New Implementing Act, Annex VII: Time to Market – Predictability & Increased Transparency
Learn about the new Implementing Act on Annex VII and gain insight into the changes designed to improve predictability, transparency, and consistency in Notified Bodies’ conformity assessments.
Background
Implementing act on uniform application of the requirements for Notified Bodies (Annex VII) was published 4 May 2026 to address inconsistent interpretations of Annex VII by NBs, enhancing predictability, transparency, and consistency in conformity assessments.
The Act introduces maximum timelines for conformity assessments, such as technical documentation review and QMS audits, aiming to reduce delays in certification, including re-certification. Also, the act establishes uniform procedures for Notified Bodies regarding how they request information and provide cost estimates, aiming to reduce fragmentation and improve treatment for SMEs.
Join the seminar and get to know all the important details!
Tentative program
| 14.00 – 14.05 | Welcome by Mads Koch Hansen, CEO, Medicoindustrien |
| 14.05 – 14.20 | Introduction Lene Laursen, Deputy Director General, Medicoindustrien Kaja Tengbjerg, Chief Consultant, Medicoindustrien |
| 14.20 – 15.20 | Overview of the Changes in Annex VII Katrine Bering Klausen, Team Lead, policy and stakeholder management Ida Dalgaard, Lead Auditor of Notified Bodies, The Danish Medicines Agency |
| 15.20 – 15.40 | Coffee break |
| 15.40 – 16.10 | Notified Body Perspective on Deadlines and Collaboration with the Manufacturers Shruti Gangwal, Regulatory Lead, BSI (Confirmed) |
| 16.10 – 16.40 | Perspective Deadlines and Collaboration with the Manufacturers Tüv Süd (Confirmed) |
| 16.40 – 16.50 | Wrap-Up and conclusions by Medicoindustrien |
Who should attend
The seminar is relevant for RA, QA and management of manufacturers of all sizes who want to gain knowledge about Annex VII from both Notified Bodies and The Danish Medicines Agency.
Contact us
Select date
9. september 20269 September 2026 - at 14:00 - 16:50
Price ex. VATLatest Registration
01.09.2026
Latest Cancellation
20.08.2026
Bøge Allé 5, 2. th
2970 Hørsholm
Terms
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Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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