Europe – 3EC International becomes seventh Notified Body designated under EU IVDR
3EC International becomes seventh Notified Body designated under EU IVDR...
Europe – IVDR implementation day overshadowed by lack of notified bodies, risks to patients
While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not...
Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private...
The Australian Therapeutic Goods Administration (TGA) updated several regulations, including medical devices and in vitro diagnostic (IVD) devices under Australian legislation. Changes involve clinical...
India – Indian regulators add to list of medical device testing laboratories
Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of...
South Korea – South Korea rules on emergency production and distribution of medical products
Regulators in South Korea have introduced policies and procedures ordering the production and distribution of medical products during a public health emergency (PHE).
The Ministry...
France – Intelligence Artificielle et DM : le brouillard des règles à appliquer
Depuis plusieurs années, l’intelligence artificielle se répand rapidement dans les solutions proposées par les fabricants de dispositifs médicaux et de dispositifs de diagnostic in vitro,...
Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745...
Europe – Votre avis sur l’extension de la période de transition des RDM et...
La Commission européenne va soumettre au Parlement européen et au Conseil une proposition d'amendement modifiant les règlements (UE) 2017/745 (RDM) et (UE) 2017/746 (RDMDIV) en ce...
Europe – Questions and Answers: Commission proposes an extension of the transitional periods for...
The EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the...
USA – The biggest misconception regulatory professionals have about the FDA 510(k) program, according...
The 510(k) program is the most common pathway through which medical devices make their way to market in the US.
For devices that can demonstrate...
