The new Medical Devices Regulations (MDR) – what you need to know!
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.
28.09.2018 – The MDR (Medical Devices Regulation) will cause great changes in the world of medical technology. The MDR has been adopted on the 5th April 2017 and will replace the MDD (Medical Devices Regulation) and AIMDD (Active Implantable Medical Devices Directive).
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.