What Is Technical Documentation?
Technical documentation is the comprehensive body of evidence that demonstrates a medical device meets the General Safety and Performance Requirements (GSPRs) set out in Annex I of the EU Medical Device Regulation (MDR) 2017/745. It serves as the primary record of the device's design, manufacturing, performance, and safety profile, and is subject to review by a Notified Body during the conformity assessment process.
MDR Annexes II and III define the structure and content requirements for technical documentation. For all devices requiring Notified Body involvement — Class IIa, IIb, and Class III — the technical documentation must be complete, current, and available for assessment at any time.
Technical Documentation Requirements Under MDR
The technical documentation must include the following elements, as defined in MDR Annex II:
Device Description and Specification
- Product or trade name, general description, and intended purpose
- Device variants and accessories covered by the documentation
- Principle of operation, mode of action, and functional elements
- Materials, components, and raw materials in contact with the patient or user
- Technical specifications including dimensions, performance attributes, and software specifications
Design and Manufacturing Information
- Complete design history file, including design inputs, outputs, verification, and validation records
- Manufacturing process descriptions and process validation data
- Identification of manufacturing sites and key suppliers
- Information on sterilization processes and validation (where applicable)
General Safety and Performance Requirements (GSPR)
- A checklist mapping each applicable requirement of Annex I to the corresponding evidence within the documentation
- Identification of harmonized standards and common specifications applied
- Justification for any requirements deemed not applicable
Risk–Benefit Analysis and Risk Management
- Risk management file in accordance with ISO 14971, including hazard identification, risk estimation, risk evaluation, and residual risk assessment
- Overall risk–benefit determination demonstrating that residual risks are acceptable when weighed against the intended benefits
Clinical Evaluation
- Clinical evaluation report (CER) per Article 61 and Annex XIV, Part A
- Clinical investigation data (where applicable), including clinical investigation plans and reports
- Post-market clinical follow-up (PMCF) plan and evaluation report
- Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices
Labeling and Instructions for Use
- Device labels in all required languages
- Instructions for use (IFU), including safety warnings and contraindications
- Information to be supplied with the device per Annex I, Chapter III
Post-Market Surveillance Documentation
MDR Annex III requires manufacturers to maintain technical documentation on post-market surveillance, including:
- Post-market surveillance plan outlining data collection methods and sources
- Post-market surveillance report (for Class I) or periodic safety update report (PSUR for higher classes)
- PMCF plan and PMCF evaluation report
- Vigilance and incident reporting records
- Trend reporting analysis
The Technical Documentation Review Process
- Submission: The manufacturer submits the complete technical documentation to Udem Atlantic as part of the conformity assessment application.
- Completeness Check: Our assessment team performs an initial review to verify that all required sections and documents are present and properly organized.
- Detailed Assessment: Technical assessors evaluate the documentation against the applicable GSPRs, reviewing the clinical evaluation, risk management file, design verification and validation data, and all supporting evidence.
- Clarification and Deficiency Resolution: If deficiencies or gaps are identified, a formal request for clarification or additional information is issued to the manufacturer. The manufacturer must address all identified items before the assessment can proceed.
- Assessment Report: A technical documentation assessment report is prepared, documenting the findings, conclusions, and any conditions or recommendations.
- Ongoing Updates: Technical documentation is a living set of records. Manufacturers must update it to reflect design changes, new clinical data, and post-market surveillance findings. Udem Atlantic reviews updates during surveillance activities.
Common Documentation Deficiencies
Based on our assessment experience, common areas where technical documentation deficiencies are identified include:
- Incomplete or outdated clinical evaluation reports
- Insufficient justification for equivalence claims
- Missing or inadequate biocompatibility evaluation per ISO 10993
- Incomplete GSPR checklist or missing traceability to supporting evidence
- Inadequate software validation documentation for devices incorporating software
- Gaps in risk management, particularly post-production risk review
Manufacturers are encouraged to conduct an internal review of their technical documentation against MDR Annex II and III requirements before submitting for conformity assessment. For questions about documentation requirements, contact Udem Atlantic.