La lettre de la biomédecine #5
Des organes animaux chez l’humain : La xénotransplantation au cœur des préoccupations scientifiques et éthiques de demain. En savoir plus.
Catégorie : Relevant news
Is the EU Health Policy Platform right for you? Find out, by taking a quick look at this one-page infographic now available in all EU official languages
This infographic, now available in all 24 official EU languages, explains the main features of the Health Policy Platform and how to become a Platform member. It describes the many benefits the EU Health Policy Platform...
MDCG 2024-12 – Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams
This guidance document is intended for conformity assessment bodies, notified bodies, designating authorities, and Joint Assessment Teams involved in Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices....
MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices (October 2024)
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) – also referred to as ‘qualification’ as an in vitro diagnostic...
MDCG 2021-25 rev.1 – Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 – October 2024
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 from 26 May 2024 until 31 December 2027 or...
Public consultation: Implementing Regulation on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level
Today, the European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medical devices and in vitro diagnostic medical devices at Union level under the Health Technology Assessment Regulation....
MDCG 2022-5 rev.1 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices – October 2024
The demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand...
Q&A Obligation to inform in case of interruption or discontinuation of supply
Q&A on practical aspects related to the implementation of the obligations to inform about interruption or discontinuation of supply of certain devices laid down in Article 10a MDR and IVDR as introduced by Regulation (EU)...
Public consultation: Implementing Regulation on joint scientific consultations on medicinal products for human use at Union level
Today, the European Commission launched an online public consultation on the draft implementing act on joint scientific consultations on medicinal products for human use at Union level under the Health Technology Assessment Regulation. Read the news announcement...
The EU HTA Regulation: Webinar for health technology developers of medicinal products
In this webinar, Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment and its subgroups will explain the process for joint clinical assessments and joint scientific consultations. The webinar is targeted...
