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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
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)
Rules for certification procedures according to Regulation (EU) 2017/745
Structure of Technical Documentation (Medical Devices)
Technical Documentation (Medical Devices) – File Structure (ZIP)
Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)
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