To mitigate risks of shortages the EU Commission has proposed a longer transition period to adapt to new rules as foreseen under the Medical Devices Regulation (MDR). The new deadlines depend on the medical devices' risk class and will ensure continued access to medical devices for patients. The proposal also allows for medical devices that have been placed on the market in accordance with the current legal framework to remain on the market (i.e., no ‘sell-off' date). The same applies with respect to products regulated by the In Vitro Diagnostic Medical Devices Regulation (IVDR). The aim of the proposal is to ensure patients’ access to a wide range of medical devices while transitioning to the new legal framework.
The proposal now needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.
Other key elements of the proposal and information is available HERE.
If you have any questions, please feel free to contact Hammarskiöld's Life Science team.