Tag: Europe Regulatory Updates

Medical Devices – USA/Europe Regulatory Updates round up Dec-2021

January 11, 2022
Medical Device

EUROPECommission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards...

Canada regulatory updates, Europe Regulatory Updates, Medical Devices, Regulatory Updates, US FDA

Medical Devices – USA/Europe Regulatory Updates round up – Oct 2021

November 5, 2021
Medical Device

EUROPE1. MDCG 2021-26 – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents questions and answers...

EU Medical Device clinical Requirements, Europe Regulatory Updates, FDA Medical Device clinical Regulations, medical device labeling requirements, Medical Devices, Regulatory Updates, USA Regulatory Updates

Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

October 6, 2021
Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

Europe, Europe FDA, Europe Medical Devices, Europe Regulatory Updates, FDA Updates, Medical quality, medicaldevice, Regulatory Updates, USA, Usa Medical Devices, USA Regulatory Updates