This whitepaper has been updated to reflect the one year extension to the Date of Application (DoA) for the European Union’s Medical Device Regulation (EU MDR), due to the COVID-19 pandemic. The EU MDR is officially known as REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 5, 2017 on medical devices. It is amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It will consolidate two existing legal provisions and replace both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC).

The new DoA of May 26, 2021 was approved by the European Parliament in an amendment to the original regulation. The vote to delay was approved by an overwhelming margin on April 17, 2020 and the amendment was published in the Official Journal of the European Union on April 23, 2020.

The Medical Device Regulation is complex and the changes it embodies are significant. Our white paper serves as a first step for medical device manufacturers in the EU Market to better understand the immediate MDR implications by:

  • Analyzing the most influential changes and highlighting their implications for regulated medical device companies
  • Providing practical steps that medical device manufacturers should take as soon as possible to prepare for this substantial change in the European regulatory environment