Is MDR Uncertainty Undermining NHS Net Zero Progress?
MDD certificates will expire by 2024
The Medical Device Directive (MDD), intended to harmonise laws regarding the manufacture of medical devices sold to the European Union, was effective until May 2021, when it was replaced by the new Medical Device Regulations (MDR).
Manufacturers have a deadline of May 2024 to complete the transition to MDR, but there are serious concerns about how this deadline can be met – a?report?recently issued by The European Commission’s Medical Device Coordination Group (MDCG)?states that more than 17,000 (90%) of currently valid AIMDD/MDD certificates will expire in 2023-2024.
There is a backlog in MDR certification
Data collected from 75% of all relevant Notified Bodies in a?European Commission survey?has revealed that more than half of all applications from manufacturers are incomplete.
Only 8,120 MDR applications have been received and 1,990 have been issued, and for 82% of the applications, the time to obtain a certificate (allowing for QMS and product assessment) was between 13 and 18 months.