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...
UK – Medical devices: UK approved bodies
UK approved bodies for medical devices...
Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body...
The MDCG recognises that significant and urgent challenges remain in ensuring sufficient
capacity of notified bodies and readiness of manufacturers in order to allow medical...
Europe – New study shows pioneering test for endometrial cancer could significantly reduce diagnosis...
The pioneering tests, developed by researchers at the University of Innsbruck in Austria and University College London, could mean a significant reduction in the...
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 – 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 – New European MDCG guidance clarifies designation of Notified Bodies under MDR, IVDR
The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance covering designation, re-assessment and notification of Notified Bodies (NBs) as well as...
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 – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed...
Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)...
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,...
