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...
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...
Europe – EMA to launch scientific advice pilot for high-risk devices in late February
The European Medicines Agency (EMA) will begin accepting volunteers for a pilot program to provide scientific advice to manufacturers of high-risk medical devices by...
