October 2018 updated 2020
New European Medical Device Regulation 2017/745 Date of Application 26 May 2021
European authorized representatives and others have recently cited an apparent lag in medical device manufacturer preparedness for the new European Medical Device Regulation 2017/745. ComplianceAcuity has always been on the cutting edge of organic compliance with European device requirements, with its Principal one of the inaugural small group of individuals in the world to achieve the European Union Regulatory Affairs Certification (EU RAC). Please contact us for more information on how we may be able to help you complete your EU MDR transitional efforts.