EU Draft Regulation on Annex VII – Medical Devices
The European Commission is taking steps to bring more clarity and consistency to conformity assessments under the MDR and IVDR for medical devices and in vitro diagnostic medical devices. A new draft Implementing Regulation aims to harmonize quality management and procedural requirements for Notified Bodies, addressing identified differences in practices such as varying timelines, cost transparency, and re-certification activities. The public consultation closed on January 23, 2026, allowing stakeholders concerned by conformity assessment activities to provide feedback on rules that may impact manufacturers and Notified Bodies across the EU. As a Notified Body designated under both the MDR and IVDR, DEKRA closely follows regulatory developments affecting conformity assessment activities for medical devices and IVDs.
Scope and main elements of the proposed Regulation
The European Commission has published a draft Implementing Regulation introducing harmonized quality management and procedural requirements that further clarify and specify the application of Annex VII of the MDR (EU) 2017/745 and IVDR (EU) 2017/746 for conformity assessment activities performed by Notified Bodies.
The proposed Regulation aims to address divergent interpretations and practices observed since the application of the MDR and IVDR, particularly in relation to quotations, timelines for conformity assessments, handling of interruptions, monitoring and reporting of costs and performance, and re-certification activities. By setting clearer and, in some cases, maximum timelines and minimum information requirements, the initiative seeks to improve transparency, predictability, and consistency across the EU, while maintaining the level of health protection established by the Regulations and supporting manufacturers, including small and medium-sized enterprises (SMEs).
Public consultation and stakeholder involvement
A public consultation on the draft Implementing Regulation was open until January 23, 2026 (Medical devices – uniform application of the requirements for notified bodies). Input from stakeholders is expected to inform the finalization and adoption of the Implementing Regulation. Notified Bodies and manufacturers may wish to monitor further developments as the legislative process progresses.
Key themes for consideration in the public consultation
Stakeholders were invited to consider the following aspects of the draft Implementing Regulation during the consultation process:
- Feasibility of maximum timelines
Whether the proposed maximum timelines are achievable across all device types, particularly for complex, innovative, or high-risk devices, and where assessments depend on external inputs (e.g. expert panels, EU reference laboratories).
- Flexibility for case-specific complexity
The extent to which the Regulation allows sufficient flexibility to adapt timelines and assessment depth to device novelty, technological complexity, and the quality of manufacturer submissions.
- Administrative and resource impact on Notified Bodies
The operational implications of new monitoring, reporting, and publication requirements on timelines and costs, especially for smaller Notified Bodies.
- Interpretation and comparability of cost transparency data
Potential risks that published cost and timeline indicators may be interpreted without sufficient contextual information, leading to comparisons that do not fully reflect differences in scope, device complexity, or assessment models.
- Contractual and procedural implications
How the detailed rules on quotations, interruptions, and cost adjustments may affect contractual flexibility and risk allocation between manufacturers and Notified Bodies.
- Scope and proportionality of re-certification requirements
Whether the proposed re-certification framework sufficiently avoids duplication of initial assessments while still ensuring alignment with state-of-the-art and post-market experience.
Related EU legislative developments
Proposal to simplify rules on medical and in vitro diagnostic devices
On December 16, 2025, the European Commission published a Proposal for a Regulation aimed at simplifying and reducing the regulatory burden for medical devices and in vitro diagnostic medical devices. The proposal amends the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), as well as related legislation concerning the role of the European Medicines Agency and Union harmonization rules.
The initiative seeks to streamline procedures, improve efficiency, and address implementation challenges while maintaining high standards of patient safety. This proposal is separate from, but relevant to, the draft Implementing Regulation clarifying Annex VII requirements. More information can be found here: