Downloads

Here you will find the General Terms and Conditions, the certification regulations, brochures and other publications from Berlin Cert GmbH:

• General Terms and Conditions
• Certification Regulations
• Special Terms and Conditions for Penetration Tests
• List of Fees

• Certification System Short Questionnaire
• Short Questionnaire Product Details
• MDR application review checklist
• Evaluation of a Technical File
• Änderungsmeldung/ Change of Notification
• code of conduct
• Complaint and appeal management (German only)

BfArM: Federal Institute for Drugs and Medical Devices

DIN:German Institute for Standardization

DIN Media: DIN Media

ISO: International Organisation for Standardization

Paul Ehrlich Institute: Federal Institute for Vaccines and Biomedicines

ZLG: Central Office of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices

IG-NB: Association of Notified Bodies

CEN:The European Committee for Standardization

EU Comission: Medical Devices - Sector

EU Regulations

• Access to the list of harmonised standards
• 2017: EU-Regulation on Medical Devices

Laws

• MPDG (Act on the Implementation of Union Regulations on Medical Devices)
• MPAV (Medical Device Operators Ordinance)
• MPAMIV (Regulation on the reporting of suspected serious incidents involving medical devices and on the exchange of information between competent authorities)
• MDCGs (MDCG endorsed documents and other guidance)