France – La HAS émet un avis favorable à l’octroi d’un forfait innovation pour...
Le diagnostic de l’endométriose peut s’avérer difficile lorsque l’examen clinique en 1re intention et le bilan d’imagerie en 2e intention produisent des résultats discordants. L’utilisation d’Endotest...
Europe – Stakeholders disagree over need for ‘urgent action’ on MDR/IVDR
As medtech companies work to comply with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), stakeholders disagree on whether...
UK – Implementation of medical devices future regime : Implementation of the future regulations...
The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and...
Europe – Règlement d’exécution (UE) 2024/2699 de la Commission du 18 octobre 2024
LA COMMISSION EUROPÉENNE,
vu le traité sur le fonctionnement de l’Union européenne,
vu le règlement (UE) 2021/2282 du Parlement européen et du Conseil du 15 décembre 2021 concernant...
Europe – Open letter to Stella Kyriakides on the urgent need for action on...
On 14 October 2024, together with 39 national associations, MedTech Europe has sent an open letter to European Commissioner for Health & Food Safety,...
Australia – How to submit a custom-made medical device / patient-matched medical device notification...
The following guide is designed to assist you with completing and submitting a:
• Custom-Made Medical Device (CMMD) notification; and
• Patient-Matched Medical Device (PMMD) transition...
Australia – Understanding personalised medical devices rules (including 3D-printed devices) – Regulatory changes for...
Personalised medical devices are devices that are either designed and manufactured, or modified after they are supplied, to suit an individual.
This document provides information...
Australia – Refinements to the Personalised Medical Device Framework
The public consultation indicated the importance of the TGA’s role as the regulator of
medical devices, affirming that in the majority of cases medical devices...
Europe – MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 – application of MDR requirements...
The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR)
have been amended by Regulation (EU) 2023/607. In particular, the transitional period
has been extended...
International – RF Quarterly, September 2024: Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
