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.
Medical device manufacturers can apply to the Joint Federal Committee (G-BA) for the NUB and receive advice on the procedure. Rules of Procedure of the G-BA.
(April 22) Distinction between medical devices and medicinal products: Guidance document MDCG 2022 of the Medical Devices Coordination Group
Internet platform for medical needs in Ukraine by the German initiative Medical Bridge.eu
(May 22) 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
(August 22) 32 Notified Bodies are now accredited. Currently there are 8 in Italy, 2 in Finland, 3 in the Netherlands and 8 in Germany; in addition, one each in Belgium, Slovakia, Hungary, Norway, France, Sweden, Slovenia, Spain (July 22), Ireland, Poland and Croatia. Nando database; see also MTD
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
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.
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
