Our
downloads
Service
We have compiled a large number of relevant documents for you in our download area. You have the option of searching by file name:
Or start your search with the help of predefined tags.
Use the tags to define your search:
Application for an opinion according to Regulation (EU) 2017/745 Article 117
Clinical Evaluation (medical devices) – Structure and contents
Designation_MDR
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/745
Guideline for the submission of electronic instructions for use
List of Medical Devices (MDR)
Notification of Change (MDR)
Price List – Certification according to Regulation (EU) 2017/745 (MDR) & Recognition in Third Countries
Process Description for an opinion according to MDR Article 117
Questionnaire for a quotation – Medical devices
Questionnaire for a quotation – Medical devices – Appendix II: Questionnaire Medical Devices class Ir (if applicable)
Questionnaire for a Quotation (Opinion under Regulation (EU) 2017/745 Article 117)
Questionnaire for a Quotation (QM Standards)
Rules for certification procedures according to Regulation (EU) 2017/745
Structure of Technical Documentation (Medical Devices)
Summary of changes according to Annex VII 4.11 (MDR/IVDR)
Technical Documentation (Medical Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)
We are happy to help you
Can’t find what you’re looking for?
Upcoming events
EVENTS BY MDC
Our LinkedIn profile
NEWS
Open vacancies
CAREER AT MDC