EU MDR Readiness Assessment Checklist
How prepared is your company for compliance to the European Medical Devices Regulation (MDR)?
Medical device CE Marking requirements have changed substantially under the MDR, so firms should have a clear understanding of how far along they are as well as what they still need to do to comply with the new Regulation and maintain European market access.
Our European MDR Readiness Checklist helps you assess what you’ve already accomplished in terms of gearing up for the new Regulation, as well as identify which areas require attention to satisfy new requirements. Issues covered in the checklist include:
- Whether your medical device classification will change under the MDR;
- Whether your current quality management system meets MDR requirements;
- Whether a gap analysis between your current Medical Devices Directive (MDD) and MDR compliance is needed;
- Whether your current Technical Documentation can meet MDR requirements
Learn how far your company has to go to reach MDR compliance for CE Mark certification with our Checklist.
Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.