Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: MDCG 2019-6 Rev.5 - Questions and answers: Requirements relating to notified bodies This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It provides clarifications and guidance on...
2 months ago • 1 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: New: Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices This regulation establishes procedures for joint scientific consultations on medical devices and in vitro...
3 months ago • 2 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: EU MDR 2017/745 - Consolidated version The European Commission has published a new consolidated version where they have integrated the reference to "Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024". The consolidated version can be downloaded with the link below. Link to document Regulation (EU) 2025/117 -...
3 months ago • 1 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Secure your Ad spot today! Regulation and Guidelines: Consolidated Version: Directive 2011/65/EU - of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast) This directive aims to restrict the use of certain hazardous substances in electrical and electronic equipment...
3 months ago • 1 min read
Dear Reader Happy New Year! We wish you a healthy and successful 2025! Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Exclusive Offer for YOU: As a thank you for your loyalty and reading our Newsletter, you will receive a unique offer from us: Regulatory Intelligence Paper by Regulatory Globe GmbH Just use the code: Rp2025x10% during the purchasing process and you get a 10% discount and a payback guarantee within the first 3 Months. Buy...
4 months ago • 1 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: MDCG 2024-15: Clinical investigation reports and their summaries in the absence of EUDAMED The document provides guidance on the procedure for publishing clinical investigation reports and their summaries until EUDAMED becomes fully functional. It outlines the submission process, labeling, management, and storage of these documents in a publicly...
4 months ago • 2 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: MDCG 2024-14 Guidance on the implementation of Master UDI-DI solution for contact lenses This document provides crucial guidance on implementing the Master UDI-DI (Unique Device Identification - Device Identifier) solution for contact lenses under the EU Medical Device Regulation (MDR) 2017/745. Link to document Medical devices AI questionnaire jointly...
5 months ago • 1 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: 1.) Updated: MDCG 2023-3 Rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG has changed and updated several questions. Here are the main changes: Expanded scope: The document now covers both the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical...
5 months ago • 2 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: New Published: MDCG 2024-13 "Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices" It addresses two main scenarios: EtO sterilization during the manufacturing process and EtO used by health institutions for sterilizing medical devices. For manufacturing, EtO sterilization falls within the scope of the Medical...
6 months ago • 1 min read