Europe – 38ème organisme notifié au titre du Règlement 2017/745
38ème organisme notifié au titre du Règlement 2017/745
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 – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition...
Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR...
Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is...
UK – Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the...
MHRA is aware of a very small number of cases of squamous cell carcinoma (SCC) and different types of lymphoma, found within the fibrous capsule...
UK – Borderline products: how to tell if your product is a medical device...
Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal...
Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro...
In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices...
Europe – Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Nouveau Organisme notifié au titre du Règlement (UE) 2017/745
Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations...
In the case of implantable devices and class III devices, clinical investigations shall be
performed, except if:
— the device has been designed by modifications of...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
