Full MDR Support
- MDD – MDR Gap Analysis
- MDD – MDR Transition strategy
- Preparation of MDR Technical Documentation (TD):
- Design documentatioמ
- PMS Plan & Report (or PSUR)
- PMCF Plan (may include customer survey) & Report
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Systematic Literature Plan & Report
- Acting as a Person Responsible for Regulatory Compliance (PRRC)
TD Structure
The TD requirements are organized into seven main sections:
- Device description and specification
- Labeling and instruction for use
- Design and Production
- GSPRs – General Safety and Performance Requirements
- Risk Management
- Verification and Validation (includes Clinical Evaluation)
- PMS and PMCF
You should include only updated comprehensive reports and data.
Questions & Answers:
Question: How should my Technical Documentation (TD) look like?
Answer: TD should be organized (structured), consistent (throughout TD and with application forms), and searchable.
Question: How detailed should TD be?
Answer: The TD should be sufficiently detailed to allow a subject expert who does not explicitly know your device to evaluate its conformity with requirements.
Recommended guidance: TD – Best Practice Guidance (April 2023). See also NBs’ recommended TD templates.
Question: What are NB’s most common reasons for delayed TD reviews?
Answer: The most common reasons for delays in TD are due to:
- Incomplete Submissions – Insufficient or missing information not provided that is required for the conformity assessment activities. This includes an incomplete or inconsistent description of devices covered by the application and the related TD (variants, accessories, and combined devices covered by the Basic UDI-DI to be assessed).
- Lack of Cohesive Structure of Technical Documentation – The information is presented within the TD but is challenging to locate.