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Focus on Regulation

Tag Archives: Notified Bodies

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”). This Notice applies, among others, to medical devices, active implantable medical devices and in vitro medical devices. The Q&A

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and

ANSM on the de-notification or termination of notified bodies’ activities

On 14 November 2016, the French National Agency for Medicines and Health Products Safety (“ANSM”) issued the English version of an information bulletin and a Q&A document concerning the consequences of de-notification or termination of notified bodies’ (“NB”) activities, dated 24 October 2016. Background The ANSM notes that in recent months, several notified bodies have

The European Commission adopts stricter rules concerning notified bodies

On Tuesday 24 September 2013, the European Commission adopted a Regulation intended to strengthen the criteria for the designation and supervision of notified bodies under the Medical Devices Directives[1]. On the same day, the European Commission also adopted a Recommendation concerning the tasks to be fulfilled by notified bodies when conducting audits and conformity assessment