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...
MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

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...
SCCS - Final Opinion on Solubility of Synthetic Amorphous Silica (SAS)

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....
TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – Transition to MDR underway for 63% of outgoing Directives certificates

The number of applications for certification under the Medical Device Regulation (MDR) almost doubled to 9,615 last year, according to a survey of notified...
Double peine pour la medtech suisse

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...

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