Dear Reader

Happy Monday! Please find below the latest news related to medical devices in Europe.

​

New: MDCG 2024-4

The MDCG 2024-4 describes the safety reporting requirements for performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. It provides guidelines for reporting forms, completion guidelines, definitions of terms, reporting methods, and reportable events. The document also outlines the roles and responsibilities of various entities involved in the performance studies.

​Link to document​

​

Updated: MDCG 2022-9 Rev. 1

This MDCG 2022-9 describes the Summary of Safety and Performance (SSP) for medical devices, as outlined by the Medical Device Coordination Group (MDCG) in accordance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The SSP is intended to provide public access to an up-to-date summary of the main aspects of the safety and performance of the device, and it may include information dedicated to the intended user and, if relevant, the patient. The document outlines the specific template for SSP for devices not intended for self-testing, including sections on device identification, risks and warnings, performance evaluation, and post-market performance follow-up.

​Link to document​

​

A Study and dashboard on reprocessing and reuse of single-use-devices in the EU

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article. This study evaluates how the provisions established in Article 17 MDR have been implemented and how such provisions function in practice. For this purpose, the current market situation for the reprocessing and reuse of SUDs was surveyed and analyzed across 30 European countries (EU-27 plus Iceland, Liechtenstein, and Norway). This report presents an overview of national decisions regarding the reprocessing of SUDs in the countries studied (ranging from permitted to prohibited to no decision taken at all). The study also reports on the certification processes for SUDs by notified bodies, the reprocessing of SUDs by manufacturers and health institutions, and the reuse of purchased reprocessed SUDs by health institutions. Perceived challenges and opportunities as well as actions recommended by stakeholders are included as well. The report closes with a series of conclusions and recommendations for optimizing the implementation of Article 17 MDR in Europe.

​Link to document​

​

Test our EU MDR and IVDR Chatbot for free

We have migrated our EU MDR / IVDR Chatbot from OpenAI to our webpage. With this change, you are now able to use this Chatbot without having a paid subscription at OpenAI. Keep in mind that this Chatbot has nothing to do with our Regulatory Affairs Assistant "Elly" which we are working on.

​Link to Chatbot​

​

Elly - Your personal Regulatory Affairs Assistant

We are working on a solution to interact with regulations in a completely new way. We call it Elly and she will be a much more advanced solution than our current EU MDR and IVDR Chatbot. Sign up now to join the waiting list and be among the first to get access to Elly as soon as we release it.

Learn more and sign up here.

​

We wish you a great Monday!

Your Regulatory Globe Team

​

Follow us on LinkedIn or use our Newsletter App: Apple / Android​

Regulatory Globe Tools and Services: Link​

​