What is Technical Documentation under MDR and IVDR?
Technical documentation is a structured set of information prepared by the manufacturer to demonstrate that a medical device or IVD meets the essential requirements outlined in Annex I of the MDR and IVDR. It is the basis for CE marking and for placing the product legally on the EU market.
Scope of Technical Documentation According to MDR and IVDR
Annexes II and III of the MDR/IVDR require inclusion of a general product description, classification, technical specifications (including Basic UDI-DI), design and manufacturing data, risk analysis (in line with ISO 14971), results of clinical or performance evaluation, a PMS plan, and the EU Declaration of Conformity.
Elements of Technical Documentation
- Device description and intended use
- Design and manufacturing data
- Quality system and production processes
- Risk analysis in compliance with ISO 14971
- Clinical/performance evaluation report (CER or PER)
- PMS plan and related reports (PSUR, PMCF, PMPF)
- EU Declaration of Conformity
Process of Developing Technical Documentation
- Product classification (under MDR or IVDR)
- Description of function, intended use, and target population
- Design and description of the manufacturing process
- Risk management process
- Clinical or performance evaluation
- Verification and validation (including preclinical testing)
- Preparation of labeling, IFU, and user information
- Development of PMS and update plan
- Drafting the EU Declaration of Conformity and choosing a notified body
The Role of Notified Body in Document Assessment
The notified body assesses whether the technical documentation complies with MDR/IVDR, including clinical data, risk management, PMS, and labeling. It may request clarifications, additional tests, or data prior to issuing the CE certificate.
Verification of Clinical Data
- Compliance with Article 61 MDR and Annex XIV
- Completeness and quality of the data
- Sources of clinical data (clinical trials, literature, benchmark devices)
- Benefit-risk analysis
- Comparative analysis with equivalent devices
Risk Management in Technical Documentation
- Risk analysis across the entire product lifecycle
- Implementation of control measures
- Assessment of residual risks
- Integration with clinical data, labeling, and specifications
Common Nonconformities and Corrective Actions
Typical issues include missing clinical data, incomplete specifications, inconsistencies in PMS plans, and labeling errors. Manufacturers must initiate CAPA and resubmit the updated documentation for review.
How Pure Clinical Supports Technical Documentation Preparation
Pure Clinical offers end-to-end support in:
- Preparing technical documentation in compliance with MDR/IVDR
- Conducting audits against ISO 13485 and ISO 14971
- Developing PMS, PMCF, and PMPF strategies
- Liaising with notified bodies for document assessment
We ensure ongoing alignment with EU regulatory updates and MDCG guidelines.
FAQ
Who is responsible for storing the technical documentation if the manufacturer is based outside the EU?
Does every change to the device require an update of the technical documentation?
How long must the technical documentation be stored?
For most devices, technical documentation must be retained for 10 years after the last device was placed on the market. For implantable devices, the minimum retention period is 15 years, as required by MDR.
What are the penalties for not having technical documentation?
What documents are included in technical documentation?
How does the technical documentation differ for MD and IVD devices?
For medical devices (MD), clinical evaluation (CER) is essential. For in vitro diagnostic devices (IVD), the focus is on the performance evaluation plan and report (PEP and PER) and supporting data from analytical and clinical performance studies.