Europe – MedTech Europe signs joint healthcare statement highlighting how the AI Act can...
In the joint statement, healthcare stakeholders representing patients, healthcare professionals and industry, share their views on how the AI Act can give citizens the...
UK – MHRA issues new guidance on the use of life saving adrenaline auto-injectors
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during...
Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...
Europe – Euro Convergence: Experts call for more IVD-specific guidance during IVDR transition
Notified body representatives say that when regulators develop guidance for the In Vitro Diagnostics Regulation (IVDR) they need to get more input from IVD...
Europe – UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the...
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with...
Europe – GUIDANCE on the content and structure of the summary of the...
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of...
Europe – Team-NB : Best Practice Guidance for the Submission of Technical Documentation under...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
UK – Medical devices – extended acceptance of CE marked medical devices on the...
A statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great...
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...
Europe – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
Publiée pour la première fois en 1977, la norme IEC 60601-1 décrit les exigences générales de sécurité et de performances applicables aux dispositifs électro-médicaux....
