Concerns that the MDR and IVDR implementation dates cannot be met are escalating, with only 2 out of 60 notified bodies having achieved designation so far.
The European Commission (EC) has released a factsheet warning that manufacturers may not be able to meet the compliance deadlines of 26th May 2020 for the Medical Devices Regulation (MDR) and 26th May 2022 for the In Vitro Diagnostic Medical Devices Regulation (IVDR).
The EC fears that some manufacturers may not be able to meet the deadlines and some may cease production altogether, which will create product shortages and impact patient safety.
The particular issues that could delay compliance are:
- Lengthy Notified Body (NB) designation procedures, which currently take around 18 months – only 2 out of the existing 60 NBs in Europe had achieved designation as of 7th June 2019
- Potential for loss of UK NBs as the UK leave the EU – the UK’s LRQA has already announced that it will not be renewing its NB designation
- Increased workload for those NBs that do achieve designation due to high demand, the need to recertify existing clients and the lengthening of compliance procedures; in particular, the new risk classifications necessitate additional compliance steps for products falling under the aegis of the MDR and an increase in products needing NB oversight under the IVDR (from 20% to 85%)
- Notified Bodies: Designate them faster
- Re-certification: Ensure the procedure works for all products
- Eudamed: Deploy the new database with workable IT specifications and implementation timelines
- (Quality) Guidance: Publish it in the most urgent areas
- Scientific Bodies: Rapidly establish the new expert panels and EU reference laboratories
- Delegated and Implementing Acts: Publish the most-needed ones, including certain ‘system-critical’ common specifications
- Harmonised Standards: Ensure they are available in the highest priority areas first
For further information see MAP’s detailed analysis of the Regulations.