Technical Documentation Structure Under MDR

Technical Documentation dossier (for pre market assessment) and Post Market Surveillance (PMS) documentation. According to Article 10(4) of the MDR, for all devices except custom made, manufacturers shall provide information in the form of Technical Documentation, allowing the assessment of conformity with this Regulation of the device. This blog describes how to structure the Technical Documentation in Annex II, and the PMS part in Annex III.

Overview OF ANNEX II – Technical Documentation For The Device (Pre Market)

Annex II to the MDR specifies the information that has to be included in the Technical Documentation dossier that the manufacturer should hold. Below are the key sections (sub elements) you would need for creating your document in the right way. The numbering corresponds to the structure of the annex.

Device Description and Specification (including variants & accessories) – Annex II (section 1)

In this section, you will describe your device providing detailed information about its nature, function, variants, accessories and classification rationale. Important aspects include:

• Product/trade name, general description and intended purpose (the target population, function).

• Basic UDI-DI (or until the introduction of UDI, unique product code, catalog number or similar) allowing traceability.

• Target patient population, conditions to be diagnosed, treated or monitored, and contraindications/warnings (if any).

• The principle of operation and mode of action (scientific rationale if required).

• Rationale for qualification of the product as a medical device (i.e. reasons why it is covered by the MDR scope but not another regulation/directive).

• Risk class of the device and justification of classification rule(s) applied according to Annex VIII.

• Description of any innovative aspects.

• Description of accessories, other devices or products intended to be used in combination. 

• Description of configurations/variants offered.

• General description of key functional components (illustrated with drawings, photographs), materials in contact or indirect contact with the human body, and technical specifications (sizes, performance, etc.) of the device and its variants/accessories. 

• References to any previous and similar generations of the device (if any) and overview of similar devices available in the EU or internationally. 

Why it matters: In order to understand exactly what is going to be put on the market, how it is used and what the manufacturer's offer contains (variants, accessories) the Notified Body or Competent Authority will need this information.

Information to be Supplied by the Manufacturer Annex II (section 2)

This section covers the information provided by the manufacturer along with the device. It is:

• Final label applied to the device, packaging (unit, sales and transport), in languages of the Member States where the device is put on the market.

• Instructions for use (IFU) in all the languages required, and any user/install/service manuals.

Take away: Make sure that you have final versions of labeling and IFU and that they cover the requirements of the languages in the markets you target.

Design and Manufacturing Information Annex II (section 3)

This section gives a detailed account of how the device is designed and manufactured. It allows an external evaluator to comprehend the logic of the design, process control and manufacturing traceability. The main elements to include are:

• Information to allow reviewing the design process (inputs, outputs, traceability).

• Full information/specification including manufacturing processes and their validation, continuous monitoring and final product testing.

• Identification of all sites involved in design and manufacturing activities, subcontractors/suppliers.

Note: The documentation should be up to date and reflect the current manufacturing process; all changes (e.g. new supplier, manufacturing site change) should be reflected.

General Safety and Performance Requirements (GSPR)  Annex II (section 4)

GSPRs, which are listed in Annex I to the MDR, are the main safety and performance criteria, with which manufacturers are to ensure that their devices comply. The Technical Documentation shall contain the following information about GSPRs:

• List of all applicable GSPRs (from Annex I) along with the rationale for the unapplicable GSPRs.

• Approaches to demonstrating compliance with all applicable GSPRs (by means of testing, risk management, clinical evaluation, etc.).

• Identification of harmonized standards, common specifications (CS) or other solutions used for complying with GSPRs (with detailed identification of controlled documents).

• References to the location of the evidence in the Technical Documentation (or summary technical documentation).

Note: Compliance with GSPRs is the core of the dossier: failure to demonstrate compliance with each and every applicable GSPR may lead to delays or rejection of the dossier.

Benefit Risk Analysis and Risk Management  Annex II (section 5)

The manufacturer must demonstrate the use of a systematic approach to risk management, the assessment of benefits in comparison with residual risks and implementation of risk control measures. The information to provide in this section should be as follows:

• Documented benefit risk analysis, mentioned in sections 1 and 8 of Annex I.

• The process and result of risk management including identification, evaluation, mitigation and justification of residual risks according to section 3 of Annex I.

Tip: Connect the risk management file with the GSPR section and with clinical/verification validation evidence.

Product Verification and Validation (including Pre clinical & Clinical) Annex II (section 6)

This section should contain the evidence of compliance with the technical specifications, safety and performance requirements of the device, including pre clinical testing, usability/ergonomics testing, software validation (if applicable), sterilization, shelf life testing, clinical evaluation and clinical investigations (if applicable). Typical sub sections are as follows:

1. Pre clinical/verification testing

• Laboratory, bench, simulation or animal testing as needed.

• Materials testing, electrical/electronic safety, EMC, software life cycle, usability, sterilization/biocompatibility testing, shelf life testing.

2. Clinical Evaluation and any Clinical Investigation

• Documentation on clinical evaluation plan (CEP) and report (CER) in accordance with Article 61 and Annex XIV as needed.

• If required, clinical investigation plan and report (in accordance with Annex XV and MDR Chapter VI).

• Additional information, depending on the case (e.g., device intended for lay use, innovative devices, implantable devices).

Note: This section must demonstrate the traceability of the evidence: specification → design inputs/outputs → verification/validation → risk management → clinical evaluation. Lack of traceability is usually noted by the Notified Bodies.

Other Considerations (Lifecycle And Maintenance)

Though this section is not always numbered in Annex II, you should consider a lifecycle approach: your dossier must become a "living" one to be maintained and updated.
Also: If you are already selling your devices on the basis of older Directives, the manufacturer should demonstrate how the legacy products relate to the current documentation and how the transition to MDR is done.

Overview Of ANNEX III Technical Documentation On Post market Surveillance

Once your device is placed on the market, your duties do not end there. Annex III of the MDR prescribes you to compile and maintain documentation on post market surveillance (PMS) of your device to demonstrate its continuing safety and performance. The PMS documentation must be organized and well structured. Below are key parts you need to structure.

Post Market Surveillance Plan  Annex III (section 1)

The PMS Plan describes how you will systematically collect, analyze, evaluate and respond to post market data. The following topics shall be addressed in the PMS Plan:

• Sources of information: serious incidents (including PSURs/field safety corrective actions), non serious incidents, undesirable side effects, trend reporting, specialist literature/databases/registers, users'/distributors'/importers' feedback, public information on similar devices.

• Process: ways to collect the information mentioned above; methods and tools to assess the data collected; thresholds for the re assessment of the benefit risk balance and risk management review; methods for the investigation of complaints and trend analysis, traceability tools for the purpose of identifying the device for corrective actions, communication protocol with authorities, Notified Bodies, users.

• Integration: reference to your procedures on fulfilling your duties under Articles 83, 84 and 86 (v vigilance, corrective actions, safety measures).

• Plan for Post Market Clinical Follow Up (PMCF) or justification for absence of such PMCF (if required under Annex XIV Part B).

Practical tip: Your PMS Plan must be well aligned with your design/product file (Annex II) so that the field feedback, the incident data and the trends would be used to update your risk management, clinical evaluation and product changes.

Periodic Safety Update Report (PSUR) and PMS Report Annex III (section 2 and 3)

This Annex requires you to compile and maintain the Periodic Safety Update Reports (PSURs) summarizing your PMS results and actions taken (for the device classes IIa, IIb, III). Also, you shall have the PMS Report summarizing the results of your PMS and conclusions made.

Linkage with Other Processes

Your PMS documentation must connect with your risk management file, clinical evaluation (including PMCF if necessary), vigilance/reporting system, design change control, and regulatory update procedures. This is to ensure that post market experience gets feedback into the whole product lifecycle.

Best practices For Organising The Dossier

Here are some best practices that can be used by regulatory professionals and the manufacturer to organise the compliant dossier:

• Follow the logical table of contents and numbering scheme that matches the sections of Annex II and Annex III.

• Include cross‑references among sections (risk management section to the GSPRs section, verification/validation to the design and manufacturing).

• Include current, versioned, dated documents that reflect all changes in the device, production process or on the market.

• Give a rationale why something is not applicable (a certain GSPR, clinical investigation), do not just say “N/A”.

• Ensure that labels and IFUs translations are correct for all Member States where the product is marketed.

• Connect the post‑market surveillance data to risk management, design change management and clinical evaluation updating.

• Maintain traceability: intended use → specification → verification/validation → risk management controls → clinical evaluation → PMS data.

• Proactively cooperate with your Notified Body in advance on the following: submission format, language, file organisation, document search‑ability.

Conclusion

In conclusion, Technical Documentation (Annex II) and the Post Market Surveillance documentation (Annex III) are the core elements of your regulatory dossier. It has to be robust, structured, up to date, traceable and should demonstrate how your device meets all requirements of the MDR on safety, performance and life cycle and post market management.

By structuring your dossier using the headings above and ensuring that all items are properly covered, you are setting the ground for your regulatory compliance.