Europe – Overview of language requirements for manufacturers of medical devices
The Commission and Member States have created MDR and IVDR tables.
These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
UK – Implementation of medical devices future regime
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. The...
Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations...
In the case of implantable devices and class III devices, clinical investigations shall be
performed, except if:
— the device has been designed by modifications of...
Switzerland – New organisational structure with separate Medical Devices Surveillance Sector
For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area....
UK – Heart vests to identify those at high risk of sudden cardiac death
In the UK, heart rhythms affect around two million people and can cause sudden death.
A re-useable heart vest developed by researchers from University College...
UK- Wearable technology to be offered to thousands with type 1 diabetes in UK
The condition affects around 270,935 people in England and 16,090 people in Wales.
The National Institute for Health and Care Excellence (NICE) has published final...
Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025...
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening,...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations.
This...
Europe – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products :...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related...
