One-year delay for MDR Implementation confirmed
One-year delay to implementation of MDR
Following their statement on the 27th March 2020 to propose postponing the implementation of the Medical Device Regulation (MDR) for one year the European Commission has now confirmed that the date of application of the MDR has now been put back to 26 May 2021.
The reason for this has been stated as relieving competent authorities, notified bodies and manufacturers of the pressures of coping with COVID-19.
The extra time however, shouldn't be a green light for medical device manufacturers to sit back and relax! It’s more important than ever for you to ensure you have a thorough understanding of both the MDR, what it means to your business and products and the continually evolving regulatory landscape.
Mi3 are continuing to conduct MDR readiness activities and are prepared to assist manufacturers of medical devices affected by the changes. Call us to discuss on 01254 678 398.