TOPRA in Sweden: Medical Devices-Combination Products

TOPRA in Sweden: Medical Devices-Combination Products
This evening is an excellent opportunity to discuss experiences with the new regulations MDR and IVDR which were fully implemented from 26 May 2021 and 26 May 2022 respectively. How have they affected the work at the Medical Products Agency and the companies? How have they affected clinical trials? What applies to combination products, when a medicine contains a medical device component (Article 117)? And what does consultation mean for a medical device with medicinal substance? Open to anyone working with and interested in regulatory issues for pharmaceuticals and medical devices.

 Tuesday 14 February 2023
Time: 17:30-20:00 GMT / 18:30 – 21:00 CET
Please note this is a face to face presentation, conducted in Swedish.
Venue: Medical Products Agency, Dag Hammarskjölds väg 42, Uppsala



18:00 – 18:30 Light refreshments (sandwiches and drinks)

18:30 – 18:35 Introduction
                                Margareth Jorvid, Methra Uppsala AB, LSM group

18:35 – 19:05 How has the MDR/IVDR changed the work at the Medical Products Agency
                               • Experiences
                               • EUDAMED
                               • Combination products
                        Lilian Nilsson, Medical Products Agency

19:05 - 19:35 How has MDR/IVDR changed the work at the company
                               • Experience implementing MDR/IVDR
                               • Combination products
                               • MDR Art 117
                       Ann-Cathrin Jareman, Scandinavian Regulatory Services

Short break

19:45 - 20:15 Clinical testing of medical devices/combination products
                               • Application
                               • Safety reporting
                               • Experiences
                       Elin Karlberg, Medical Products Agency

20:15 – 20:45 Consultation for medical devices with medicinal substance
                               •       Documentation requirements, what does MPA review?
                               • Transition to MDR for MDD products
                               Johan Sällström/Katarina Sundberg, Medical Products Agency

20:35 - 21:00 Time for questions and networking.


TOPRA Members: Free [MPA employees - Free. Use code MPA200]  
Non-member: £45 (includes 2 months TOPRA membership)


Contact us

Contact or Margareth Jorvid at, if you want to become TOPRA member.



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14/02/2023 17:30 - 20:00
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