This site is intended as a Wiki for the 2017 European Union Medical Device Regulation (EU MDR).
The primarily goal of the site is to be a practical guide to compliance. To simplify the regulation for anyone wishing to supply compliant medical devices to European citizens.
For those already supplying devices in compliance with the original 1993 Directive, this site aims to support your transition by explaining the key changes.
For those complying with the 2017 Regulation from scratch, this site aims to support you by providing interpretation and practical advice.
During the transition years, 2017 – 2024, this site aims to provide you with the latest news and guidance available from the European authorities.