New Version of MDCG 2019-6 Rev.5 Document on Notified Body Requirements

The MDCG 2019-6 Rev.5 document serves as a key guidance resource for notified bodies assessing medical devices under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The latest revision incorporates updated guidelines on independence, personnel qualifications, and audit procedures.

Key Changes in MDCG 2019-6 Rev.5

• New questions and answers clarifying the operational principles of notified bodies.
• Updated requirements for personnel qualifications.
• New guidance on clinical evaluation and surveillance audits.
• Expanded section on transparency in the activities of notified bodies.

Independence of Notified Bodies

The updated document emphasizes the necessity for full independence of notified bodies. Stricter rules on hiring experts and their relationship with medical device manufacturers have been introduced to eliminate potential conflicts of interest and ensure that notified bodies operate independently of the entities they assess.

New Rules on Audits and Compliance

MDCG 2019-6 Rev.5 introduces explicit guidelines for conducting audits at medical device manufacturers, including:

• More stringent verification of technical documentation compliance with MDR and IVDR requirements.
• A requirement to document all identified non-conformities and corrective action strategies.
• Strengthening of post-market surveillance procedures.
• Changes in Technical Documentation Requirements.

The document places significant emphasis on the quality and completeness of the technical documentation submitted by manufacturers. Notified bodies will now be required to conduct a more detailed assessment of the documentation and implement a more systematic approach to monitoring devices already on the market.

Conclusion

MDCG 2019-6 Rev.5 represents a crucial tool for notified bodies and medical device manufacturers, ensuring full compliance with EU regulations. The changes introduced in this revision enhance transparency, the efficiency of the certification process, and patient safety.

Full version of the MDCG 2019-6 Rev.5 document available here