Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
UK – New device launched for diagnosing prostate cancer
CamPROBE may save vital time and money while reducing the risk of infection
November will witness the launch of a new device that is set...
Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...
UK – MHRA : Implementation of the Future Regulations
The future Medical Device Regulations is a substantial reform of the current framework as outlined in the government response. The government is committed to...
UK – Implementation of the future regulation of medical devices and extension of standstill...
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
Europe – COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down common specifications for the groups...
This Regulation lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.
Annex...
Europe – IA: la Commission européenne renforce l’exigence de garantie humaine
PARIS (TICpharma) - Le futur règlement européen sur l'intelligence artificielle (IA) devrait être finalisé "début 2023", signant le "top chrono" pour la mise en...
Europe – 34ème Organisme Notifié
ENTE CERTIFICAZIONE MACCHINE SRL
Via Ca’ Bella, 243/A - loc. Castello di Serravalle
40053 Valsamoggia (BO)
Country : Italy
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...
