The European Commission published the document "MDCG 2019-16 Guidance on Cybersecurity for medical devices" on January 7, 2020

The European Commission submitted the proposal for the 2nd corrigendum to the MDR to the European Parliament, which was published in the Official Journal on 27.12.2019. What this means can be found in this article.

Berlin Cert’s proposal: personal visit at your stand at the Medica

Central electronic database contains information on manufacturers, Notified Bodies, clinical trials, certificates and market surveillance

Software for the prediction or prognosis of diseases continues to count as a medical product in the sense of MDR.

Our accreditation certificate for DIN EN ISO 13485:2016 is now available in the download area!

In Europe, the introduction of the Medical Device Regulation (MDR) will make a UDI system mandatory for all manufacturers of medical devices. The transition period ends on 26.05.2020.

Time's running out! The Medical Device Regulation (MDR) was published in May 2017 and will replace Directive 93/42/EEC and Directive 90/385/EEC.

Cooperation in the field of medical technology opens up new perspectives

Accreditation certificate

Berlin Cert ist now part of GUTcert