Europe – 37 ème organisme notifié au titre du Règlement 2017/745
37 ème organisme notifié au titre du Règlement 2017/745
Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical...
Europe – TUV NORD Polska New Notified Body Designated Under MDR
Notification of a Body in the framework of a technical harmonization directive...
Europe – Expert decision and opinion in the context of the Clinical Evaluation Consultation...
This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The...
Europe – MDCG 2022-17 – MDCG position paper on ‘hybrid audits’
This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745...
Europe – European Regulators Move to Increase Notified Body Capacity
The European Commission (EC) has taken new measures to relieve some of the pressure on Notified Bodies and free up capacity to perform medical...
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 – Intellectual property: harmonised EU patent rules boost innovation, investment and competitiveness in...
Today, the Commission has proposed new rules to help companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new...
