Europe – Commission Européenne 25ème organisme notifié au Titre du Règlement (UE) 2017/745
SGS Belguim NV est le 25ème organisme notifié au Titre du Règlement (UE) 2017/745...
Europe – Arrêté du 4 mars 2022 fixant la charte de qualité des pratiques...
La charte de qualité des pratiques professionnelles des personnes chargées de la présentation, de l'information ou de la promotion des dispositifs médicaux à usage...
Switzerland – Switzerland joins EU in bringing in new IVD requirements to improve patient...
The new ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland, bringing in stricter requirements for conformity assessment and...
Europe – Best Practice Guidance for the Submission of Technical Documentation under Annex...
This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual...
Europe – The designation of notified bodies under the upcoming Artificial Intelligence Act
Artificial Intelligence (AI) algorithms, in its various forms, machine learning, deep learning, etc., implemented as embedded software (SW) or standalone SW, are gaining in...
Europe – GUIDANCE on the content and structure of the summary of the...
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of...
Europe – EU IVDR Readiness Assessment Checklist
Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)?
Under the IVDR, in vitro diagnostic (IVD) device CE Marking...
Europe – Commission seeks 5-year extension MDR/IVDR delegated acts powers
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices 1 and Regulation (EU) 2017/746 of the European Parliament and of the Council on in...
UK – What will the UK MHRA consultation bring in terms of medical device...
Over the past months, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on the current UK Medical Devices Regulations 2002. For those familiar...
Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...
