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:
Accreditation EN ISO 13485:2021
Application for inspection of manufactured products according to annex IV.6 of Directive 98/79/EC
Clinical Evaluation (medical devices) – Structure and contents
Data protection information for customers and interested parties
Designation_IVDR
Designation_MDR
General Rules for Certification Procedures
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/745
General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/746
General Terms And Conditions – Seminars
General Terms of Business
Guideline for the submission of electronic instructions for use
Guidelines for digital submissions
Information electronic signature
List of critical suppliers / OEM-Manufacturers (DIR, standards)
List of forged certificates / Liste Zertifikatsfälschungen
List of In Vitro Diagnostic Medical Devices (IVDR)
List of Medical Devices (MDR)
List of products – In-vitro Diagnostic Devices (CE 0483)
List of products – medical devices (CE 0483)
Notification of Change (MDR)
Notification of Change (Regulation (EU) 2017/746)
Notification of Changes (MDD/IVDD)
Notification of Changes (QM Standards)
Power of Attorney/Vollmacht
Price List – Certification according to Regulation (EU) 2017/745 (MDR) & Recognition in Third Countries
Price List – Certification according to EC Directive 98/79/EC (IVDD)
Price List (Certification according to IVDR)
Price List (Certification According to QM Standards)
Privacy information for job application
Privacy information mss 2.0
Privacy policy for IT-supported audio-/video conferences
Process Description “Technical Cooperation Programme” (TCP) – Taiwan
Process Description Certification of Quality Systems
Process Description Cooperation Procedure for Approvals in Ukraine
Questionnaire for a quotation – In-vitro Diagnostic Devices
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)
Questionnaire MDSAP (Basic Data) – DQS
Questionnaire MDSAP (Basic Data) – Guidance: How to comlete
Rules for certification procedures according to Regulation (EU) 2017/745
Rules for certification procedures according to Regulation (EU) 2017/746
Specific Regulations for Certification Processes according to MDD 93/42/EEC and IVDD 98/79/EC
Structure of Technical Documentation (Medical Devices)
Technical Documentation (In-vitro Diagnostic Devices)
Technical Documentation (In-vitro Diagnostic Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)
Use of Certification, Certificate and Certification Mark
We are happy to help you
Can’t find what you’re looking for?
Current seminar programme
SEMINARS AT MDC
Open vacancies
CAREER AT MDC