Tag: MDR

“The tables have turned”—US FDA regulation is becoming the envy of...

Discussions at this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) revealed the extent of the disparities between the...

European Society for Brain Stimulation “strongly opposes” reclassification of non-invasive devices

The European Society for Brain Stimulation (ESBS) has said it “strongly opposes” the European Union’s (EU) recent decision to reclassify non-invasive brain stimulation (NIBS)...

EU ministers approve changes to MDR transition timetable

The European Union’s (EU) Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the...

Swiss parliament votes to accept US FDA-approved medical devices

The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland. A motion...
vesalio

Vesalio announces EU MDR certification of neurovascular product lines

Vesalio has announced EU Medical Device Regulation (MDR) certification of its product lines—achieving this “significantly ahead” of its May 2023 deadline, according to a...

COVID-19: European Commission agrees to postpone new MDR because of pandemic

The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which...

COVID-19: European Commission looking to postpone new MDR by one year

During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to...