Europe – Effects of “No Deal” Brexit for Medical Device Sector
EMERGO SUMMARY OF KEY POINTS:
A “no deal” or “Cliff Edge” Brexit is a realistic scenario, becoming more realistic every day.
The UK government...
International – No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety...
Regulatory focus on medical device safety and risk management intensifying;
Functions such as clinical research, post-market surveillance and ISO 14971 compliance should bolster...
International – WHO Drafts Global Strategy on Digital Health
The World Health Organization (WHO) released a newly drafted four-year global strategy on digital health, with an aim to “improve health for everyone, everywhere...
USA – FDA proposes to end quarterly reporting of medical device decisions
The US Food and Drug Administration (FDA) on Monday proposed revisions to its medical device regulations to end its practice of publishing quarterly lists...
USA – Guidance : Review and Update of Device Establishment Inspection Processes and Standards
FDA is issuing this guidance to comply with section 702(b)(2) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA...
Europe – MDCG 2020-17 : Q&A on temporary extraordinary measures related to medical device...
This document presents questions and answers on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions.
The...
Europe – MDCG 2021-13 Questions and answers on obligations and related rules for the...
This Q&A is a document aimed at addressing questions relating to the registration in
EUDAMED of actors other than manufacturers, authorised representatives and
importers subject to...
France – La HAS retoque la demande de prise en charge transitoire de la...
SAINT-DENIS (Seine-Saint-Denis) (TICpharma) - La commission nationale d'évaluation des dispositifs médicaux et des technologies de santé (Cnedimts) de la Haute autorité de santé (HAS)...
Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system...
This document presents questions and answers on the Unique Device Identification system
(UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation...
France – La HAS accorde le Forfait Innovation au système WISE CRT, dispositif médical...
Le système WISE CRT est un dispositif médical implantable de resynchronisation cardiaque délivrant une stimulation du ventricule gauche (VG) sans l’utilisation de sonde transveineuse....
