MDCG 2025-7 MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles
The MDCG has released a position paper regarding the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this position paper, the introduction of the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical ...
Beware of Potential Labelling Issues
A concerned client of Advena has shared their recent audit experience with their notified body, which we believe is worth highlighting to raise awareness. The medical device manufacturer in question had recently withdrawn their UKCA certification. However, during their latest audit for CE certification, a major non-conformity was raised by the notified body due to ...
AIB 2025-1/MDCG 2025-6: Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA). This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and ...
UPDATE: MDCG 2019-11 Rev.1 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
There has been an update to the guidance document MDCG 2019-11 concerning Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. originally released in 2019, this guidance document, aimed primarily at Medical Device Software (MDSW) manufacturers, offers guidance on the following: The criteria outlined in this document ...
MDCG 2025-5: Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746
The MDCG has released a guidance pertaining to Q&A on performance studies relating to IVDR. To offer some background to this document, this document is intended for sponsors of performance studies involving in vitro diagnostic medical devices (IVDs) conducted under Regulation (EU) 2017/746 (IVDR). It also provides relevant information for manufacturers supplying IVDs for use ...
EU Commission to Organise Hybrid Workshop to Support EUDAMED Onboarding
The European Commission is hosting a free hybrid workshop in Stuttgart to support onboarding to EUDAMED, the EU’s database for medical devices. The event will guide stakeholders—such as economic operators, notified bodies, and national authorities—on meeting their obligations under the MDR and IVDR, particularly regarding EUDAMED’s mandatory modules (Actors, UDI/Devices, Notified Bodies and Certificates, Market ...
MEDTECH Europe Issue Decision Making Flowchart Regarding Article 10a MDR/IVDR
Starting from 10 January 2025, Regulation (EU) 2024/1860 introduces new requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), mandating that medical device manufacturers provide information in cases of supply disruptions or product discontinuation. To comply, companies must implement structured internal processes to manage these obligations effectively. To assist ...
UPDATE: MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU ...
EU Publishes Guidance on AI Act
The EU has recently published a guidance concerning the AI Act. The guidelines on defining AI systems clarify the practical application of the legal concept established in the AI Act. By providing these guidelines, the European Commission aims to assist providers and other relevant stakeholders in determining whether a software system qualifies as an AI ...
UPDATE: MDCG 2023-3 Rev. 2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746
The MDCG guidance document MDCG 2023-3 has been updated. Originally published in 2023, this document aims to clarify key terms and concepts outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a shared understanding of these terms ...
