is already doubtful if the combined capacity of those notified bodies will suffice. The bottleneck that will occur under the MDR towards the end of the transitional period will likely be much worse [for] IVDs."