Switzerland – Switzerland, too, extends medical device certifications to safeguard supply
Switzerland plans to extend the certification of medical devices to match changes in the EU and reduce the risk of supply disruption.
Recently, the EU...
Europe – Cyber Security
The increasing number of connected medical devices and ongoing digitisation in healthcare
brings new market opportunities for the manufacturer and, more importantly, improvements in patient...
UK – Extension of CE certificates
The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new...
Europe – The designation of notified bodies under the upcoming Artificial Intelligence Act
Artificial Intelligence (AI) algorithms, in its various forms, machine learning, deep learning, etc., implemented as embedded software (SW) or standalone SW, are gaining in...
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...
Europe – MDR/IVDR survey shows NBs have increased capacity
A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in...
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...
Europe – Convergence: MDR timeline extension is smoothing transition, but concerns persist
The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process...
Europe – MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on...
