Notified Body Proposed Reform: EU Medical Device Governance 

The EU medical device regulatory landscape is at a critical juncture, as concerns grow over fragmented implementation and the urgent need to reform Notified Body regulations under the MDR (EU 2017/745) and IVDR (EU 2017/746).

EU Centralized Reform Regulations Proposed by Notified Bodies

In response, the notified body community (NBCG-Med & Team-NB) has issued a joint perspective on a reformed, more effective governance model for the sector. This joint perspective follows as a response to the Consensus Statement released earlier last month, in which numerous medical device competent authorities urged significant reforms to the EU medical device regulatory framework (MDR/IVDR).  For additional information on the competent authority’s consensus statement, refer to our blog post.  

The Proposal: Medical Device Coordination Office (MDCO) 

At the heart of this vision is the creation of a Medical Device Coordination Office (MDCO)—a centralized body to coordinate core regulatory activities at the EU level, including: 

• Designation, monitoring, and reassessment of notified bodies 

• Guidance development (structural, clinical, and technical) 

• Classification and qualification decisions 

• Consultation procedures with expert panels and reference labs 

• Vigilance coordination and structured oversight 

• Maintenance of a central repository for clinical/scientific data 

• Early advice and support for special pathways 

The MDCO would not add complexity but streamline governance by serving as a central hub for all regulatory coordination. It would act as a unifying interface between competent authorities, notified bodies, manufacturers, and EU institutions. 

Notified Bodies as Strategic Regulatory Partners 

The involvement of Notified Bodies within the proposed MDCO would enable the integration of knowledge on real-world technical, clinical, and operational aspects of medical device regulation. With over 6,200 professionals EU-wide, including 900+ clinicians and 3,700+ technical experts, involvement of Notified Bodies within the MDCO could add value to: 

• Existing and new scientific and technical expert committees 

• Development of guidance and common specifications 

• Early advice and special pathway procedures 

• Classification and delineation discussions 

Their integration into MDCO-led activities- particularly through the NBCG-Med platform- would institutionalize this operational insight, enhance consistency, and build regulatory resilience. 

Special Pathways and Early Advice: Enabling Innovation 

Two new regulatory mechanisms are proposed under MDCO oversight: 

1. Special Pathways: Designed for high-need devices (e.g. paediatric, orphan, or breakthrough), this route allows: 

• Pre-certification assessments tailored to feasibility constraints 

• Post-market evidence development (PMCF/PMPF) 

• Eligibility decisions and guidance coordinated through a Special Pathways Working Group 

2. Early Advice Pathway: Manufacturers can request early regulatory and clinical advice from a notified body. Draft recommendations are reviewed by a designated expert group to ensure consistency and alignment with EU-level expectations. 

Both mechanisms prioritize scientific integrity, confidentiality, and structured follow-up, with opportunities for regulatory learning feeding into future guidance development. 

Funding the MDCO: a Hybrid Model 

To ensure sustainability, the MDCO would be financed through a combination of: 

• EU budget contributions, and 

• Modest user fees (e.g. EUDAMED access, early advice requests, notified body audits) 

This model reflects value delivered and maintains accessibility for SMEs and innovators. 

Centralized Clinical & Scientific Data Access 

To support consistency and proportionality in decision-making, the MDCO would maintain a central repository of trusted scientific and clinical data sources. This would assist manufacturers, notified bodies, expert panels, and competent authorities in conducting transparent, evidence-based assessments. 

Why This Matters 

For industry, this governance reform could: 

• Enhance regulatory predictability and transparency 

• Accelerate access to market for high-value innovations 

• Improve support for SMEs and orphan/pediatric technologies 

• Strengthen EU-wide consistency in assessments and decisions 

How Can MedEnvoy Support  

We actively monitor regulatory developments-such as the EU Notified Body regulations-and support our clients in staying up to date with key changes, ensuring they remain compliant and informed every step of the way.

If you have questions about how these EU medical device reform changes affect your products – or need expert support to ensure continued compliance in the EU – MedEnvoy is here to help. We simplify regulatory complexity, helping you stay focused on innovation and patient outcomes.