Europe – MDCG 2021- 23 : Guidance for notified bodies, distributors and importers on...
Article 16(3) of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) introduces requirements on the quality management system to be established by distributors...
Europe – Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation
The In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the...
Europe – MDCG 2022 – 5 : Guidance on borderline between medical devices and...
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...
Europe – CAMD Statement – 50th CAMD Plenary meeting
In the context of the French Presidency of the EU Council, during its 50th plenary meeting, CAMD adopted a statement, following discussions about transition to...
UK – Implementation of the future regulation of medical devices and extension of standstill...
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
Switzerland – Dealing with certification gaps (MDCG 2022-18)
Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in...
Europe – MDCG 2021-13 Questions and answers on obligations and related rules for the...
This Q&A is a document aimed at addressing questions relating to the registration in
EUDAMED of actors other than manufacturers, authorised representatives and
importers subject to...
Europe – Eudamed update: Additional data entry modules now online for European medical device,...
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.
The...
Europe – MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic...
This notice is addressed to manufacturers of in vitro diagnostic medical devices
(IVDs) with the intended purpose to detect and/or quantify markers of SARS-CoV-2
infection1 who...
Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system...
This document presents questions and answers on the Unique Device Identification system
(UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation...
