May 28, 2024
Our team during Conference on Polymers
The 5th National Scientific Conference on Polymers in Medicine is Behind Us!
News
Latest industry news and developments
May 27, 2024
Changes in the guidance on MDR appropriate surveillance – MDCG 2022-4 Rev. 2
According to Article 120(3e) of the MDR, the notified body that issued your MDD or AIMDD certificate is still responsible for monitoring your devices to make sure they meet the necessary requirements. This means that their surveillance activities will continue as they did before under the previous Directives. The revised guidance regarding the transitional provisions […]
May 10, 2024
MHRA launches AI Airlock to address challenges for medical devices that use Artificial Intelligence
Last month, the MHRA outlined its strategy for regulating AI in response to a government white paper. This new pilot project aims to address challenges in regulating standalone AI medical devices (AIaMD) by initially supporting 4-6 projects. The goal is to test regulatory issues for these devices when used in the NHS. The regulatory sandbox […]
April 25, 2024
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 potential scenario where certain products currently stocked in Swiss warehouses may become unsellable on May 27, 2024. To mitigate this risk, Swiss Medtech has developed a guidance document.
April 18, 2024
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 dedicated to clinical trials of medical devices.
April 11, 2024
European Commission’s Dashboard about reprocessing of medical devices
The concept of "reprocessing" in the context of medical devices refers to the process of safely preparing a used device for reuse through cleaning, disinfection, sterilization, and related procedures. The European Commission's Directorate-General for Health and Food Safety commissioned a study to evaluate the implementation of Article 17 of the MDR on the EU market. As part of the study, a dashboard has been developed to provide an overview of mapping activities related to the reprocessing and reuse of single-use devices in the EU.
March 26, 2024
Software and legislation and medical devices
“Software in the context of medical device legislation” – this was the slogan of this year’s conference, organized by TÜV NORD Polska. – A very interesting event in terms of content – emphasize our representatives. – A lot of content concerns, among others: software topic in relation to medical device regulations. Generally, a large dose […]
March 21, 2024
Three days at SALMED 2024
– Thanks to the combination of the event with the LABEXPO fair, approximately 300 companies from Poland and abroad and over three thousand visitors visited Poznań during three days – emphasizes Katarzyna Wesołowska, CEO of MDR Regulator. – As an exhibitor, under the Pure Clinical banner, we were there for the first time and I […]
March 7, 2024
New standards for biocompatibility, sterilization and processing have been harmonised
Recently CEN and Cenelec revised the harmonised standards and added sterilization, biocompatibility, and processing standards to the list. The standards and the amendments satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/745. Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements […]