EU importers, requirements from manufacturers

In the context of MDR 745/2017, an "importer" refers to a natural or legal person established within the European Union (EU) who places a medical device from a third country on the EU market.

The importer is considered a key stakeholder in ensuring the safety and compliance of medical devices being introduced into the EU market. They have specific responsibilities and obligations outlined in the MDR to ensure that the medical devices they import meet the required standards and do not pose any risks to patients, users, or the general public.

Some of the obligations and responsibilities of importers under MDR 745/2017 might include: Verification of Compliance, Registration, Cooperation with Authorities, Labeling and Instructions, Handling Incidents and Field Safety Corrective Actions, Post-Market Surveillance.

It's important to note that the MDR places significant emphasis on the role of importers in ensuring the safety and compliance of medical devices. Non-compliance with the importer's obligations could lead to regulatory action or penalties.

This webinar focuses on the regulatory obligation for importers and how to meet them.