Latest industry news and developments
Yesterday, our colleagues Katarzyna Szatraj, PhD and Ilona Korczak-Cegielska attended a very interesting conference on the occasion of International Clinical Trials Day, organized at the WUM Didactic Center under the theme "Clinical trials are for you".
Today, Katarzyna Wesołowska and Adam Sobantka, the CEOs of MDR Regulator and Pure Clinical, are participating in the very interesting Kapitał Na Zdrowie conference organized by InnerValue Sp. z o.o.
The 5th National Scientific Conference on Polymers in Medicine is Behind Us!
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 […]
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 […]
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.
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.
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.
“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 […]
