Guidance on clinical investigation reports in EUDAMED absence
MDCG 2024-15 is the first guidance document published by the Medical Device Coordination Group in December 2024. This document provides instructions on how to submit…
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New MDCG Guidance on Master UDI-DI for contact lenses
The Medical Device Coordination Group (MDCG) just published a new MDCG guidance document on the implementation of the Master UDI-DI solution for contact lenses. MDCG…
New Product Liability Directive (PLD): What is changing?
On 18 November 2024, Directive (EU) 2024/2853 on liability for defective products (new PLD) was published in the Official Journal of the EU. The new…
Swiss Federal Council votes in favour of IvDO amendments
On 20 November 2024, the Swiss Federal Council voted in favour of certain amendments to the Swiss IVD Ordinance. The changes address various aspects, from…
European Commission publishes Q&A on EUDAMED roll-out
On 21 November 2024, the European Commission released a Q&A document on the application of Regulation (EU) 2024/1860, addressing the gradual roll-out of EUDAMED. Article…
MHRA opens consultation on future UK Medical Devices Regulations
The Medicines and Healthcare products Regulatory Agency (MHRA) just launched a consultation on the future UK regulatory framework for medical devices (UK MDR). The deadline…
Revised Q&A on vigilance terms and concepts
The MDCG Group (Medical Device Coordination Group) just released a revised version of MDCG 2023-3. This guidance document provides answers to different questions concerning vigilance…
MDCG: Ethylene Oxide in medical devices and Borderline Classification
In October 2024, the MDCG published two documents: one on the regulatory status of ethylene oxide (EtO) used for the sterilisation of medical devices, and…
Notification for interruptions or discontinuations in the supply of medical devices
In its recent Regulation (EU) 2024/1860, the European Commission introduced amendments to the Medical Devices Regulations (MDR and IVDR). One of the main novelties of…
European Parliament votes in favour of MDR & IVDR resolution
Today, 23 October 2024, the European Parliament votes in favour of a resolution to update the Medical Devices Regulations within 180 days. The motion passed…
Updated MDCG 2021-25 on MDR legacy requirements
MDCG just updated its guidance document on the application of MDR requirements to legacy devices and to devices placed on the market prior to 26…
Harmonised standards for aseptic processing and clinical performance studies
On 9 October 2024, the European Commission published new harmonised standards in support of the EU medical devices Regulations (MDR and IVDR). These new standards…
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