Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

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...
No Shortcuts: Building Out the Right Processes to Ensure Medical Device Safety and Security

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...
WHO drafts guidance for pharma supply chain tracking

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...
Coronavirus delays many FDA foreign inspections

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...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

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...
EU Advances SPC Waiver Proposal

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...
Modalités de dépôt d'un dossier de demande d'évaluation d'acte professionnel

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...
La HAS accorde le Forfait Innovation au système WISE CRT, dispositif médical implantable de resynchronisation cardiaque

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....

NOS PROCHAINES FORMATIONS