EU MDR Compliance A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The new EU Medical Device Regulation is massive… complex… and confusing… and you must be ready to comply by May 26, 2020.
When the European Union revised its system of rules for medical device manufacturers in 2017, it replaced a longstanding set of directives on specific topics with one large document that covers all aspects of making devices in EU countries.
Not only did they consolidate all the rules, they gave them greater weight. Previously, medical device directives provided guidance but did not have the force of law. The new MDR, however, contains mandates that are legally enforceable by EU member countries.
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing. The report provides:
Definitions of key terms in the EU MDR
Knowing where to find specific requirements in the 150+ page regulation
Checklists that walk you through every aspect of manufacturing, safety and performance requirements
A training tool for employees new to the regulations
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements is the tool that collects all the requirements, explains them and itemized them in an easy-to-use form to ensure compliance.
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