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DrDeppe

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DrDeppe MDR-certification MDR Piktogramm englisch

Laboratorium Dr. Deppe GmbH has been successfully certified in accordance with the MDR [Regulation (EU) 2017/745]. The certificate was issued by the notified body TÜV Nord.

This was preceded by a new conformity assessment procedure in accordance with the new European Medical Devices Regulation, in which DrDeppe not only had to prove the conformity of its QM system in two on-site audits, but also that of the medical devices of risk classes IIa (surface disinfectants) and IIb (instrument disinfectants) in an evaluation of the technical documentation to the notified body.

Medical Device Regulation (MDR)
Regulation (EU) 2017/745 has replaced the Medical Device Directive 93/42/EEC. With the aim of increasing the safety of patients of medical devices, stricter requirements for the content of the technical documentation, for example, as well as obligations of the manufacturer for the QM system, risk management or the requirement for persons in the company with the necessary specialist knowledge have been expanded.

By issuing the MDR certificate, DrDeppe is now in a position to supply its customers with MDR compliant medical devices and to make new innovations and product developments available on the market.