TOPRA In Sweden - Medical Devices: New Regulations for IVDR

TOPRA In Sweden - Medical Devices: New Regulations for IVDR
This evening is an ideal opportunity to discuss the new In Vitro Diagnostic Medical Devices Regulation (IVDR), which will be fully implemented from 26 May 2022. Background and EU Commission perspective. How is the work at the Medical Products Agency affected and how do the companies prepare? What applies to clinical performance studies on IVD products?

Date:  16 November 2021
Time: 17:30-20:00 GMT / 18:30 – 21:00 CEST
Location: Online

Open to anyone who works with and is interested in regulatory questions for pharmaceuticals and medical devices.

The meeting is planned at the Medical Products Agency (limited number) and Online due to covid-19, and will follow at the time of the meeting current recommendations from the Public Health Agency of Sweden

This presentation will be conducted in Swedish. 


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

18.35 – 18.40 MPA and Medical Devices
Björn Eriksson -  Medical Products Agency, Uppsala

18.40 – 18.55 EU Commission perspective
                                Background and Objective
                                From planning to reality
Erik Hansson - Senior Advisor to the European Commission

18:55 – 19:25 IVDR work from the MPA's perspective
                                Status within the EU work
                                National implementation
Ola Philipson - Medical Products Agency

Short break

19:35 – 20:05 How does IVDR change the work at the company
                               Planning / preparation
                               Classification of products
                               Clinical evidence
                               Post market surveillance
                               Ann-Cathrin Jareman / Elinor Nicolaou - Scandinavian Regulatory Services

Short break

20:05 – 20:35 Clinical performance studies of IVD products
                              Application procedures pending EUDAMED
                              Safety Reporting Procedures
                              National legislation
Elin Karlberg - Medical Products Agency

20:35 - 21:00 Time for questions


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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16/11/2021 17:30 - 20:00
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