Medical Devices Regulations (MDR)

The new Medical Devices Regulations (MDR) – what you need to know!

the new Medical Devices Regulations (MDR), which must be fulfilled for CE certification as of May 2020
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.

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Second Notified Body TUV Sued

TUV Sued is second Notified Body after MDR

CE Mark is awarded by Notified Body
photo: IStock
CE Mark is awarded by Notified Body

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.

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MDR will cause Great Changes in medical technology

MDR will cause Great Changes

MDR (Medical Devices Regulation) will cause Great Changes
photo: iStock
MDR (Medical Devices Regulation)

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).

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