As the full application date of the Medical Devices Regulation (MDR) nears, the Medical Device Coordination Group (MDCG) has released an implementation and preparedness plan to assist all parties in their readiness for the new Regulation.
The MDR comes into full effect on 26th May 2020. Priority areas identified in the plan for further attention are:
- EUDAMED – ensuring the database and systems are live by May 2020 so that actors may comply with the MDR
- Placing safe devices on the market after 26 May 2020 – ensuring aspects of process such as Notified Bodies (NBs) are available for use
- Clinical evaluation and Expert Panels – ensuring nominations for panels are carried out appropriately
- Implementing Acts – ensuring the necessary legislation is in place to enact the provisions of the MDR
The full plan provides a fascinating and cautionary insight into the implementation of the MDR, including concerns around NBs, for example:
“Despite the progress achieved over the last months in terms of designation of notified bodies under the new MDR (and IVDR), concerns remain, for the shorter term, about the capacity of the notified bodies, both in certifying devices under the MDR and in reviewing and renewing existing certificates under the Directives. There is therefore a risk that the validity of existing certificates will gradually expire as from 26 May 2020 without being immediately replaced by a certificate under the MDR, which could potentially lead to shortages of devices essential for healthcare.”