BerlinCert is now a notified body for the Medical Device Regulation (MDR)

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Good news! After a long procedure, BerlinCert is finally listed on NANDO as a Notified Body for the European Regulation 2017/745 ("Medical Device Regulation - MDR").

You will find our scope directly there. Of course, BerlinCert will maintain its competences in the future:

  • Our core competence is still in the field of active products, especially software.
  • In the area of software, we now offer certification combined with DIN EN ISO/IEC 27001 and penetration testing, so that we can offer a complete package to DiGA manufacturers.
  • We offer our services for product classes Ir, Im, IIa, IIb and III, excluding products covered by regulation 12 of Annex VIII of the MDR.
  • We are still not active in the implantable, device and injectable sectors - we have separated from the sterile products sector in order to refine our profile.

You can also find more information on our information page about the Medical Device Regulation (MDR), which is currently only available in German.

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