Europe – UDEM Adriatic d.o.o. New Notified Body Designated Under MDR
Notification of a Body in the framework of a technical harmonization directive...
Europe – New study shows pioneering test for endometrial cancer could significantly reduce diagnosis...
The pioneering tests, developed by researchers at the University of Innsbruck in Austria and University College London, could mean a significant reduction in the...
Europe – European Council members support proposal to delay MDR deadlines
European Council members expressed support for a proposal by the European Commission to delay the transitional deadlines for medical devices under the Medical Devices...
Europe – Publication of the Third Edition of the “Clinical Evidence Requirements under EU...
We are pleased to announce the publication of the Third Edition of the “Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation” Regulatory eBook.
The Questions and Answers eBook was developed by...
Europe – Artificial intelligence in healthcare
In recent years, the use of artificial intelligence (AI) in medicine and healthcare has been praised for the great promise it offers, but has...
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...
UK – Exceptional use of non-UKCA marked medical devices
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is...
Europe – UPDATE – MDCG 2020-3 Rev.1 – Guidance on significant changes regarding the...
Article 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR), last amended by Regulation (EU) 2023/607, states that devices which continue to comply with...
Europe – Guidance on the procedural aspects for the consultation to the European Medicines...
This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural...
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...
