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 ...
MHRA Release New Guidance on Post-Market Surveillance
The MHRA has released a guidance document regarding the Post-Market Surveillance. To offer some background to this newly released guidance document, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 updates the UK Medical Devices Regulations (MDR) 2002 by introducing a new section (Part 4A) that outlines post-market surveillance (PMS) obligations for medical ...
MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
Pursuant to the Q&A document published by the EU Commission, the manufacturer (or any relevant actor on behalf of the manufacturer) will need to inform the competent authority of a interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices using a form referred to as the ‘Manufacturer Information ...
MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
A guidance document has been released on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. To offer some background to this guidance document, Article 77(5) of the MDR mandates that sponsors submit a clinical investigation report to the Member States where the clinical investigation was conducted within one ...
Importance of Importers in the MDR/IVDR
Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), an importer is defined as any natural or legal person established within the European Union who places a medical device from a third country onto the EU market. The key criteria for an importer, as specified in the regulations, are: Obligations of Importers The obligations ...
