CE APPROVAL PROCESSCE MARK CONSULTANTSMDR TECHNICAL FILE TYPESMEDICAL DEVICE USABLITYMEDICAL DEVICE LABELINGCLINICAL EVALUATIONMEDICAL DEVICE SYMBOLSRISK MANAGEMENTSTABLITY STUDIESCE MARKING
The medical device technical file, as outlined in MDR 2017/745 Annex II, serves as a comprehensive document created by the manufacturer to demonstrate the performance and safety of a specific device. It should be clear, well-organized, easily searchable, and unambiguous.
Manufacturers must submit the medical device technical file to a notified body or Competent Authority for review and approval. The file should be in English or an official language of an EU Member state. The file must be accessible upon request throughout the device’s life cycle, which is five years for low-risk devices and 16 years for high-risk devices. Non-EU manufacturers must keep the file with their EU Representative. Our website can help you with Technical Files Writing.
Regardless of the medical device’s class, intended use, construction, or safety history, the manufacturer must possess and maintain up-to-date technical file documentation to demonstrate compliance with performance requirements outlined in Annex I of MDR 2017/745.
When determining the number of technical files required for products intended for European CE Marking, the QA and Regulatory consulting team members may face confusion or difficulty. The medical device Technical Files Writing pertains solely to a specific device, focusing on its safety and performance. Therefore, products with different intended uses, classes, construction materials, or designs cannot be combined within a single technical file.
Various factors must be considered when preparing a medical device’s technical file, such as the device’s intended use, an indication of use, the site of application, design changes, major constructional changes, and the state of the art.
Preparing a medical device technical file requires expertise from a team of professionals experienced in EU Medical Device CE Marking. These experts are known as consultants, covering core technical areas such as risk analysis, validations, design, shelf-life, usability, biological evaluation, safety, chemical characteristics, and clinical evaluation. At I3CGLOBAL, we have a team of experts who can be directly contacted for medical device Technical Files Writing.
To meet the requirements of CE MDR, the technical Documentation must include risk classification and identification of the assessment route for CE Marking. The files should be systematically organized, arranged, and reviewed. Additionally, clinical evaluation documentation covering PMS, PMCF, and PSUR, risk analysis, and implementing a medical device quality management system are necessary.
The type of medical device technical file may vary depending on the device’s construction.
|0||1||TECHNICAL FILE DETAILS|
|0||1.7||LEGAL NAMES AND ADDRESS OF THE MANUFACTURER|
|0||1.8||EUROPEAN UNION AUTHORIZED REPRESENTATIVE|
|1||1||DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES|
|1.1||1.1||DEVICE DESCRIPTION AND SPECIFICATION|
|1.1a||1.1.1||PRODUCT OR TRADE NAME|
|1.1c||1.1.6||THE INTENDED PATIENT POPULATION|
|1.1d||1.1.11||PRINCIPLE OF OPERATION|
|1.1e||1.1.12||MEDICAL DEVICE RATIONALE|
|1.1f||1.1.13||DEVICE CLASSIFICATION AND JUSTIFICATION|
|1.1g||1.1.14||EXPLANATION OF NOVEL FEATURES|
|1.1h||1.1.15||DESCRIPTION OF THE ACCESSORIES|
|1.1i||1.1.16||DESCRIPTION OF THE VARIANTS|
|1.1j||1.1.17||COMPONENTS DESCRIPTION WITH DRAWINGS|
|1.1k||1.1.18||DESCRIPTION OF THE RAW MATERIALS|
|1.2||1.2||REFERENCE TO PREVIOUS AND SIMILAR GENERATIONS OF THE DEVICE|
|1.2a||1.2.1||AN OVERVIEW OF THE PREVIOUS GENERATION|
|1.2b||1.2.2||AN OVERVIEW OF EQUIVALENT OR SIMILAR DEVICES|
|2||2||INFORMATION TO BE SUPPLIED BY THE MANUFACTURER|
|3||3||DESIGN AND MANUFACTURING INFORMATION|
|3a||3.1||DESCRIPTION OF THE DESIGN|
|3b||3.2||DESCRIPTION OF THE MANUFACTURING PROCESS|
|3b||3.2.2||FINAL PRODUCT SPECIFICATION AND TESTING|
|3b||3.2.3||MANUFACTURING ENVIRONMENTAL CONTROLS|
|3c||3.3||SUPPLIERS AND SUBCONTRACTORS|
|4||4||GENERAL SAFETY AND PERFORMANCE REQUIREMENTS|
|4||4.1||THE GENERAL SAFETY AND PERFORMANCE REQUIREMENTS|
|4||4.2||DECLARATION OF CONFORMITY|
|4c, 4d||4.3||LIST OF APPLICABLE LEGISLATION|
|4c, 4d||4.4||LIST OF APPLICABLE GUIDELINES|
|4c, 4d||4.5||LIST OF APPLICABLE HARMONIZED STANDARDS|
|4c, 4d||4.6||LIST OF APPLICABLE NON- HARMONIZED STANDARDS|
|5||5||BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT|
|5a||5.1||THE BENEFIT-RISK ANALYSIS|
|6||6||PRODUCT VERIFICATION AND VALIDATION|
|6.1||6.1||PRE-CLINICAL AND CLINICAL DATA|
|6.1b||6.1.2||BIOCOMPATIBILITY OF THE DEVICE|
|6.1b||6.1.3||ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY|
|6.1b||6.1.4||SOFTWARE VERIFICATION AND VALIDATION|
|6.1d||6.1.8||POST MARKET ACTIVITIES|
|6.1d,6.2e||6.1.9||PACKAGING AND TRANSPORTATION|
|6.2||6.2||ADDITIONAL INFORMATION REQUIRED IN SPECIFIC CASES|
|6.2a||6.2.1||MEDICINAL PRODUCTS WITHIN THE MEANING OF DIRECTIVE 2001/83/EC|
|6.2b||6.2.2||TISSUES OR CELLS OF ANIMAL ORIGIN|
|6.2c||6.2.3||DEVICES THAT ARE COMPOSED OF SUBSTANCES OR COMBINATIONS OF SUBSTANCES|
|6.2d||6.2.4||CMR OR ENDOCRINE-DISRUPTING ACTIVITY|
|6.2g||6.2.7||COMBINATION WITH OTHER DEVICES|
|CONCLUSION AND APPROVAL|