Check information about EU Medical market ⚕️ Pure Clinical

Pure Clinical and MDR Regulator at the 4th International Conference “WE! Are the Clinical Research” in Warsaw

On October 10-11, representatives of Pure Clinical and MDR Regulator, Katarzyna Wesołowska and Małgorzata Pawlikowska, had the opportunity to particip...

Regulatory Status of Ethylene Oxide (EtO) for Sterilisation of Medical Devices: MDCG 2024-13

On October 29, 2024, the MDCG released guidance document MDCG 2024-13, clarifying the regulatory status of ethylene oxide (EtO) when used for sterilis...

Team-NB’s perspective on MDR and IVDR implementation

Team-NB emphasizes the importance of streamlining regulatory processes, supporting small and medium-sized enterprises (SMEs), and maintaining efficien...

Katarzyna Wesołowska Vice President of the Board

Medical devices. Group of oxygene ventilators.

Changes in MDCG guidance – borderline products: medical devices & medicinal products

On October 29, the Medical Device Coordination Group (MDCG) published an updated guidance document, "MDCG 2022 – 5 Rev. 1," which provides essential u...

Agnieszka Czajkowska

MHRA: Changes in Post-Market Surveillance of medical devices

The UK government is set to introduce new, strengthened Post-Market Surveillance (PMS) requirements for medical devices, emphasizing patient safety an...

MedTech Europe Report 2024: Insights into Europe’s Medical Technology Sector and Poland’s Role

In July 2024, MedTech Europe released its highly anticipated "Facts & Figures 2024" report. This comprehensive document provides in-depth insights int...

Transitional provisions for the certification of Class D in vitro diagnostic (IVD) medical devices under the IVDR

The document MDCG 2021-4 Rev. 1, published by the Medical Device Coordination Group (MDCG), provides detailed guidelines on the transitional provision...

Changes in Code of Conduct for Notified Bodies according to MDR and IVDR – harmonization of activities in the EU

Team NB has released an updated version of the Code of Conduct for Notified Bodies, introducing key changes in line with current EU regulations on med...