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Accreditation EN ISO 13485:2021
Application for inspection of manufactured products according to annex IV.6 of Directive 98/79/EC
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_2023-01-16
Designation_MDR_2020-04-29
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 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 products – In-vitro Diagnostic Devices (CE 0483)
List of products – medical devices (CE 0483)
Notification of Change (IVDR)
Notification of Change (MDR)
Notification of Changes (MDD/IVDD)
Notification of Changes (MDD/IVDD)
Notification of Changes (QM Standards)
Power of Attorney/Vollmacht
Price List – Certification according to EC Directive 98/79/EC (IVDD)
Price List (Certification according to IVDR)
Price List (Certification according to MDR)
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 Medical Devices – Attachment: List of In Vitro Diagnostic Medical Devices (IVDR)
Questionnaire for a quotation – In-vitro Diagnostic Devices
Questionnaire for a quotation – Medical devices
Questionnaire for a quotation – Medical devices – Attachement II: Questionnaire Medical Devices class Ir (if applicable)
Questionnaire for a quotation – Medical devices – Attachment I: List of Medical Devices (MDR)
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
Technical Documentation (In-vitro Diagnostic Devices) – Contents
Technical Documentation (In-vitro Diagnostic Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – Contents
Technical Documentation (Medical Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)
Use of Certification, Certificate and Certification Mark
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