European medical device regulation checklist
Stay compliant with the latest European Medical Device Regulations (EU MDR) using this comprehensive checklist designed for medical device manufacturers.
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Navigating the changes to the EU MDR
As of May 2021, new changes to the EU Medical Device Regulations (MDR) have significantly impacted the operations and compliance processes of medical device manufacturers across Europe. This checklist is designed to help businesses navigate these changes and ensure compliance, reducing the risk of costly penalties and delays in product approval.
Why you need this guide
Gain practical insights to ensure your organization is compliant with the latest EU MDR requirements.
Surveillance and vigilance
Ensure that your internal procedures and report submissions are in line with the EU MDR requirements for ongoing product surveillance.
Evaluation and investigation
Check that your evidence collection and ethical compliance procedures meet the necessary regulatory standards.
Assessment and marking
Confirm that your file structures, documentation, and assessment protocols align with European Medical Device Regulations.
Digital transformation
Understand how automation, AI, and IoT are revolutionizing the industry, improving operations and passenger experiences.