Europe – European Medical Device Nomenclature (EMDN) : Q & A
Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices...
Europe – Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’...
Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it...
Europe – IVDR: MDCG charts rollout in new implementation plan
The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR)...
Europe – IVDR : la date d’application sera-t-elle repoussée ?
Representing cancer patients, diagnostic and laboratory industry experts and the pharmaceutical industry, we write to you with serious concerns related to the unaddressed implementation...
Europe – May’s Regulatory Focus: EU MDR and EU IVDR update, and more
Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline...
Europe – MDCG 2021-11 Guidance on Implant Card – ‘Device types’
According to Article 18 (a) of the MDR, the manufacturer of an implantable medical device
shall provide together with the device, information allowing the identification...
Europe – IVD devices: From performance evaluation studies to clinical performance studies, what has...
For the marketing of in vitro diagnostic (IVD) medical devices manufacturers need to demonstrate that their products perform as claimed, which typically requires performance...
UK – Using the UKCA marking
The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England,...
Europe – MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN)
Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23
of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR),...
Europe – MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under...
The MDCG hereby endorses the principles laid out under Appendixes E - I of the IMDRF
N48 guidance document, as published on 21 March 2019...
