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Notified Body Coordination Group - Medical Devices

NBCG-Med

https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/overview This group allows notified bodies to share experiences and exchange points of view on the application of conformity assessment procedures. Develops technical recommendations and builds consensus on issues related to conformity assessment. Advises the Commission, at its request, on medical device legislation. Prepares reports on ethical aspects of the activities of notified bodies. It ensures consistency with the standardization work carried out at European level.

Lobbying Activity

Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics

6 Oct 2025

NBCG-Med Summary for EU COM Survey Submission NBCG-Med fully supports the objectives of the EU MDR and IVDR regulations to establish a robust, transparent, and sustainable framework that ensures high safety standards while fostering innovation. However, based on extensive data collection among notified bodies, NBCG-Med identifies several areas for improvement to enhance regulatory efficiency and harmonization across Member States. Key Findings and Recommendations: 1. Designation Process of Notified Bodies (NBs): o The average MDR designation timeline from 2020 to 2024 was approximately 1100 days (~3 years), with significant delays attributed to the acceptance of CAPA plans. o Although NB capacity is now sufficient (50 NBs designated by June 2025), streamlining the designation process remains essential to prevent future bottlenecks. 2. Challenges in MDR Implementation: o Manufacturers often submit applications without genuine intent to transition to MDR, creating artificial workloads. o Frequent change requests for legacy devices and expired MDD certificates under transitional provisions strain NB resources. 3. Structural and Operational Issues: o Duplication of data across regulatory documents (e.g., TD, PSUR, vigilance reports) increases administrative burden. o A more integrated, digital approach to data submission is recommended. 4. IVDR-Specific Concerns: o Implementation of EU 2024/1860 is complex and resource-intensive. o The 5-factor coding system is overly granular, leading to ambiguity and limiting NB designation scopes. o Advanced diagnostics (e.g., NGS) face regulatory uncertainty, delaying market access. 5. Governance and Horizontal Legislation: o While central governance could reduce national discrepancies, NBCG-Med warns against potential loss of local expertise and increased costs. o Integration of horizontal legislation into MDR/IVDR is recommended to resolve conflicting requirements.
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Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

20 Mar 2025

NBCG-Med supports the aim of the regulations to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. However, we welcome the improvement of the regulatory framework in the medical devices sector to enhance harmonization and effectiveness whilst ensuring a high level of patient safety. The EU MDR and EU IVDR are logical frameworks that enhance device quality, patient safety, and transparency. These regulations promote closer monitoring of devices, covering both clinical and post-market aspects, and emphasize ongoing QMS oversight, which increases device safety throughout the lifecycle. By requiring manufacturers to monitor their devices and generate their own clinical data, the regulations help reduce defects and malfunctions, improving the reliability and performance of medical devices in the European market. Member States need a consistent and transparent EU-wide approach for device qualification and classification, standardized requirements among NBs, and simplified NB coding and UDI-DI requirements to support harmonization efforts. NBCG-Med supports creating a "Special Pathways" process to facilitate conformity assessment of devices such as orphan, pediatric and breakthrough devices with involvement of either a Special Pathway MDCG Working Group or Expert Panel. To broaden the use of structured dialogues, clarifications are required to specify permissible discussion topics and organization. NBCG-Med supports creating a process for early dialogue between manufacturers and NBs complementing 'structured dialogue' without the risk of being regarded as consultancy. Early dialogues would help to streamline conformity assessments and bring predictability to the system, which supports innovation and benefits all stakeholders The 100% review of vigilance by Notified Bodies leads to redundant work without improving safety. To increase efficiency, clarify vigilance notification responsibilities, focusing mandatory notifications on CAs and using spot-checks in QMS assessments by NBs. MDCG guidance documents are useful for interpreting MDR/IVDR requirements. To manage the vast amount of guidance, it is recommended to clean up and consolidate existing documents, develop future guidance through a harmonized process with clear deadlines, and use Common Specifications more frequently. A procedural approach would facilitate digitalization and improve conformity assessments by avoiding duplicate review. Additionally, there is an urgent need for guidance on substantial changes under MDR/IVDR. Re-certification activities, performed at least every five years, are based on a summary of all changes, focusing on initial documentation and substantial changes. Changes to Annex VII should clarify that certificate renewal doesn't require new numbering, re-evaluation of initial documentation and QMS certificate re-certification doesn't necessarily need a dedicated audit. NBCG-Med recommends a process-based certification approach with predictable timelines, including clock stops, indicating the time the NB spends on each phase, excluding time taken by external entities/ processes. NBCG-Med acknowledges the proposals to create a single governance structure for NB designation and monitoring. However, a diverse network of NBs ensures fair market access for manufacturers of all sizes. A central governance structure could reduce competitiveness, increase costs, and require significant expertise, potentially leading to a loss of local knowledge and adverse impact on patient safety. Applying both MDR/IVDR and horizontal legislation to the same device may cause conflicting requirements; integrating relevant provisions related to device safety into MDR/IVDR could resolve this issue. The above is a shortened version of the attached file 'Targeted evaluation written feedback_NBCG-Med'.
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Meeting with Flora Giorgio (Head of Unit Health and Food Safety) and The European Association of Medical Devices – Notified Bodies

17 Feb 2025 · Opportunities for the improvement of harmonisation and predictability of conformity assessment procedures under MDR / IVDR. Involvement of Commission representatives during the NBCG-Med plenary meeting planned in April 2025.