Schlagwort-Archive: Medical Devices Regulations

Medical Devices Regulations (MDR)

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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
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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

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CE Mark is awarded by Notified Body
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CE Mark is awarded by Notified Body

TUV Sued is second Notified Body after MDR

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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