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...
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,...
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...
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...
Europe – Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and...
Europe – Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and...
Europe – MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR)...
