Date of Application for the Medical Device Regulation

Today, May 26, 2021, is the Date of Application for the Medical Device Regulation (MDR 2017/745), one year later than initially planned.

Over the past years, focus has been on the new regulatory requirements for all economic operators, and the pieces are finally starting to come together.

For manufacturers, developing the technical documentation and implementing Article 10 requirements in the quality management system, as well as ensuring sufficient clinical evidence for all medical devices, is mandatory to be able to continue to keep them on the market as CE-marked according to MDR.

Irrespective of existing certificates and softer transition for certain product classes, a system for post market surveillance and vigilance must be in place by today for all manufacturers.

Next to come – The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) on May 26, 2022.

MDR process

Technical documentation for CE marking


Very welcome Frederik Roos!

We are very happy that Frederik has joined our team. Fredrik will hands-on support our clients to safely and effectively navigate through the product development aspects in a regulated environment.
He has 12 years of experience from the medical device industry with many leadership roles within international product development. Frederik holds a M.Sc. in Chemistry and a B.Sc. in Chemical Engineering.


QAdvis News #2 – 2021