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 – NICE recommends AI technologies for radiotherapy treatment planning
The recommendation aims to speed up the time taken to produce outlines of healthy organs, in order to help target cancer cells while avoiding...
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...
Europe – MDR/IVDR survey shows NBs have increased capacity
A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In...
UK – Implementation of medical devices future regime
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
UK – Software and Artificial Intelligence (AI) as a Medical Device
Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices...
Europe – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607...
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional
provisions for certain...
Europe – European Commission approves updated regulation to ease contact lens UDI requirements
The European Commission has agreed to amend the EU Medical Device Regulation (MDR) to ease the Unique Device Identifier (UDI) requirements for certain products,...
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 – Add 1 – MDCG Position Paper on the application of Art.97 MDR...
The position paper MDCG 2022-18 was published in December 2022 to provide a
uniform approach to the application of Article 97 of Regulation (EU) 2017/745...
