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In the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020. Considering the current global scenario and the shortage of devices and other medicinal products, the EC deemed it necessary to focus on ensuring the adequate supply of devices, as usual, instead of stressing more on the transition of the EU MDR.
According to the proposal, the implementation date of the EU MDR was suggested to be delayed by a year. This means, until May 2021, medical device manufacturers can still place their devices in the EU market as per the existing Medical Device Directive (MDD). However, the EU MDR implementation delay may not affect the other timelines such as:
- The grace-period given to the medical device manufacturers (during which the devices can still rely on the valid certificates issued as per the current directive) which, as usual, is said to be ending on May 26, 2020
- Mandatory deadlines for UDI labeling for an MDR-certified device will remain unchanged
- The implementation date of the In-Vitro Device Regulation (IVDR) (EU) 2017/746 will remain unchanged, i.e., it is expected to be effective from May 2022
Although the implementation of the EU MDR has been postponed by a year, manufacturers are obliged to supply safe and efficient medical devices complying with the current regulations across all the EU member states. Are you in plans to market your medical device in the EU to serve the purpose of COVID-19? Ensure you chose the right Regulatory approach. Stay informed. Stay compliant.
