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
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.
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
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!
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.
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
new certificate of recognition of our testing lab
new certificate of recognition of our testing lab
Read more … new certificate of recognition of our testing lab