Now it is decided: the EU has officially postponed the end of the transition period for the new EU MDR in all bodies until 26 May 2021.
This means that medical devices can be marketed for another year under the current regulations.
However, manufacturers and distributors are well advised to use the time gained to fully align their QMS systems with the new, stricter regulations.
The gempex Medical Devices Team offers consultancy and support.
info@gempex.com
+49 621 819119-0
News from 21.04.2020
Update EU-MDR: EU Parliament has decided to extend the transitional period until 26 May 2021
Now only the Member States have to give their consent for the extension decision to actually come into force.
The Medical Devices Team of gempex is available for consultancy, support or training, if desired also without direct customer visit.
You can contact them via
info@gempex.com
+49 621 819119-0
News from 16.04.2020
EU-MDR: EU Commission has adopted proposal for moratorium
How do manufacturers of medical devices of classes I to III ensure the compliance of their products?
With the adoption of the proposal by the European Commission to postpone the application date of the EU MDR by one year, an important hurdle in the decision-making process has been overcome. Moreover, the Commission appeals to the Council of EU Member States and the European Parliament to adopt the proposal quickly - with a view to security of supply now in the era of COVID-19.
With the adoption of the proposal by the European Commission to postpone the application date of the EU MDR by one year, an important hurdle in the decision-making process has been overcome. Moreover, the Commission appeals to the Council of EU Member States and the European Parliament to adopt the proposal quickly - with a view to security of supply now in the era of COVID-19.
This would give manufacturers of medical devices I to III further time to meet the stricter criteria of the new EU Medical Device Regulation. It would also provide some relief for Notified Bodies and the competent national authorities such as BfArM or ZLG.
Companies can now use this time to ensure that technical documentation and quality management systems are compliant. A GAP analysis is a suitable instrument here to check the QM system for possible weaknesses. If a need for action is identified, there is still sufficient time to implement the necessary measures and remediate the QM system.
The Medical Devices Team of gempex is available for consultancy, support or training, if desired also without direct customer visit.
You can contact them via
info@gempex.com
+49 621 819119-0