News

MDCG 2016-16 on Cybersecurity published

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

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MDR: Corrigendum 2

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.

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Looking for a certification body or notified body?

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

Read more … Looking for a certification body or notified body?

EUDAMED - The database in the sense of the MDR

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

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Software classification in the sense of Medical Device Regulation (MDR)

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

Read more … Software classification in the sense of Medical Device Regulation (MDR)

Accreditation certificate DIN EN ISO 13485:2016

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

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UDI - Unique Device Identification

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.

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Important deadlines for MDR conversion at a glance

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.

Read more … Important deadlines for MDR conversion at a glance

Berlin Cert - Product range expanded

Cooperation in the field of medical technology opens up new perspectives

Read more … Berlin Cert - Product range expanded

Accreditation certificate

Accreditation certificate

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Berlin Cert ist now part of GUTcert

Berlin Cert ist now part of GUTcert

Read more … Berlin Cert ist now part of GUTcert