Trois nouvelles guidances du MDCG en Mars 2020

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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

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...
TÜV Rheinland Becomes 5th Notified Body Designated Under MDR

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,...
Australian regulatory action on breast implants and breast tissue expanders

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...
Australian regulatory action on breast implants and breast tissue expanders

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...
Australian regulatory action on breast implants and breast tissue expanders

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...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA to launch consultation on device international reliance plan by year’s end

The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to publish a public consultation on a proposal to allow medical devices automatic access...

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