Europe – Artificial Intelligence Act : un nouveau règlement européen à suivre de près
L’AIA est une proposition de règlement du parlement et du conseil européens dévoilée le 21 avril 2021, dont l'entrée en vigueur est programmée dans...
Europe – Un nouveau organisme notifié au titre du règlement (UE) 2017/745
Body Name - HTCert (Health Technology Certification Ltd)
Address - Jacovides Tower 81-83 Grivas Digenis Avenue
1090 Nicosia
Country - Cyprus
Email- info@htcert.com
Website - www.htcert.com
Body Number - 2803
Last approval...
Europe – MDCG 2023-2 List of standard fees
Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation...
Depuis le retrait du Royaume-Uni de l’UE, l’accord entre la Suisse et l’UE relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité...
UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices...
Switzerland – New organisational structure with separate Medical Devices Surveillance Sector
For the strategy period 2023-2026, Swissmedic’s objectives include making legal responsibilities for medical devices more visible and stepping up international collaboration in this area....
USA – Medtech expert says EU’s AI Act could face an uphill political battle
If the EU is unable to pass a hotly anticipated artificial intelligence/machine learning (AI/ML) law by year’s end, it may face an uphill battle...
Europe – Notified Bodies Survey on certifications and applications (MDR/IVDR)
To support monitoring and analyzing the availability of medical devices on the EU
market in the context of the implementation of medical devices and in...
Europe – Phthalates in certain medical devices: updated SCHEER guidelines published
Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the update of their guidelines on...
