EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of representatives of all the EU Member States, issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation...
Europe
MHRA Guidance on Medicines and Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing medicines and medical devices in controversial...
Europe
One of the most significant steps made in 2019 in Montenegro surrounding the medical device regulatory framework was the adoption of the Law on Medical Devices. This established general principles related to manufacturing, distributing and supervising medical devices...
Europe
The Medical Device Coordination Group (MDCG), the advisory body that consults the European Commission on the implementation of laws surrounding medical device circulation, issued guidance related to a new codification system to be used under the framework established...
Europe
HDR UK will release seven new health data hubs, providing over 100 doctors, scientists, and researchers with the medical histories of millions of NHS patients. They aim to aid research for new medicines, treatments, and technologies across the country, HDR’s...
Europe
Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation. However, there are slight differences in the regulatory...
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