In this webinar, Chairs and Co-chairs of the Member State Coordination Group on Health Technology Assessment and its subgroups explained the process for joint clinical assessments and joint scientific consultations. The webinar was targeted at...
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....
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...
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...
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....
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 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)...
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...
Today, the European Commission adopted an Implementing Regulation that sets out the rules for cooperation with the European Medicines Agency in the joint work carried out under the Health Technology Assessment Regulation. Read the news announcement...
Today, the European Commission adopted an Implementing Regulation that sets out the rules for the management of conflicts of interest of those involved in joint clinical assessments and joint scientific consultations under the Health Technology...
