Europe – Medical devices: Council adopts new measures to help prevent shortages
The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to...
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
Europe – MDCG 2022-21 Guidance on periodic safety update report (PSUR) according to regulation...
The Periodic Safety Update Report (PSUR) has been introduced in Article 86 of the Medical
Device Regulation (MDR) 2017/745. The introduction of the PSUR requirement...
Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity...
This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:
− assessments of...
Europe – MDCG 2020-16 Rev.3 – Guidance on Classification Rules for in vitro Diagnostic...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
UK – MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is taking forward its new ‘regulatory sandbox’, the AI-Airlock, that will provide a...
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...
Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition...
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...
Europe – The European Medical Technology in Figures 2023
Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business leaders and policymakers.
Updated regularly, this platform draws on data from...
