Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA warns of unsafe counterfeit anti-choking devices

The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not...
Vers une plus grande coopération des pharmacopées mondiales

Europe – Recent ECJ ruling could lead to standards development tumult

Earlier this month, the European Court of Justice (ECJ) ruled there is “an overriding public interest” for the European Commission (Commission) to disclose harmonized...

Europe – Euro Roundup: European Commission proposes streamlining regulations to boost biomanufacturing

The European Commission is set to assess how to streamline regulatory pathways for the biotechnology and biomanufacturing sector as part of a broader push...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for...

When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the...

Europe – New Notified Body Designated Under EU MDR

RISE Medical Notified Body AB Sweden
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Normes Harmonisées 2024/817

La décision d’éxecution (EU) 2024/817 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives à la stérilisation des produits de...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Normes Harmonisées 2024/815

La décision d’exécution (EU) 2024/815 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives aux gants médicaux non réutilisables, à...
Advice for Management of Clinical trials in relation to Coronavirus

UK – New action to tackle ethnic and other biases in medical devices

Plan comes in response to independent report identifying the extent and impact of ethnic and other biases in the design and use of...

Europe – LNE-GMED UK désigné dans le cadre de la réglementation britannique relative aux...

En décembre 2023, LNE-GMED UK, filiale GMED du groupe LNE a été accrédité par UKAS (United Kingdom Accreditation Service) au titre de la norme...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

Uk – UK approved bodies launch Team-AB as MHRA gears up for new medtech...

Approved bodies (AB) in the UK have come together to launch the UK Association for Medical Device Approved Bodies (Team-AB). It plans to lobby...

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