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...
Europe – EMA to launch scientific advice pilot for high-risk devices in late February
The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...
UK – NHS rolls out artificial pancreas in world first move
Tens of thousands of children and adults living with type 1 diabetes across England are set to receive an ‘artificial pancreas’ in a world-first...
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 – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
Europe – Intellectual property: harmonised EU patent rules boost innovation, investment and competitiveness in...
Today, the Commission has proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new...
Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR
A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under...
Europe – The Future of Europe’s Medical Technology Regulations
MedTech Europe and its members fully support the objectives of the medical technology regulations, In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical...
Europe – Exercer la fonction de PCVRR : où en sommes-nous aujourd’hui ?
Le règlement européen (UE) 2017/745 (RDM) est applicable depuis le 26 mai 2021, et tous les fabricants qui mettent sur le marché des dispositifs...
Europe – User guide for micro, small and medium-sized enterprises
This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...
