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.

• Daniele Lioi is a Senior Consultant and Team Manager of the Eurofins Italian Medical device consultancy team. Since 2017, he has been dealing with Biological Risk assessments, Clinical Evaluation and Supporting the compilation of the technical documentation for medical device manufacturers. He has a biotechnology background with experience in regulatory affairs of medical devices. Daniele recently obtained the qualification as Auditor/Lead Auditor ISO 13485/ISO 9001, he is included in the national registry for person responsible for regulatory compliance and he joined the HAS consultants team for the harmonization of International Standards.

• Orly Shenkar has a BSc and MSc degree in Biotechnology Engineering and extensive experience in Quality and Regulation of Medical Devices with global companies. She builds, manages and implements Quality management system from design and development through production and post-market approvals. Orly’s specialty is in the field of Active, Active Implantable, Software Devices and Cardio vascular devices.