EU MDR Readiness Assessment Checklist

Use this short checklist to assess what your medical device company needs to do to comply with the EU MDR.
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CONTACT USHow prepared is your company for compliance to the European Medical Devices Regulation (MDR)?
Medical device CE Marking requirements will change 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 ensure compliance to 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.
Related services:
- CE Mark Certification for Medical Devices
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- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
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- UKRP and Brexit consulting for medical device companies