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MDR (Medical Device Regulation)

Declarations of conformity according to MDR

Since May 26, 2021, the new EU Medical Device Regulation (MDR) (EU 2017/745) is mandatory for medical device manufacturers. This replaces the Medical Device Directive (MDD) (93/42/EEC) which was valid until then.

All declarations of conformity of our medical devices have been updated by the introduction of the MDR, according to its requirements.

The declarations of conformity are available to you, as our certified customer, for download in the customer online portal.

 

EUDAMED

EUDAMED is the European database for medical devices. It serves the central administration of medical devices in the EU and is based on a resolution of the EU Commission (2010/227/EU) from the year 2010. Through the MDR (Medical Device Regulation (EU 2017/745)), we as manufacturers are obligated to provide informations about us and our products in the database.

In EUDAMED we are registered under the following Single Registration Number (SRN):  DE-MF-000016437

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