Expert Panels Support for Orphan Medical Devices: EMA’s Pilot Programme On 20 November 2024, the Expert Panels published templates to assist manufacturers and notified bodies in applying for advice under the EMA's pilot pr...
Pure Clinical and MDR Regulator at MEDICA 2024 We have just wrapped up an amazing few days at MEDICA 2024, the premier global medical technology trade fair. This year, our focus was on expanding ou...
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
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...
