MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK regulator MHRA to raise medical device registration and other fees by...

The UK Medicines & Healthcare Products Regulatory Agency (MHRA) has published a consultation for industry comment regarding a proposed increase in fees the agency...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan’s MHLW updates medical device program display code and labeling laws

Japan’s medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code labeling laws. Manufacturers should become...

Spain – Des applis mobiles pour prédire le risque d’exacerbations de BPCO et détecter...

BARCELONE (TICpharma) - Des applications mobiles utilisant l'intelligence artificielle (IA) apparaissent comme des outils d'aide à la prédiction des exacerbations de bronchopneumopathie obstructive chronique...

France – Comment la médecine in silico peut accélérer l’innovation en matière de DM

La complexité des dispositifs médicaux modernes croît avec l'amélioration de leurs fonctionnalités, qui représentent un bénéfice pour les patients, mais augmentent également les risques...

France – Comment apporter une preuve clinique suffisante pour se conformer au RDM ?

Le Règlement 2017/745 (RDM) a considérablement augmenté la place des données cliniques dans le processus de certification des Dispositifs Médicaux (DM), en comparaison des...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions...

Article 110(2) and 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) state that devices which are covered by valid certificates...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – ANVISA announces major medical device registration updates

Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve...

USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms

The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...

USA – FDA drafts guidance on device production and quality system software assurance

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical...

Europe – New European Manual on Borderline and Classification for medical devices and IVDs...

Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of...

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