Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – 34ème Organisme Notifié

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MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Guidance : Software and AI as a Medical Device Change Programme

Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care....

Europe – European Commission Publishes Directive on the Liability of Artificial Intelligence Systems

On September 28, 2022, the European Commission published its long-promised proposal for an AI Liability Directive.  The draft Directive is intended to complement the...

UK – MHRA and NICE awarded £1.8m to explore regulation of digital mental health...

The healthcare sector has seen a considerable increase in the number of digital mental health tools made available in recent years. Despite this improvement...

Europe – Cyber Security

The increasing number of connected medical devices and ongoing digitisation in healthcare brings new market opportunities for the manufacturer and, more importantly, improvements in patient...

Europe – Data generated from ‘Off-Label’ Use of a device under the EU Medical...

‘Off label use’ is mentioned within the Medical Device Regulation (MDR) in Annex XIV Part B, in the context that manufacturers should proactively identify...
TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...

This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...

Europe – « Le risque d’une pénurie de dispositifs médicaux fait craindre une nouvelle...

Alors que la crise du Covid-19 n’est toujours pas terminée, gardons à l’esprit la première leçon qu’elle nous a apprise : l’anticipation est la clé...
TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – Notified bodies’ paper on the application of hybrid audits to quality management...

Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – MHRA appoints first new UK Approved Body to certify medical devices since...

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies,...

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