It has been announced this week that the European Commission (EC) has approved the postponement of the new MDR directive due to come into effect on 26th May 2020. It will in fact be postponed for one full year in light of the Coronavirus pandemic.
The MDR offers vital guidance to manufacturers to ensure medical devices are fully compliant with stringent EC laws and safe for patient use. Major changes were announced back in 2017 to further safeguard patient care and increase transparency on devices in use across the EU. The changes were scheduled to take effect in May.
The delay will be a welcomed and essential extension for companies whose efforts are majorly focused on fighting the ongoing Covid-19 crisis. The Commissioner for Health and Food Safety, Stella Kyriakides, noted that the EC were committed to supporting member states in addressing the pandemic. She explained that “potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided”, during these, “exceptional times”.
“potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided”
Stella Kyriakides, Commissioner for Health & Food Safety
At Perfectus Biomed, our mission is to improve quality of life through customised microbiological testing. Ahead of the original May 2020 deadline and to comply with our commitment, we have solutions in place to help you adhere to the new MDR regulatory guidelines. Let us support your innovations through regulatory support testing and post market surveillance solutions.
The latest MDR announcement comes close to the FDA’s similar short-term guidance review in the U.S. to help ease manufacturers responsibilities at present distracting from their primary focus of tackling the serious pandemic we are currently faced with.
To speak with one of our experts at Perfectus Biomed contact us via email@example.com or call us on 01925 737 238.
For more information on the MDR delay, visit https://ec.europa.eu/commission/presscorner/detail/en/ip_20_589.