Europe – MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the...

The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What...

On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s...

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...
TEAM-NB : Survey on NBs applications against IVD new regulation

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

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MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies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

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...

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