European medical device regulation checklist
Download the EU MDR checklist today to find out what it takes to become compliant and if your business meets these requirements.
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The European Medical Device Regulations changes
As of May 2021, some recent changes have been made to the EU MDR, impacting the way medical device manufacturers operate. As a result, compliance costs have increased and change management processes for medical device manufacturers across Europe have significantly changed. Ensuring compliance for businesses affected by this has become as important as ever and with a handy checklist you can ensure you are in accordance with the latest changes made to the European medical device regulations.
Key takeaways:
Surveillance and vigilance
Ensure your report submissions and internal procedures are cohesive and match the EU MDR requirements.
Evaluation and investigation
Remember to look at the collection of evidence and ethical requirements procedures to ensure they are compliant.
Assessment and marking
Are your present procedures and file structures in line with the European Medical Device Regulations?