As part of our ongoing commitment to keeping you informed of key regulatory developments, we would like to draw your attention to the publication of Implementing Regulation (EU) 2026/977 in the Official Journal of the European Union on 5 May 2026, with entry into force on 25 May 2026.
This Implementing Regulation introduces a significant revision to Annex VII under both the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), introducing provisions related to the conduct of conformity assessment activities by Notified Bodies.
The revision of Annex VII introduces further detail on the application of requirements related to certain Notified Bodies activities:
- Preparation and issuance of quotations.
- Assessment timelines.
- Handling of interruptions during conformity assessment activities.
- Monitoring of performance and associated costs.
- Approach to re-certification activities.
To support you in understanding the regulatory implications of Annex VII revision and the expected next steps, we will also be hosting a webinar. By registering for the webinar, you will gain regulatory insights, learn about implementation considerations, and have the opportunity to ask questions during a live Q&A with our experts.
Transitional provisions
The articles of the Implementing Regulation will be applied on a phased basis, with different provisions becoming applicable between February 2027 and January 2028.
The new requirements apply prospectively. Conformity assessment procedures under written agreements signed before 25 February 2027 will continue under the existing framework, while certain requirements related to monitoring duration and costs will apply only to written agreements signed from 25 May 2027 onwards. In addition, the new provisions on re-certification will not apply to certificates expiring before 25 November 2027.
View & Download the Timeline.
BSI implementation of the updated Annex VII requirements
BSI has initiated activities to incorporate the new requirements into our quality management system and operational processes, ensuring continued delivery of high-quality, consistent, and transparent conformity assessment services. Our focus remains on supporting our clients through these changes while maintaining the scientific robustness and integrity of our assessments.
We encourage you to begin considering how this implementing regulation may influence your future certification planning, particularly in terms of application timing and submission readiness. We will continue to provide further communications aligned with each implementation milestone to support your preparation.
Stay tuned for additional resources and guidance materials that will be released in the coming weeks to support your understanding of Annex VII requirements implementation.
Whether you're starting the certification process, looking to transfer or need to discuss your options, we can guide you through the process. Contact us at medicaldevices@bsigroup.com.
Sincerely,
Maddalena Pinsi
Head of Medical Devices Notified Body
Regulatory Services, BSI
Alex Laan,
Head of IVD Notified Body
