The new Medical Devices Regulations (MDR) – what you need to know!
photo: iStock CE mark according to MDR
The new Medical Devices Regulations (MDR) and the Active Implantable Medical Devices Directive (AIMDD) were published in May 2017. Its transitional period will end on 26 May 2020. From that date the MDR will apply fully.
16.06.2019 – TUV Sued Product Service has been recognised by the “Central Office of the Countries for Health Protection with regard to Pharmaceuticals and Medical Devices” (ZLG) as the second Notified Body for the new Medical Devices Regulations (MDR) after the British-Dutch BSI.
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
Swissmedic refers to a leaflet on the obligations for authorised representatives, importers and distributors
European industry association for digital assistive technology DATEurope founded in early 2021. DAT includes aids for communication, for the blind and visually impaired, for environmental control, assistive call systems, software tools and robotics.
Overview of all assessments of new examination and treatment methods (NUB) by the G-BA
28 Notified Bodies are now accredited. Currently (April 2022) there are 7 in Italy, 2 in Finland, 3 in the Netherlands and 7 in Germany; in addition, one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Ireland and Croatia. Nando database
the MHRA in the UK has published a guidance document for manufacturers and distributors of medical devices
new standalone UKCA mark after Brexit; current EU CE marking will still be in operation for Medical Devices and invitro diagnostic in Great Britain until June 2023
On 1 July 20, the Swiss Federal Council adopted the revision of the Regulation on Medical Devices (MepV) and the new Regulation on Clinical Trials for Medical Devices (KlinV-Mep). As a result, Switzerland remains subject to EU medical device law.
