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
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... Katarzyna Wesołowska Vice President of the Board
European Commission published Notified Body list of standard fees for MDR and IVDR related services In accordance with Article 50 of Regulation (EU) 2017/745 on medical devices and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical... Adrianna Pyrzanowska Regulatory Affairs Associate
You can give your feedback to EC about the draft of Common Specification for highest risk in vitro diagnostic medical devices! Primary responsibility for implementing EU law lies with EU countries. However, some important areas like health the Commission adopts an implementing...
