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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

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 eIFU

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 (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

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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