# Technical Documentation: [Device name and model]

> The technical documentation index and summary for one medical device
> (or device family under one Basic UDI-DI) placed on the EU market,
> structured on Annexes II and III of Regulation (EU) 2017/745 on
> medical devices (MDR). Annex II sets out the six parts of the
> technical documentation; Annex III covers the technical documentation
> on post-market surveillance. The file is the map a notified body or
> competent authority uses to find evidence: it summarises each part
> and points to the controlled records that hold the detail. Replace
> every `[bracketed]` value and every row marked *Example*. This is a
> documentation format, not regulatory or legal advice: the MDR is
> amended from time to time and a targeted revision is in the EU
> legislative process, so check the current consolidated text on
> EUR-Lex, the current MDCG guidance and a qualified regulatory
> professional.

<!--
Guidance: How to use this template
- One file per Basic UDI-DI (or per device family your notified body
  agreed to). Section numbers 1 to 6 follow Annex II; section 7 follows
  Annex III. Keeping that numbering makes the review faster and shows
  nothing is missing.
- Do not paste whole reports in here. Summarise the conclusion in two
  or three sentences and give the document ID and version, so the file
  stays readable and every record stays under its own control.
- Fill sections 0 and 1 first (classification and description): every
  later section depends on the intended purpose and the class.
- The examples continue the fictional "Corvane IP-200 infusion pump"
  from the fictional maker Corvane Medical Ltd used in the risk file,
  software lifecycle and usability templates. Delete them.
- Related templates: risk management file
  (`compliance/iso-14971-risk-file`), design and development file
  (`compliance/iso-13485-design-controls`), software lifecycle file
  (`compliance/medical-device-software-lifecycle`), usability
  engineering file (`compliance/usability-engineering-file`), corrective
  and preventive action (`compliance/capa-nonconformity`), controlled
  document (`compliance/controlled-document`).
-->

## Document control

<!-- Guidance: The technical documentation must be kept up to date (MDR Article 10) and retained for the period set in that article after the last device is placed on the market. Record every revision, because the notified body will compare versions between audits. -->

| Field | Value |
|---|---|
| Document ID | [TD-NNN] |
| Device and Basic UDI-DI | [Name, model, Basic UDI-DI] |
| Manufacturer and SRN | [Legal name, address, single registration number] |
| Authorised representative (if outside the EU) | [Name, address, SRN] |
| Person responsible for regulatory compliance | [@name] |
| Risk class and rule | [For example class IIb, Annex VIII rule 12] |
| Notified body | [Name and four-digit number] |
| Version | [0.1] |
| Status | [Draft / In review / Approved] |
| Owner | [@regulatory-lead] |
| Last updated | YYYY-MM-DD |
| Classification | [Confidential] |

### Approvals

| Role | Name | Decision | Date |
|---|---|---|---|
| Regulatory affairs lead | [@name] | [Approved] | YYYY-MM-DD |
| Person responsible for regulatory compliance | [@name] | [Approved] | YYYY-MM-DD |
| Quality assurance | [@name] | [Approved] | YYYY-MM-DD |

### Revision history

| Version | Date | Author | Change summary |
|---|---|---|---|
| 0.1 | YYYY-MM-DD | [@name] | Structure and device description |
| 0.8 | YYYY-MM-DD | [@name] | *Example:* Verification, clinical evaluation and PMS sections completed for notified body submission |
| 1.0 | YYYY-MM-DD | [@name] | *Example:* Updated after notified body technical documentation assessment |

## Contents

0. Regulatory strategy and classification
1. Device description and specification (Annex II, section 1)
2. Information to be supplied by the manufacturer (Annex II, section 2)
3. Design and manufacturing information (Annex II, section 3)
4. General safety and performance requirements (Annex II, section 4)
5. Benefit-risk analysis and risk management (Annex II, section 5)
6. Product verification and validation (Annex II, section 6)
7. Post-market surveillance documentation (Annex III)
8. Declaration of conformity and registrations
9. Other markets: mapping table
10. Glossary and references

## 0. Regulatory strategy and classification

<!-- Guidance: Record the qualification as a device, the class with the rule applied and the reasoning, and the conformity assessment route agreed with the notified body. A classification without the rule text reasoning is the most common early finding. Check the classification rules in Annex VIII and the current MDCG guidance, especially for software. -->

| Item | Value |
|---|---|
| Qualification as a medical device | *Example:* Intended for the administration of medicines by infusion, a medical purpose under Article 2(1) |
| Classification rule(s) considered | *Example:* Rule 12 (active device administering medicines); rule 11 considered for the software and not applied separately because the software drives the device |
| Resulting class | *Example:* IIb, because administration can be potentially hazardous given the medicines and the mode of delivery |
| Conformity assessment route | *Example:* Article 52(4) for class IIb: Annex IX chapters I (quality management system) and III (administrative provisions), with assessment of the technical documentation under Annex IX section 4 for at least one representative device per generic device group; confirm the sampling with the notified body. As a class IIb active device administering medicinal products (rule 12), the device falls under the clinical evaluation consultation procedure of Article 54(1)(b) unless an Article 54(2) exemption applies |
| Harmonised standards and common specifications applied | See section 4 |
| Transition status | [New device under the MDR / legacy device under the Article 120 transitional provisions as amended; check the current dates] |

## 1. Device description and specification (Annex II, section 1)

<!-- Guidance: Describe the device so that a reviewer who has never seen it understands what it is, what it does, who uses it on whom, and why it is classified as it is. Point 1.1 lists the elements; point 1.2 covers previous and similar generations. -->

### 1.1 Description and specification

| Element | Content | Record |
|---|---|---|
| Name and general description, intended purpose, intended users | *Example:* Corvane IP-200 volumetric infusion pump for continuous and intermittent intravenous infusion, used by trained nurses in hospitals | IFU [ID], use specification UEF-003 section 1 |
| Basic UDI-DI or other identifier | [Basic UDI-DI] | UDI assignment record |
| Patient population, conditions, indications, contraindications, warnings | *Example:* Adults and children above 10 kg; not for enteral feeding | Clinical evaluation plan CEP-004 |
| Principles of operation and mode of action | *Example:* Peristaltic pumping mechanism, software rate control, independent safety monitor | Design description DD-010 |
| Rationale for qualification as a device | See section 0 | |
| Risk class and classification rule | See section 0 | |
| Novel features | *Example:* Drug library with signed files and hard limits; none clinically novel | Design description DD-010 |
| Accessories, other devices and products used in combination | *Example:* Dedicated administration sets (separate technical documentation TD-015), mains adaptor | Accessory list ACC-01 |
| Configurations and variants | *Example:* IP-200 (single channel), IP-200D (dual channel) | Variant matrix VAR-01 |
| Key functional elements, with diagrams | *Example:* Pumping mechanism, main controller, safety monitor, display, battery | System architecture SA-02 |
| Materials in contact with the body | *Example:* None directly; fluid path materials covered in TD-015 | Material list MAT-01 |
| Technical specifications | *Example:* Rate range 0.1 to 1,200 mL/h, accuracy ±5% of set rate | Product specification PS-01 |

### 1.2 Previous and similar generations

| Device | Relationship | Relevance | Record |
|---|---|---|---|
| Corvane IP-100 *(Example)* | Previous generation by the same manufacturer | Field data used in risk and clinical evaluation | PMS report PMS-IP100-YYYY |
| [Similar devices on the market] | Comparable devices by other manufacturers | State of the art, similar device data | Clinical evaluation report CER-004 section [n] |

## 2. Information to be supplied by the manufacturer (Annex II, section 2)

<!-- Guidance: List every label and instructions for use version, the languages for each market, and where the information required by Annex I chapter III is placed. Reviewers check that warnings from the risk file actually appear in the labelling. -->

| Item | ID and version | Languages | Annex I chapter III check |
|---|---|---|---|
| Device label *(Example)* | LBL-200 v3 | Symbols plus [languages] | Checklist LC-01 |
| Packaging label *(Example)* | LBL-201 v2 | [Languages] | Checklist LC-01 |
| Instructions for use *(Example)* | IFU-200 v4 | [Languages accepted in each Member State of sale] | Checklist LC-02 |
| Electronic instructions for use (if used) | [ID, or not used] | | [Check the implementing rules on electronic instructions for use] |
| Quick reference card *(Example)* | QRC-200 v2 | [Languages] | Usability file UIS-05 |

## 3. Design and manufacturing information (Annex II, section 3)

<!-- Guidance: Give enough to understand the design stages and the manufacturing processes and their validation, and identify every site where design and manufacturing happen, including critical suppliers and subcontractors. -->

### 3.1 Design stages

| Stage | Output | Record |
|---|---|---|
| Design inputs *(Example)* | User needs and design inputs | Design and development file DDF-008 |
| Software lifecycle *(Example)* | Software development plan, verification, release | SDP-011 |
| Usability engineering *(Example)* | Use specification, formative and summative evaluation | UEF-003 |
| Design transfer *(Example)* | Device master record | DMR-200 |

### 3.2 Manufacturing processes and validation

| Process | Validation | Monitoring | Final test |
|---|---|---|---|
| PCB assembly *(Example)* | Process validation PV-11 | In-line optical inspection | Board functional test |
| Final assembly and flow calibration *(Example)* | Process validation PV-14 | Statistical process control on flow accuracy | Final acceptance test FAT-200 |
| Software installation *(Example)* | Validated programming station PV-17 | Checksum verification | Version check at final test |

### 3.3 Sites, suppliers and subcontractors

| Site or supplier | Activity | Critical? | Control | Certificate |
|---|---|---|---|---|
| Corvane Medical Ltd, [site] *(Example)* | Design, final assembly, release | Yes | Own QMS | ISO 13485 certificate [ID] |
| [Supplier] *(Example)* | PCB assembly | Yes | Supplier audit, quality agreement | [Certificate ID] |
| [Supplier] | [Activity] | [Yes / No] | [Control] | [Certificate] |

## 4. General safety and performance requirements (Annex II, section 4)

<!-- Guidance: Show, for each requirement of Annex I, whether it applies, how conformity is shown (harmonised standard, common specification or other solution) and which controlled document holds the evidence. A requirement marked not applicable needs a reason. The table below is a working extract, not a copy of Annex I: list every section that applies to your device. -->

| Annex I section | Topic (paraphrase) | Applies? | Method of conformity | Evidence |
|---|---|---|---|---|
| 1 to 9 *(Example)* | General requirements: performance, risk management, risk reduction, use error, lifetime, transport and storage | Yes | EN ISO 14971:2019/A11:2021, EN 62366-1 [version applied] | RMF-012, UEF-003 |
| 10 *(Example)* | Chemical, physical and biological properties | Partly | Fluid path in TD-015; housing materials assessed for user contact | MAT-01 |
| 14 *(Example)* | Construction and interaction with the environment | Yes | EN 60601-1 series, electromagnetic compatibility testing | Test reports TR-301, TR-302 |
| 17 *(Example)* | Electronic programmable systems and software, including IT security | Yes | EN 62304 [version applied], cybersecurity per IEC 81001-5-1 | SDP-011, security file SEC-02 |
| 18 *(Example)* | Active devices and devices connected to them, including alarms | Yes | Collateral standard on alarm systems, infusion pump particular standard | TR-303, TR-304 |
| 21 *(Example)* | Devices supplying energy or substances to the patient | Yes | Flow accuracy and over-delivery protection testing | TR-305, ST-210 |
| 22 *(Example)* | Devices for use by lay persons | No | Professional use only, stated in intended purpose | IFU-200 section 1 |
| 23 *(Example)* | Label and instructions for use | Yes | EN ISO 15223-1 symbols, labelling checklist | LC-01, LC-02 |

Harmonised standards: check the references published in the Official
Journal under the MDR (Commission Implementing Decision (EU) 2021/1182
and its amendments) and record the exact version applied.

## 5. Benefit-risk analysis and risk management (Annex II, section 5)

<!-- Guidance: Summarise the benefit-risk conclusion and point to the risk management file. The notified body will sample hazards and follow them to controls and verification, so make sure the IDs match across files. -->

| Item | Summary | Record |
|---|---|---|
| Risk management plan and file | *Example:* ISO 14971:2019 process, file RMF-012 | RMF-012 |
| Main hazards and controls | *Example:* Over-dose (HZ-02, HZ-04): independent safety monitor and drug library hard limits; free flow (HZ-07): anti-free-flow clip | RMF-012 sections 3 to 5 |
| Overall residual risk | *Example:* Acceptable when weighed against the clinical benefit of controlled infusion | RMF-012 section 8 |
| Benefit-risk conclusion | *Example:* Benefits outweigh residual risks for the intended purpose | CER-004 conclusion |

## 6. Product verification and validation (Annex II, section 6)

<!-- Guidance: List the results and critical analysis of every verification and validation, and the clinical evidence. Point 6.1 covers pre-clinical and clinical data; point 6.2 covers additional information needed only in specific cases. Mark the specific cases that do not apply with a reason. -->

### 6.1 Pre-clinical and clinical data

| Area | Tests or studies | Result summary | Record |
|---|---|---|---|
| Electrical safety and EMC *(Example)* | EN 60601-1 series testing | Passed, no deviations | TR-301, TR-302 |
| Performance *(Example)* | Flow accuracy over the rate range | Within ±5% across the range | TR-305 |
| Software verification and validation *(Example)* | System testing, traceability to requirements | All requirements verified; known anomalies evaluated | SDP-011 sections 7 and 8 |
| Usability *(Example)* | Summative evaluation USAB-07 and USAB-07b | No remaining use error on selected scenarios | UEF-003 section 9 |
| Biocompatibility | [Applies / not applicable with reason] | | [Record] |
| Stability and shelf life *(Example)* | Battery ageing, packaged transport tests | Meets specification for the stated lifetime | TR-306 |
| Clinical evaluation *(Example)* | Clinical evaluation plan and report (Article 61, Annex XIV Part A) | Sufficient clinical evidence for the intended purpose | CEP-004, CER-004 |
| Post-market clinical follow-up *(Example)* | PMCF plan and evaluation report (Annex XIV Part B), or justification if not applicable | PMCF survey of user sites planned | PMCF-P-004 |

### 6.2 Additional information in specific cases

| Specific case | Applies? | Reason or record |
|---|---|---|
| Device incorporating a medicinal substance | *Example:* No | No medicinal substance in the device |
| Tissues or cells of human or animal origin, or derivatives | *Example:* No | None used |
| Substances absorbed by or dispersed in the body | *Example:* No | Not applicable to an infusion pump |
| Substances of concern (CMR or endocrine-disrupting) | *Example:* Not in the pump; fluid path covered in TD-015 | MAT-01 |
| Sterile or defined microbiological condition | *Example:* No for the pump; yes for administration sets (TD-015) | TD-015 |
| Measuring function | [Applies / no, with reason] | [Record] |
| Connection to other devices | *Example:* Yes, optional network connection to hospital systems | Interoperability verification TR-310 |

## 7. Post-market surveillance documentation (Annex III)

<!-- Guidance: Annex III expects the post-market surveillance plan (Article 84) and, by class, the periodic safety update report (Article 86) or the post-market surveillance report (Article 85). The plan must be proactive and systematic, with indicators and thresholds that trigger a re-assessment of benefit-risk. -->

### 7.1 Post-market surveillance plan

| Element | Content *(Example)* |
|---|---|
| Information collected | Serious incidents and field safety corrective actions, non-serious incidents and undesirable side effects, trend data, literature and databases, complaints and feedback from users, distributors and importers, public information on similar devices |
| Methods and analysis | Monthly complaint trending, yearly literature search, statistical trend method [method] |
| Indicators and thresholds | Occlusion alarm complaints above 2 per 1,000 devices per year trigger risk file review; any over-infusion complaint triggers investigation |
| Trend reporting | Method to detect a significant increase in incidents, per Article 88 |
| Communication | Competent authorities, notified body, economic operators, users |
| Links | CAPA procedure, traceability through UDI, PMCF plan PMCF-P-004 |

### 7.2 Periodic safety update report or PMS report

| Item | Value |
|---|---|
| Report type | *Example:* PSUR (Article 86), as required for class IIb |
| Update frequency | *Example:* At least yearly for class IIb; check the article and current MDCG guidance |
| Latest report | [PSUR-ID, version, date] |
| Submission | *Example:* Made available to the notified body; check the current EUDAMED requirements |

```mermaid
flowchart LR
  SRC["Field data sources"] --> PMS["PMS plan (Annex III 1.1)"]
  PMS --> ANA["Trend and signal analysis"]
  ANA -->|"Threshold crossed"| RMF["Risk management file"]
  ANA --> PSUR["PSUR or PMS report (Annex III 1.2)"]
  RMF --> CER["Clinical evaluation update"]
  CER --> PSUR
  RMF --> CAPA["Corrective and preventive action"]
```

## 8. Declaration of conformity and registrations

<!-- Guidance: Record the EU declaration of conformity (Article 19, Annex IV), the CE marking, the UDI assignment and the registrations in EUDAMED that apply to your device. These are outside Annexes II and III but reviewers expect to find them linked from the file. -->

| Item | Value | Record |
|---|---|---|
| EU declaration of conformity | [ID, version, date] | DoC-200 |
| Notified body certificate | [Certificate number, expiry date] | [Record] |
| UDI-DI and Basic UDI-DI registration | [Status] | [EUDAMED reference] |
| Summary of safety and clinical performance (Article 32) | [Required / not required for this class] | [Record] |
| Retention of technical documentation | [Period set by Article 10 for this device] | Archive procedure |

## 9. Other markets: mapping table

<!-- Guidance: Many manufacturers reuse the same evidence for several markets. Map it here, but do not assume the structure or terms carry over: each market has its own rules, dates and submission formats. The entries below are dated examples only. -->

| Market | Framework (as checked October 2026) | Main dossier | Reuse from this file |
|---|---|---|---|
| European Union | Regulation (EU) 2017/745 | This technical documentation | All |
| Great Britain | Medical Devices Regulations 2002 (as amended), with post-market surveillance requirements in force from 16 June 2025 | UKCA technical documentation, or CE marking where recognised; check the current MHRA guidance on recognition dates | Sections 1 to 7, with UK-specific labelling and registration |
| United States | Federal Food, Drug, and Cosmetic Act; premarket notification (21 CFR Part 807) or premarket approval; QMSR (21 CFR Part 820, effective 2 February 2026) | 510(k), De Novo or PMA submission | Verification, software, human factors and risk evidence, rearranged to FDA formats |

## 10. Glossary and references

<!-- Guidance: Keep the definitions short and point to Article 2 of the MDR for the legal definitions. List the guidance documents and their revision numbers, as MDCG documents are revised often. -->

| Term | Working meaning in this file |
|---|---|
| Basic UDI-DI | The main identifier of a device model in the EU database, linking it to its technical documentation and certificates |
| General safety and performance requirements | The requirements in Annex I that every device must meet |
| PMCF | Post-market clinical follow-up: the continuing collection of clinical data after the device is on the market |
| PSUR | Periodic safety update report: the summary of post-market surveillance results for class IIa, IIb and III devices |
| SRN | Single registration number of an economic operator in the EU database |

| Reference | Edition or date | Use |
|---|---|---|
| Regulation (EU) 2017/745 on medical devices | Adopted 5 April 2017, amended (including by Regulation (EU) 2023/607 on transitional provisions); check the consolidated text | Annexes II and III structure, articles cited: https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng |
| Commission proposal for a targeted revision of the MDR and IVDR | Published 16 December 2025, in the legislative process as of October 2026 | Watch for changes to documentation and transition rules |
| MDCG guidance documents | Check the current list and revision | For example MDCG 2019-11 (software qualification and classification) and MDCG 2022-21 (PSUR): https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en |
| ISO 13485, ISO 14971, IEC 62304, IEC 62366-1 | Editions applied, see section 4 | Supporting processes |

## Standard and licence note

Based on Regulation (EU) 2017/745 (the MDR), Annex II (technical
documentation) and Annex III (technical documentation on post-market
surveillance), public EU law available free on EUR-Lex. The section
numbering follows the Annexes; all wording is an original paraphrase and
no Annex text is reproduced. The MDR has been amended several times and
a targeted revision proposed by the Commission on 16 December 2025 was
still in the legislative process when this template was checked in
October 2026, so check the current consolidated text and the MDCG
guidance before use. Paid standards named here (ISO 13485, ISO 14971,
IEC 62304, IEC 62366-1, IEC 60601 series) are cited by name and number
only; their official texts are available for purchase or licensed
access from ISO (https://www.iso.org), IEC (https://webstore.iec.ch) and
national standards bodies. The device, documents, IDs and thresholds are
fictional examples. This template is not regulatory or legal advice:
check the current official texts and a qualified regulatory
professional.

Official text: Publications Office of the European Union, free access:
https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng

Template licence: MIT.