CE Marking Procedure
SKU: SOP 7-040
The CE Marking procedure governs the content of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with Medical Device Regulation MDR (EU) 2017/745.
- MDR EU 2017/745 Compliant
- ISO 13485:2016 Compliant
- MEDDEV 2.4.1 Compliant
- MS Word Format
- Instant Download Digital Content
CE Marking Procedure
The CE Marking Procedure provides a method to assure that all CE Marked medical devices commercialized in the Union are in compliance with the European Medical Device Regulation MDR (EU) 2017/745.
CE Marking Procedure Overview
The CE Marking Procedure provides detailed instruction on the creation, content and routine maintenance of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with the Medical Device Regulation MDR (EU) 2017/745.
CE Technical File / Design Dossier Content
The CE Technical File / Design Dossier shall be constructed as follows:
PART A: Technical Documentation / Design Dossier
1. Table of Content
3. Design Dossier/Technical Documentation Summary Information
PART B: Annexes
1. General Safety and Performance Requirements Checklist
2. Risk Analysis
3. Drawings, Design -, Product – Specifications
4. Chemical, Physical and Biological Tests
4.1 In Vitro Testing - Preclinical Studies
4.2 In Vivo Testing - Preclinical Studies
4.3 Biocompatibility Tests
4.4 Bio-stability Tests
4.5 Microbiological Safety, Animal Origin Tissue
4.6 Drug / medical device combination
4.7 Blood Derivates, Human Tissue / medical device combination
4.8 Coated Medical Devices
5. Clinical Data
6. Labels and Instructions For Use
8. Package Qualification and Shelf Life
10. Measuring Function
11. Combination with other Medical Devices
12. Compatibility to drugs
13. Other applicable directives and regulations
15. Declaration of Conformity
16. Correspondence with Notified Bodies
Clinical Evaluation and Clinical Evaluation Report (CER)
The Clinical evaluation and a clinical evaluation report shall be made part of the technical file / design dossier and shall comply with the requirements of Article 61 and Annex XIV, Part A of the MDR.
Post Market Clinical Follow Up and Report
Post Market Clinical Follow-up and a Post Market Clinical Follow-Up Report shall also be made part of the Technical File / Design Dossier and shall comply with Article 61 and Annex XIV, Part B of the MDR.
Clinical Investigations and Final Report
Clinical investigations and a clinical investigation final report shall also be made part of the Technical File / Design Dossier and shall comply with Article 61 and Annex XV of the MDR.
CE Marking Procedure Compliance
The CE Marking Procedure is ISO 13485:2016 and MDR (EU) 2017/745 compliant.
For more information about our CE Marking Procedure contact us at firstname.lastname@example.org
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