USA – Switzerland eyes allowing FDA-approved medical devices onto its market
The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators,...
Europe – COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down common specifications for the groups...
This Regulation lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.
Annex...
Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
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 – MHRA and international partners publish five guiding principles for machine learning-enabled medical...
The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support...
Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
PARIS (TICpharma) - Un groupe de travail européen sur l'évaluation des dispositifs médicaux (DM) numériques a débuté ses travaux en vue de "parvenir à...
Europe – New European Manual on Borderline and Classification for medical devices and IVDs...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy...
Notified bodies have yet to issue Medical Device Regulation certificates for more than 85% of the products previously certified under the old directives,...
Europe – Normes Harmonisées 2024/817
La décision d’éxecution (EU) 2024/817 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives à la stérilisation des produits de...
UK – MHRA increases UK assessment capacity for in-vitro diagnostic devices
UL International UK Limited have had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices,...
