We’ve had a very interesting and intense year in our industry, so it’s time for a little summary!

Here’s what’s worth remembering from the vast calendar of 2023:

  • III.2023 – Changes of transitional periods (MDR/IVDR) and removal of the “sell off” periods
  • V.2023 – Advertisement rules for medical devices (PL)
  • VI.2023 – Distributors database (PL)
  • VII.2023 – Update of list of harmonised standards
  • IX.2023 – Changes in biological evaluation standards ISO 10993
  • X.2023 – Further EUDAMED database delays
  • XII.2023 – Reference laboratories list (Regulation No. 2023/2713)
  • XII.2023 – Guidances for Annex XVI products

It is also worth mentioning that we currently have 42 MDR notified bodies and 12 IVDR notified bodies.

A very intense and busy, but also fruitful year for our company. Lots of meetings, even more knowledge and interesting experiences.

We invite you for a small summary. See where you could meet us in recent months!