Changes in Code of Conduct for Notified Bodies according to MDR and IVDR – harmonization of activities in the EU

On September 16, 2024, Team NB published an updated version (5.0) of the Code of Conduct for Notified Bodies assessing medical devices and in vitro diagnostic devices. The latest version introduces significant changes aimed at better aligning with the requirements of EU regulations (MDR 2017/745 and IVDR 2017/746), as well as ensuring consistency in the actions of notified bodies supporting the certification process of medical devices within the European Union.

Update of legal references and guidelines in Code of Conduct Team-NB

The new version removes all references to obsolete legal acts (directives 93/42/EEC, 90/384/EEC, and 98/79/EC) and introduces references to updated norms and documents, such as those from the International Accreditation Forum (IAF). The document reflects the current regulations and new standards, as well as guidelines issued by the Medical Device Coordination Group (MDCG).

Transparency and compliance with requirements of MDR and IVDR

The importance of ensuring compliance with EU regulations is emphasized, especially in terms of harmonizing the activities of Notified Bodies. While the adoption of the Code of Conduct remains voluntary, signing it clearly signals that a notified body is aware of its obligations and commits to adhering to high standards in the evaluation and certification of medical devices.

Personnel qualification standards in Notified Bodies

The new version clarifies the rules concerning the qualification of assessment personnel, in accordance with MDCG guidelines (MDCG 2019-14 and MDCG 2021-14). It also outlines procedures for verifying competence and the need to document qualifications of auditors and technical specialists to improve consistency and quality in assessments conducted by the bodies.

Standardization of audit and technical documentation assessment duration in Notified Bodies

The Code provides guidance on how to determine the duration of audits and technical documentation reviews, tailored to the size and complexity of the company and the devices being assessed. The technical documentation will be systematically assessed, particularly for high-risk devices (Class III, IIb, and IVDR Class D).

Unannounced audits according to MDR and IVDR

Changes regarding unannounced audits include increasing their frequency and detailed guidelines for conducting such audits. There is an increased focus on audits for high-risk products, and the conditions under which notified bodies can audit manufacturers’ subcontractors are also specified.

Streamlining certification processes in Notified Bodies

The new version of the Code simplifies and shortens certification processes, especially in cases of recertification and assessment of product changes, where audits or assessments have already been conducted in the previous certification cycle.

The document includes provisions for the transfer of certificates between Notified Bodies in accordance with Article 58 of the MDR and Article 53 of the IVDR, aiming to facilitate this process and ensure certification continuity.

The Code introduces detailed guidelines for handling non-conformities, both during quality management system audits and technical documentation assessments. Manufacturers have up to 30 days to submit a corrective action plan, and the notified body must review and assess its compliance within the same timeframe.

Team NB has committed to implementing transparent communication procedures, not only for audits and certifications but also for managing complaints and appeals related to conformity assessments. The results of assessments will be published transparently to build trust in the certification system.

Summary

The changes introduced in the Code of Conduct are aimed at harmonizing the actions of Notified Bodies across the EU, increasing transparency and efficiency in certification processes, and strengthening oversight of medical and diagnostic devices. With new rules on assessments, audits, and personnel management, these bodies will be better equipped to support the market introduction of innovative, yet safe, medical technologies.