Canada – Amendments to the Medical Devices Regulations to address future public health emergencies
On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use...
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...
USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
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...
Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical...
