Check information about EU Medical market ⚕️ Pure Clinical

26 May 2024 was the last call to apply for MDR for legacy devices and take advantage of the transitional periods

26 May 2024 was the last call to submit an application for MDR for legacy devices and take advantage of the transitional periods! The first condition...

European Health Data Space (EHDS)

The European Parliament's adoption of the European Health Data Space (EHDS), gives a significant step towards establishing a resilient European Health...

Information from Swiss Medtech on placing on the market

During the shift from MDD to MDR, MDD-compliant devices can only be introduced into the Swiss market until a specified date. Consequently, there's a p...

Emilia Geszczyńska Project Manager

Adam Sobantka Lectures at AGH

Adam Sobantka, President of Pure Clinical, had the privilege of delivering a lecture on the clinical trials of medical devices at the AGH University o...

Our representatives during the BKWM Conference

It was an intense but very valuable time. This week, the delegation from MDR Regulator and Pure Clinical participated in the 2nd National Conference d...

Katarzyna Wesołowska Board Member

Visualization of Investigator Brochure Content

Changes in the Investigator’s Brochure content – MDCG 2024-5

The revised guidance emphasizes the importance of the Investigator’s Brochure (IB) as part of the required documentation, providing technical and clin...

Izabela Chodara and Maciej Dubowik at TUV Nord Conference

Our delegation at the TÜV NORD Polska conference

Another interesting event is behind us. This time, on Tuesday (March 26), representatives of MDR Regulator and Pure Clinical participated in an intere...

Katarzyna Wesołowska Board Member