On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption…
Initiatives to reform MDR and IVDR
Since the Medical Devices Regulation (MDR) and the In-vitro Medical Device Regulation (IVDR) came into full force, several individuals and associations have raised concerns regarding…
Public Consultation on EU MDR & IVDR is now open
On 12 December 2024, the European Commission launched a feedback period for a targeted evaluation of EU regulations on medical devices and in vitro diagnostics.…
Q&A and form for notification obligation for supply interruption or discontinuation
From 10 January 2025, manufacturers of medical devices and in vitro diagnostics (IVDs) must notify the relevant competent authorities and economic operators of any interruptions…
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…