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 – MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under...
Article 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), asamended by Regulation (EU) 2022/1121, states that under certain conditions the...
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...
Europe – Update – MDCG 2020-16 Rev.2 – Guidance on Classification Rules for in...
This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations.
This...
Europe – IVDR Watch: European regulators add ISO 14971 to harmonized standards list
European regulators just updated the harmonized standards list for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) days ahead of its implementation date on May...
