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Technical Documentation
The Technical Documentation is the set of documents that demonstrate a medical device complies with the applicable regulatory requirements.
The European Medical Device Regulation (EU) 2017/745 requires manufacturers to prepare and maintain comprehensive technical documentation that demonstrates conformity of their medical devices, ensuring the information is clear, organized, and updated throughout the product life cycle.
The Annex II and III of MDR require the following structure for the technical documentation:
1. Device Description and Specification
● Device name, model(s), intended purpose, and classification.● Reference to previous and similar generations of the device.● Description of accessories and other devices intended to be used with it.
2. Information to Be Supplied by the Manufacturer
Label(s) on the device and on its packaging
Instructions for use3. Design and Manufacturing Information
● Design documentation● Manufacturing processes and their validation● Sites and suppliers
4. General Safety and Performance Requirements (GSPR)
Table with each GSPR related to harmonized standards, CS or other solutions applied and identity of the controlled documents offering evidence of conformity.
5. Benefit-Risk Analysis and Risk Management
Risk management file according to ISO 14975 including benefit-risk balance.
6. Product Verification and Validation
● Pre-clinical data and laboratory test● Clinical data, including Clinical Evaluation and PMCF● Additional information required in specific cases
7. Post-Market Surveillance
● Post-market surveillance plan● Post-market surveillance (PMS) report or Periodic Safety Update Report (PSUR)
8. Declaration of Conformity
Declaration of Conformity according to Article 19 and Annex IV of the Regulation (EU) 2017/745.
The FDA requires manufacturers to comply with the Quality System Regulation (QSR, 21 CFR Part 820).
Key documentation requirements include:
1. Design History File (DHF)
Required under 21 CFR 820.30(j).Must contain all records showing that the device was developed according to the approved design control process.Includes design inputs, design outputs, verification, validation, risk management file, usability engineering file, design reviews, and design transfer records.
2. Device Master Record (DMR)
Required under 21 CFR 820.181.Describes how to manufacture the device: specifications, drawings, bill of materials, manufacturing instructions, formulations, production processes, quality assurance procedures, packaging, and labeling.
3. Device History Record (DHR)
Required under 21 CFR 820.184.
Contains the actual production history for each device lot or unit manufactured, proving it was made in accordance with the DMR.