A Class I device still needs a complete technical file. Article 10(4) of Regulation (EU) 2017/745 requires manufacturers to draw up and keep up to date technical documentation in accordance with Annexes II and III, regardless of class. The minimum viable Class I technical file is the one that addresses every section of Annex II and Annex III at a depth proportionate to Class I risk, and nothing more. No Notified Body reviews this file for standard Class I devices under Article 52(7), but the competent authority can request it at any time, and the EU declaration of conformity under Annex IV references it as the evidence base. Minimum viable means every section present, every section defensible, no padding, no missing pieces.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • Article 10(4) of Regulation (EU) 2017/745 requires every manufacturer, including Class I manufacturers, to draw up and keep up to date technical documentation in accordance with Annexes II and III.
  • The minimum viable Class I technical file addresses every section of Annex II (device description, information supplied, design and manufacturing, GSPR, benefit-risk and risk management, verification and validation) and Annex III (post-market surveillance), at Class I depth.
  • Proportionate does not mean partial. A Class I file that skips the GSPR checklist or the benefit-risk analysis is not a light file; it is an incomplete file.
  • The clinical evaluation for most Class I devices can be literature-based and equivalence-based under Annex XIV, but it has to exist in writing and feed the Annex II benefit-risk section.
  • The technical file is referenced by the EU declaration of conformity under Annex IV and must be available to competent authorities for at least ten years after the last device has been placed on the market under Article 10(8).

Why "minimum viable" is the right frame for a Class I file

Class I is the only conformity assessment route under Regulation (EU) 2017/745 where the manufacturer self-declares conformity for a standard device without a Notified Body certificate for the device itself. Article 52(7) is the legal basis. That legal freedom gets misread as permission to write less than the Regulation actually requires. It is not.

The minimum viable framing keeps both halves honest. The file has to cover every section of Annex II and Annex III — that is the minimum — and it has to be usable the day a competent authority walks in and asks to see it — that is the viable part. Anything beyond those two requirements is either bloat carried over from a Class IIa or Class III template or consultancy deliverables scoped to a different class. Cut it.

A Class I founder who treats the file as an optional summary ends up with a stack of templates that does not survive first contact with a competent authority. A Class I founder who treats the file as if it were a Class III file ends up paying six figures for paper that nobody will ever read. The minimum viable file sits between those two failure modes. It is short, it is complete, and it is defensible.

For the conceptual overview of what technical documentation is and why it exists, see Technical Documentation Under MDR: What It Is and Why Startups Get It Wrong. For the classification context, see Class I Medical Devices Under MDR. For the process checklist around the file, see The Conformity Assessment Procedure for Class I Devices.

What Class I technical documentation actually requires

Article 10(4) of Regulation (EU) 2017/745 states the obligation directly: manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices, and the technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The documentation and the post-market surveillance documentation shall include the elements set out in Annexes II and III.

Read that together with Article 52(7): for a Class I standard device, the manufacturer draws up the technical documentation set out in Annexes II and III and issues the EU declaration of conformity referred to in Article 19 in the format of Annex IV. No Notified Body certificate for the device itself. No reduced scope for Annex II. The full content list of Annex II applies. The difference from Class III is the depth, not the sections.

MDCG 2021-24 reinforces this: classification determines the conformity assessment route and the depth of documentation, but not which sections of Annex II apply. Every section applies to every class. For a Class I non-sterile bandage, the GSPR checklist is shorter than for a Class III implant, but the checklist still exists, still traces every applicable requirement to evidence, and still sits inside the technical file.

The minimum viable structure

The minimum viable Class I file follows the Annex II structure directly. No creative reorganisation. No compression of required sections into a single chapter. Matching the Annex II numbering makes the file easier for a competent authority to read and easier for the manufacturer to maintain.

Section 1 — Device description and specification, including variants and accessories. A written description of the device, its intended purpose, its intended users, the patient population, the principles of operation, the materials, the variants, any accessories, and the UDI-DI. For a simple Class I device this can run to three or four pages. For a Class I device with multiple variants it runs longer. The content is required; the length is whatever it takes to describe the device honestly.

Section 2 — Information supplied by the manufacturer. The label, the instructions for use, the packaging text, and any promotional materials, in every language the device ships in. These live in the technical file because they are part of what the manufacturer is declaring conformity for. Inconsistencies between the IFU and the intended purpose are a common finding.

Section 3 — Design and manufacturing information. How the device was designed, what the design inputs and outputs were, where and how it is manufactured, who the critical suppliers are, and how manufacturing is controlled. For a Class I contract-manufactured device, this section documents the manufacturing partner arrangement.

Section 4 — General safety and performance requirements. The GSPR checklist. Annex I of Regulation (EU) 2017/745 lists the general safety and performance requirements, and the manufacturer must demonstrate, requirement by requirement, that each applicable GSPR is met — or document why it does not apply. The checklist references the evidence (test report, standard applied, risk analysis, clinical evaluation) for each GSPR. Skipping this section is not proportionate; it is non-compliant.

Section 5 — Benefit-risk analysis and risk management. The risk management file under EN ISO 14971:2019+A11:2021 and the benefit-risk statement. For a Class I device, the risk management file can be compact — hazard list, risk estimation, risk control, residual risk, overall residual risk — but it must exist and must be connected to the GSPR checklist.

Section 6 — Product verification and validation. Test reports, verification records, validation activities, and the clinical evaluation report. For most Class I devices, the clinical evaluation is literature-based and equivalence-based under Annex XIV rather than a new clinical investigation. Verification and validation scale with the device: a manual bandage needs less than a reusable surgical instrument, but both need documented evidence that the device does what the intended purpose claims.

Annex III — Post-market surveillance technical documentation. The PMS plan, the process for collecting post-market data, and the plan for updating the documentation based on PMS findings. MDCG 2025-10 (December 2025) describes the PMS system in practice. For Class I, a PMS report replaces the PSUR — PSURs are required from Class IIa upward.

GSPR checklist for a Class I device

The GSPR checklist is the section founders are most tempted to skip and the section competent authorities reach for first. The checklist is not a formality. It is the bridge between Annex I of the Regulation and the evidence sitting in the rest of the file.

The minimum viable GSPR checklist for a Class I device has five columns: the GSPR number (from Annex I), the GSPR text (or a summary), the applicability (applicable or not applicable with justification), the method of compliance (harmonised standard applied, internal test, risk control, labelling, literature), and the reference to the evidence inside the technical file. For a Class I non-sterile device, many GSPRs in Annex I Chapter II — chemical and physical properties, infection control, devices incorporating substances, construction of devices and environmental interactions — will be marked not applicable with a short written justification. That is legitimate. The requirement is to address every GSPR, not to apply every GSPR.

The checklist does not need to be long. It needs to be complete. A Class I GSPR checklist that runs to ten or fifteen pages with honest applicability justifications and traceable evidence references is minimum viable. A Class I GSPR checklist that runs to two paragraphs of "compliant" without references is not.

Clinical evaluation depth for Class I

Article 61 of Regulation (EU) 2017/745 requires a clinical evaluation for every medical device, and Annex XIV sets out the methodology. For most Class I devices the clinical evaluation is based on literature review and clinical data from equivalent devices rather than a new clinical investigation. The clinical evaluation report sits inside the Annex II Section 6 verification and validation section of the technical file and feeds the benefit-risk statement in Section 5.

The minimum viable Class I clinical evaluation has a plan (clinical evaluation plan), a literature search with a documented search strategy and inclusion criteria, an appraisal of the data found, an analysis of whether the data is sufficient to demonstrate conformity with the relevant GSPRs, and a conclusion. For a low-risk Class I device with a clear literature base, the resulting CER can be a short document, but short is not the same as absent. Skipping the clinical evaluation because the device is Class I is the single most common audit finding on Class I files.

Labelling inside the technical file

Annex II Section 2 places the label, the instructions for use, and the packaging text inside the technical file. This is not an afterthought. Labelling is part of the intended purpose the manufacturer is declaring conformity for, and a label that says something different from the Section 1 device description or the Section 6 clinical evaluation undermines the whole file.

The minimum viable labelling section contains the final artwork for the label and the IFU, in every language the device ships in, with the version numbers matching what is actually in the field. For a device with multiple variants, each variant has its own label. For electronic IFU (eIFU), the conditions of Commission Implementing Regulation (EU) 2021/2226 apply, and for most Class I devices supplied to lay users paper IFU will still be required. For deeper coverage of the labelling requirements, see MDR Labelling Requirements: The Annex I Chapter III Checklist and Instructions for Use Under MDR: What Annex I Requires.

The post-market surveillance section under Annex III

Annex III of Regulation (EU) 2017/745 sets out the technical documentation on post-market surveillance. For Class I, the PMS section is typically the shortest section of the file, but it is required. Article 83 of the Regulation requires every manufacturer to plan, establish, document, implement, maintain, and update a PMS system proportionate to the risk class.

The minimum viable Class I PMS section contains the PMS plan (what data is collected, from which sources, at what frequency, and how it is analysed), the process for handling complaints and incidents, the process for feeding PMS findings back into risk management and the clinical evaluation, and the format of the PMS report. MDCG 2025-10 (December 2025) describes the PMS system in practice and is the authoritative guidance. For Class I, a PMS report replaces the PSUR that applies from Class IIa upward. The PMS section is not optional for Class I; it is the obligation that keeps the file alive after market entry.

Declaration of conformity under Annex IV

The EU declaration of conformity is the legal instrument that closes the Class I conformity assessment loop. Annex IV of Regulation (EU) 2017/745 sets out the minimum content: manufacturer name and address, authorised representative where applicable, the name and product reference of the device, the UDI-DI where applicable, the risk class, a statement that the device complies with the Regulation, references to any harmonised standards and common specifications applied, and the date, place, and signature of the person authorised to sign on behalf of the manufacturer. For a Class I standard device, there is no Notified Body number next to the CE mark because no Notified Body certificate is issued for the device itself.

The declaration references the technical file as its evidence base. Signing the declaration is signing for everything in the file. That is why the minimum viable Class I file matters more than the volume of pages: the declaration is only as credible as the weakest section of the file behind it.

Common mistakes on Class I technical files

Using a Class III template for a Class I device. The file ends up ten times larger than it needs to be, most sections are not actually tailored to the device, and the team cannot maintain it. Subtract the sections that do not apply.

Skipping the GSPR checklist. The most frequent audit finding. "Proportionate" does not mean "omitted."

Treating the clinical evaluation as optional. Article 61 applies to all classes. A paragraph is not a clinical evaluation; a literature-based CER with a plan, a search, an appraisal, an analysis, and a conclusion is.

Drafting the declaration of conformity before the file is complete. The declaration references evidence that does not yet exist and commits the signatory to claims that cannot yet be supported.

Inconsistent intended purpose across the file, the label, the IFU, and the website. The intended purpose in Section 1 must match every other place it appears. This is where a competent authority starts.

Treating Annex III as a footnote. The PMS section keeps the file alive. A file without a PMS plan is a snapshot, not a technical file.

The Subtract to Ship angle

The Subtract to Ship methodology treats the Class I minimum viable technical file as the cleanest application of the Operations Pass in the framework. Every required section is present because the Regulation requires it. Every section beyond the Regulation is cut because nothing in Class I requires it. The file traces section by section to Annex II and Annex III of Regulation (EU) 2017/745 and stops there.

The subtraction is not about doing less work than the Regulation requires. It is about refusing to do work the Regulation does not require. A Class III technical file template applied to a Class I device doubles the workload without improving compliance. Annex II has seven sections for Class I, the same seven sections as for Class III, but at Class I depth. That is the whole scope. For the methodology, see The Subtract to Ship Framework for MDR Compliance.

Reality Check — Is your Class I technical file minimum viable?

  1. Does your file address every section of Annex II, in the Annex II order, with a written section for each?
  2. Is your GSPR checklist complete, with applicability decisions justified in writing and evidence references that point to real documents inside the file?
  3. Does your clinical evaluation report exist in writing, referencing Article 61 and Annex XIV, with a plan, a literature search, an appraisal, and a conclusion?
  4. Are your label, IFU, and promotional materials inside Section 2 of the file, with version numbers matching what is in the field?
  5. Is your risk management file compliant with EN ISO 14971:2019+A11:2021 and connected to the GSPR checklist in Section 4?
  6. Does your Annex III PMS section contain a PMS plan, a complaints process, and a PMS report format?
  7. Is your EU declaration of conformity drafted per Annex IV, referencing the file as its evidence base, and ready to sign?
  8. Could you hand the full file to a competent authority next week and defend every section within a reasonable review?

Frequently Asked Questions

Does a Class I device really need a technical file? Yes. Article 10(4) of Regulation (EU) 2017/745 requires every manufacturer, regardless of class, to draw up and keep up to date technical documentation in accordance with Annexes II and III. The Class I file can be proportionate to the risk, but every section of Annex II and Annex III must be addressed.

How long does a minimum viable Class I technical file typically run? There is no word count in the Regulation. In practice, a minimum viable file for a simple Class I device runs between 80 and 200 pages across all sections, including labelling, the GSPR checklist, the risk management file, the clinical evaluation report, and the PMS plan. For a Class I device with multiple variants or complex intended use, it runs longer.

Can a Class I technical file skip the GSPR checklist? No. Annex II Section 4 requires the demonstration of conformity with the general safety and performance requirements in Annex I. For GSPRs that do not apply, the checklist documents the non-applicability with written justification. Skipping the checklist entirely is not compliant at any class.

Is a clinical evaluation required for a Class I device's technical file? Yes. Article 61 of Regulation (EU) 2017/745 requires a clinical evaluation for every medical device. For most Class I devices, the evaluation can be based on literature and equivalence under Annex XIV rather than a new clinical investigation, and the resulting CER can be compact, but it must exist and must be referenced in the technical file.

Who reviews the Class I technical file? For standard Class I devices under Article 52(7), no Notified Body reviews the file. The manufacturer is responsible for drawing it up and keeping it current. Competent authorities can request the file at any time under their market surveillance powers, and during an investigation they will read it section by section.

How long must the Class I technical file be retained? Under Article 10(8) of Regulation (EU) 2017/745, the technical documentation must be kept available for competent authorities for at least ten years after the last device covered by the declaration of conformity has been placed on the market. Fifteen years applies to implantable devices but is not relevant for Class I in practice.

Does the file need to be in any specific language? The Regulation does not mandate a specific language for the internal technical file, but the label and IFU have language requirements set by each Member State where the device is placed on the market. Most manufacturers maintain the core technical file in English and provide national-language labelling and IFU.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10(4) (technical documentation obligation) and Article 10(8) (retention period), Article 52(7) (conformity assessment for Class I), Annex II (technical documentation), Annex III (technical documentation on post-market surveillance), Annex IV (EU declaration of conformity). Official Journal L 117, 5.5.2017.
  2. MDCG 2021-24 — Guidance on classification of medical devices, October 2021.
  3. MDCG 2025-10 — Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, December 2025.
  4. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes.
  5. EN ISO 14971:2019+A11:2021 — Medical devices — Application of risk management to medical devices.

This post is part of the Technical Documentation & Labeling series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The Class I technical file is the section of the MDR where "minimum viable" and "complete" have to mean the same thing. Every section of Annex II and Annex III present, every section at Class I depth, nothing padded and nothing missing — that is the file that survives first contact with a competent authority, and that is the file the EU declaration of conformity under Annex IV is actually signed against.