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

13.30 - 14.00   Coffee & mingling
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
                       Julia Frese, Senior Director Global Certification Bodies, Tüv Süd (Confirmed)
 
16.40 - 16.50 Wrap-Up and conclusions by Medicoindustrien
16.50 - 17.30  Mingling

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.