In January 2026, the Notified Bodies Coordination Group – Medical (NBCG-Med) published a draft guidance document aimed at clarifying the procedures for notification and management of changes under the MDR and IVDR regulations.
Eagerly awaited by manufacturers, this document addresses the operational challenges encountered since the European regulations took effect and marks a significant step forward in change management.
Regulatory Context
The objectives of this draft guide are directly related to the challenges observed in the field.
On the one hand, the very high number of requests for changes has significantly increased the workload of notified bodies. On the other hand, the lack of guidelines tailored to the MDR/IVDR context has led to a lack of clarity and, at times, inconsistent practices.
In this context, the guide has two objectives:
- To provide greater clarity and consistency in the interpretation of regulatory requirements,
- Improve the efficiency of the change management process, particularly by limiting unnecessary notifications.
It should be noted that the guide currently in use (NBOG_BPG_2014_3) was developed in accordance with the Guidelines and no longer fully addresses the current challenges posed by the MDR and the IVDR.
A Structured Approach to Change Management
The project introduces a much more structured and systematic approach. From now on, every change must be:
- identified,
- analyzed,
- categorized,
- and addressed based on its impact on safety, performance, and regulatory compliance.
A Clear Categorization of Changes
The guide identifies three main categories:
- Changes requiring prior approval from the notified body,
- Changes that must be reported without prior approval,
- Changes that do not require notification.
This classification makes it easier to prioritize assessments and avoid unnecessarily overburdening notified bodies.
A Greater Role for the Manufacturer
The guide confirms the manufacturer’s central role in change management.
This person is responsible for:
- the identification and categorization of changes,
- assessing their impact on safety and performance,
- the rationale for the classification chosen,
- documentation and traceability of changes,
- planning and implementing changes.
The notified body then takes targeted action, depending on the level of risk associated with the modification.
👉 This development confirms a shift toward greater responsibility for manufacturers, in line with the principles of the MDR and the IVDR.
A Clear Distinction Between Types of Changes
The guide also provides a detailed breakdown of the changes based on their nature:
- Changes to the quality management system (QMS)
(processes, sites, critical suppliers, technologies), - Changes to the scope of certification
(addition or removal of device categories), - Changes to the devices themselves
(design, software, materials, performance, clinical data, etc.).
Numerous concrete examples are provided to guide manufacturers in their decision-making.
👉 For example:
- The introduction of a new production site or a critical supplier constitutes a major change requiring prior approval,
- Conversely, certain minor changes may simply need to be reported, or may not require any notification at all.
Tools to Improve the System’s Efficiency
The guide also introduces mechanisms designed to streamline the management of changes:
- Combining multiple changes into a single notification,
- Implementation of predetermined change management plans (PCCP).
CCPs make it possible to anticipate certain types of changes and implement them without individual approval, provided they have been previously validated by the notified body.
Operational appendices to guide manufacturers
The document also offers practical tools:
- Appendix A: Summary of Applicable Requirements by Device Class and Certificate,
- Appendix B: Flowcharts to facilitate the categorization of changes and decision-making.
These elements serve as a useful operational resource for the regulatory and quality teams.
What are the implications for medical device manufacturers?
This draft guide involves several concrete changes:
- strengthening internal change management procedures,
- a systematic analysis of the regulatory impact of the changes,
- anticipating the time required for approvals by notified bodies,
- an opportunity to implement PCCPs to increase agility.
Conclusion
This draft NBCG-Med guide provides long-awaited clarification and a more robust framework for managing changes under the MDR and IVDR.
The main developments are:
- a standardized classification of changes,
- an expansion of the manufacturer’s responsibilities,
- better prioritization of evaluations by notified bodies,
- the introduction of practical tools to streamline the process.
👉 Isocèle Conseil helps you ensure compliance and effectively manage your change management process in accordance with MDR/IVDR requirements.