Check information about EU Medical market ⚕️ Pure Clinical

MDR Regulator at MEDICA 2024

MEDICA 2024 has concluded, and it was an incredible experience for our team at MDR Regulator. The world’s largest medical technology fair provided a u...

Katarzyna Wesołowska Board Member

Poland Among Top Global Exporters in Medical Devices and Pharma: Insights from the 2024 Report

This autumn, the Polish Agency for Enterprise Development (PARP) published the "Medical Devices and Pharma Sector in Poland – 2024 Report." The report...

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 Board Member

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 Senior Regulatory and Clinical Affairs Consultant

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...

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