What is required by the new regulations and how do you get there?

If you are interested in getting the latest news about where the implementation of IVDR is right now and practical tips before the transition, PlantVision Uppsala and STUNS Life science, invites you to an IVDR webinar, where you will gain insights from the Uppsala-based IVD company Mercodia. They will share insights from their own IVDR journey, which they are currently in the middle of. In addition, there will be opportunities for questions and discussions. Welcome!

When: October 14th, 8:45-10:15 (drop-in from 8:30)
Where: Online

In May 2022, the new European regulations IVDR (In-Vitro Diagnostic Regulation) will enter into force, which will have a major impact on manufacturers, importers and distributors of in vitro diagnostic medical devices.

Many question marks remain as to what will change, what impact this will have on various actors, and what the consequences may be in society.

As part of resolving uncertainties and managing uncertainties, we give you a clear overview of what IVDR means and go through the biggest changes such as classification rules, increased requirements for documentation and aftermarket activities.

In our case, we tell how a company has reasoned and is working to lift some of its products from IVDD to IVDR, with reflections on the biggest challenges.

Speakers:

Judith Kairies,
Regulatory Affairs
Consultant & IVDR
specialist, PlantVision AB

Belma Hot,
Regulatory Affairs
Consultant,
PlantVision AB

Pelle Jadeborg,
Managing Director
Quality, Mercodia

Emma Kilstedt,
Project Manager,
Mercodia

The registration is handled by Plant Vision. By pressing the REGISTER button you will be redirected to Plant Vision´s registration form.

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