The number of applications for certification under the Medical Device Regulation (MDR) almost doubled to 9,615 last year, according to a survey of notified bodies. Team-NB, the notified body trade group, said its members have received filings for 63% of the remaining certificates issued under the outgoing device directives.
Team-NB (The European Association Medical Devices – Notified Bodies), surveyed its 33 members to understand the state of the sector and gauge the progress of the transitions to MDR and the In Vitro Diagnostic Regulation (IVDR). One takeaway is that 2022 was the biggest year yet for submissions for certification under MDR. Team-NB called the trend “good news,” while cautioning about getting too encouraged by the evidence of an acceleration in the transition to the new regulations.
“Be aware that this positivity needs to be considered, as many applications are for smaller scopes than those on the Directives certificates. We are told that it is mainly because MDR Technical Documentations for all devices are not ready. Moreover, it is to be noticed that the new legislation will require more certificates issued to the MDR Regulation than were issued to the Directives. For example, a certificate will be issued for each class IIb implantable device,” according to a press release from Team-NB…
