Europe – EMA official reports on scientific advice pilots for high-risk and orphan devices
A European Medicines Agency (EMA) official provided an update on the agency’s pilot programs aimed delivering scientific advice to manufacturers of high-risk and orphan...
Europe – Team-NB views on implementation of MDR/IVDR Regulations
At the Team-NB general assembly meeting, held on October 9th, the members aligned on a
strategy including operational aspects to respond to the concerns regarding...
Europe – Urgent need to revise the medical devices regulation
The European Parliament,
– having regard to the Treaty on the Functioning of the European Union, and in particular
Article 168 thereof,
– having regard to Regulation...
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...
