Introduction

Technical Documentation dossier (for pre‑market assessment) and Post‑Market Surveillance (PMS) documentation. Article 10(4) of the MDR requires that, for all devices except custom‑made, manufacturers must prepare documentation such that the conformity of the device with the regulation can be assessed. This blog breaks down how you structure the Technical Documentation under Annex II, and the PMS or Post‑Market part under Annex III, so you understand what to include and how to organise it.

Overview Of Annex II – Technical Documentation For The Device (Pre‑Market)

Annex II of the MDR lays out the detailed information that must be contained in the Technical Documentation dossier that a manufacturer must maintain. Below are the major headings (with sub‑elements) you will commonly use when structuring your file. The numbering mirrors the Annex layout.

Device Description And Specification (Incl. Variants & Accessories) – Annex II (Section 1)

This section introduces what the device is, clarifying its identity, purpose, variants, accessories, and classification rationale. Key elements include:

• The product/trade name, a general description, the intended purpose (who it is for, what it does).

• The Basic UDI‑DI (or until UDI implementation, a unique product code, catalogue number or similar) to allow traceability.

• The intended patient population, medical condition(s) to be diagnosed/treated/monitored, and related contraindications or warnings.

• The principles of operation and mode of action (scientific justification if needed).

• ationale for qualification of the product as a medical device (i.e., how it falls under the MDR scope rather than another regulation or directive).

• The risk class of the device and justification of classification rule(s) applied per Annex VIII.

• Explanation of any novel features.

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

• Description of configurations/variants offered.

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

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

Why this matters: A Notified Body or Competent Authority must be able to understand exactly what is being placed on the market, how it is used, and what the manufacturer’s offer includes (variants, accessories). This foundational section sets up the rest of the dossier.

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

This section covers what the manufacturer provides with the device. It includes:

• Final labels applied to the device, packaging (unit, sale, transport), including languages of the Member States where the device is placed on the market. 

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

Take‑away: Ensure your labeling and IFU are final versions, reflect the intended markets’ language needs, and are fully documented in the Technical Documentation.

Design and Manufacturing Information – Annex II (section 3)

This section provides a detailed record of how the device is designed and manufactured. It should allow an external reviewer to understand the design logic, process control and manufacturing traceability. Key content includes:

• Information to allow review of design stages (design inputs, design outputs, traceability).

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

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

Note: The documentation must be up‑to‑date and reflect the current manufacturing process; changes (e.g., new supplier, changed manufacturing site) must be included to remain compliant.

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

Under the MDR, the General Safety and Performance Requirements are set out in Annex I, and manufacturers must show how each applicable requirement is met (or why some are not). In the Technical Documentation you should include:

• A list of all GSPRs (from Annex I) applicable to the device, and justification for any that are not applicable.

• The method(s) used to demonstrate conformity with each applicable GSPR (testing, risk management, clinical evaluation, etc.).

• Specification of harmonised standards, common specifications (CS) or other solutions applied, including precise identification of controlled documents.

• Cross‑references to where the evidence is located within the Technical Documentation (or summary technical documentation).

Importance: Demonstrating GSPR conformity is the heart of the dossier: failure to clearly show how you meet each requirement is a major cause of delays or non‑acceptance.

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

Manufacturers must show they have conducted a systematic approach to risk, assess benefits versus residual risks, and implement risk control measures. This section should contain:

• The documented benefit‑risk analysis referred to in Sections 1 and 8 of Annex I.

• The risk management process and results, including how risks have been identified, evaluated, mitigated and residual risks justified, in line with Section 3 of Annex I

Tip: Link the risk management file with the GSPR section and the clinical/verification validation evidence so the traceability is apparent.

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

This section contains the evidence that the device meets its specifications, safety and performance requirements — including pre‑clinical testing, usability/ergonomics, software validation (if applicable), sterilisation, shelf life, clinical evaluation and investigations where required. Sub‑sections typically include:

1. Pre‑clinical/verification testing

• Laboratory, bench, simulation or animal studies as appropriate.

• Testing of materials, electrical/electronic safety, EMC, software lifecycle, usability, sterilisation/biocompatibility, shelf life.

2. Clinical Evaluation and any Clinical Investigation

• Documentation of the clinical evaluation plan (CEP) and report (CER) aligned with Article 61 and Annex XIV as applicable.

• Where relevant, clinical investigation plans and reports (per Annex XV and MDR Chapter VI).

• Additional information required in specific cases (e.g., devices for lay use, novel devices, implantables).

Note: This section must show traceability from specification → design input/output → verification/validation → risk management → clinical evaluation. Any gaps or lack of traceability are often flagged by Notified Bodies.

Other Considerations (Lifecycle And Maintenance)

Although not always separately numbered in Annex II, your dossier should have a lifecycle view — it must be a “living document” that is maintained and updated, reflecting changes, post‑market data, corrective actions, and device modifications.
Also: For devices already on the market under older directives, the manufacturer should show how legacy devices link to current documentation and how transitions to MDR are managed.

Overview Of Annex III – Technical Documentation On Post‑Market Surveillance

Once the device is on the market, the manufacturer’s obligation does not end. Annex III of the MDR requires the manufacturer to prepare and maintain documentation on post‑market surveillance (PMS) that demonstrates ongoing device safety and performance. The documentation must be presented in a clear, organised, searchable manner. Below are key parts you should structure.

Post‑Market Surveillance Plan – Annex III (section 1)

The PMS Plan outlines how you will proactively and systematically collect, analyse, assess and act on post‑market data. It must address:

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

• Process: how you will collect the above information; methods and tools to assess the data; indicators/thresholds for benefit‑risk reassessment and risk‑management review; methods to investigate complaints, trend analysis protocols; tools to trace devices for corrective actions; communication protocols with authorities, Notified Bodies, users.

• Integration: reference to your procedures to fulfil your obligations under Articles 83, 84 and 86 (vigilance, corrective actions, safety measures). 

• A plan for a Post‑Market Clinical Follow‑Up (PMCF) or justification why PMCF is not applicable (if applicable under Annex XIV Part B).

Practical tip: Your PMS Plan should be fully aligned with your design/product file (Annex II) so that field feedback, incident data and trend outcomes feed into your risk management, clinical evaluation updates and product changes.

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

The Annex requires that for certain device classes (IIa, IIb, III) you prepare and maintain periodic safety update reports (PSURs) summarising your PMS findings and actions taken. For all devices, you must have a PMS Report summarising the results of the PMS system and the conclusions drawn. 

Linkage with Other Processes

The PMS documentation must link into your risk‑management file, clinical evaluation (including PMCF if applicable), vigilance/reporting systems, design change control and regulatory update procedures. This ensures that post‑market experience is fed back into the entire product lifecycle.

Best‑Practices For Structuring The Dossier

Here are some best‑practice tips to help regulatory professionals and device manufacturers prepare a compliant dossier:

• Use a clear table of contents and numbering scheme that mirrors the Annex II and Annex III sections.

• Ensure cross‑references between sections (e.g., risk‑management section referencing the GSPR section, verification/validation referencing design/manufacturing).

• Make sure documents are current, version‑controlled and dated, and that any changes in the product, process or market are reflected.

• Provide rationales when something is not applicable (e.g., a certain GSPR, a clinical investigation) rather than simply marking “N/A”.

• Ensure translations of labels/IFUs are correct for all Member States where the device is marketed.

• Link post‑market surveillance outputs to risk management, design change control and clinical evaluation updates — the dossier must reflect the full lifecycle.

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

• Work proactively with your Notified Body: agree submission format, language, file structure and ensure the documentation is search‑able and logically organised.

Conclusion

In summary, the Technical Documentation under the MDR (Annex II) and the Post‑Market Surveillance documentation (Annex III) form the backbone of your regulatory dossier. They must be robust, well‑structured, up‑to‑date, traceable and clearly demonstrate how you meet the MDR’s requirements for safety, performance, life‑cycle management and post‑market oversight.
By structuring your dossier according to the headings outlined above—and ensuring that each element is fully addressed—you build a strong compliance foundation for CE marking and ongoing conformity.