Europe – Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device...
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002...
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...
UK – Borderline products: how to tell if your product is a medical device...
Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal...
Europe – La prolongation de la période de transition pour les dispositifs médicaux et...
L’amendement qui modifie les Règlements (UE) 2017/745 et (UE) 2017/746 en ce qui concerne les dispositions transitoires relatives à certains dispositifs médicaux (DM) et...
Europe – MDCG 2024-10 Clinical evaluation of orphan medical devices
The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased...
UK – MHRA appoints first new UK Approved Body to certify medical devices since...
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...
Switzerland – Swiss Regulators Set To Recognize US FDA-Cleared or Approved Medical Devices
Swiss legislators have authorized adoption of new laws to recognize medical devices and in vitro diagnostic (IVD) devices that have received US Food and...
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....
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...
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,...
