--- title: The Conformity Assessment Procedure for Class I Devices: A Startup Checklist description: The Class I self-certification path is the lightest under MDR, but still has specific steps. Here is the startup checklist from intended purpose to declaration of conformity. authors: Tibor Zechmeister, Felix Lenhard category: Device Classification & Conformity primary_keyword: conformity assessment Class I checklist canonical_url: https://zechmeister-solutions.com/en/blog/conformity-assessment-class-i-checklist source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # The Conformity Assessment Procedure for Class I Devices: A Startup Checklist *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **The conformity assessment Class I checklist for a standard (non-sterile, non-measuring, non-reusable-surgical-instrument) device under Regulation (EU) 2017/745 has nine ordered steps: fix the intended purpose, confirm the Class I classification under Annex VIII, build a QMS proportionate to the risk class, compile the technical documentation per Annexes II and III, complete the clinical evaluation, finalise labelling and the instructions for use, draw up the EU declaration of conformity under Annex IV and Article 19, register the manufacturer and the device, and affix the CE marking. Article 52(7) is the legal basis. None of the steps is optional, and none requires a Notified Body certificate for the device itself.** **By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.** --- ## TL;DR - The Class I standard conformity assessment procedure is defined by Article 52(7) of Regulation (EU) 2017/745: 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. - The checklist has nine ordered steps. Each step depends on the one before it. Running them out of order is the single most common reason Class I projects stall or produce a file that does not hold together. - None of the steps requires a Notified Body certificate for a standard Class I device. The full Article 10 manufacturer obligations still apply, and the competent authority can request the file at any time. - The EU declaration of conformity under Annex IV is a legal instrument, not a form letter. Signing it commits the manufacturer to the accuracy of every claim in the underlying technical file. - For Class Is, Im, or Ir devices, the same nine-step spine applies, plus a Notified Body certificate for the specific aspect (sterility, metrology, or reprocessing) that triggered the sub-category. --- ## Why a checklist for the lightest path Class I standard is the lightest conformity assessment path in the entire MDR. That fact is also the reason it is the most frequently mishandled. Founders treat "no Notified Body for the device" as "no structure required," and the file that results is a stack of templates with the wrong company name, a declaration of conformity that cites the wrong annex, and a clinical evaluation that amounts to a paragraph of wishful thinking. Competent authorities can request any of this at any time. When they do, the absence of structure shows immediately. The checklist below is the minimum defensible spine. It is ordered because the order matters. Fixing the intended purpose after the technical file is written means rewriting the technical file. Building the QMS before the intended purpose is stable means auditing against a moving target. Drafting the declaration of conformity before the clinical evaluation is complete means signing a document whose underlying claims do not yet exist. Walk the steps in order, do each one at Class I depth, and the file assembles itself without bloat. This post is the process walkthrough. For the conceptual overview of what Class I means and when it applies, see [Class I Medical Devices Under MDR](/blog/class-i-medical-devices-under-mdr). For the broader route decision across all classes, see [Choosing the Right Conformity Assessment Route for Your Startup's Device Class](/blog/choosing-conformity-assessment-route-startup). ## Step 1 — Fix the intended purpose The intended purpose is the foundation of everything else. Article 2(12) of Regulation (EU) 2017/745 defines the intended purpose as the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials or statements, and as specified by the manufacturer in the clinical evaluation. Every subsequent step in the checklist depends on this sentence being written down, stable, and defensible. For Class I specifically, the intended purpose also serves as the gate: if the intended purpose does not map to the Article 2(1) definition of a medical device, MDR does not apply at all. If it does, the intended purpose then drives the Annex VIII classification, the GSPR selection, the clinical evaluation scope, the labelling text, and the declaration of conformity content. Fix it first. Fix it once. If it changes later, every downstream step has to be revisited. **Checklist for Step 1:** intended purpose documented in a single controlled sentence, target patient population defined, intended users defined, clinical indications listed, contraindications listed, and the Article 2(1) qualification confirmed in writing. ## Step 2 — Confirm the Class I classification Classification is not a preference. It is the output of applying Annex VIII of Regulation (EU) 2017/745 to the intended purpose. For non-invasive devices, the default is Annex VIII Rule 1: all non-invasive devices are classified as Class I unless one of the subsequent rules applies. Walking Rules 2, 3, and 4 and confirming that none of them applies is what makes the Class I classification defensible. MDCG 2021-24 is the authoritative interpretation document for the classification rules and should be read alongside Annex VIII directly. The output of Step 2 is a written classification rationale that names the specific Annex VIII rule and explains why it applies. This rationale lives in the technical documentation and is the first thing a competent authority will ask for if they ever question the class. **Checklist for Step 2:** Annex VIII walked rule by rule, the applicable rule identified, the Class I classification documented with rationale, the Is/Im/Ir sub-category status confirmed (standard, sterile, measuring, or reusable surgical instrument), and the conformity assessment route selected accordingly under Article 52(7). ## Step 3 — Build a QMS proportionate to the risk class Article 10(9) of Regulation (EU) 2017/745 requires every manufacturer to establish, document, implement, maintain, keep up to date, and continually improve a quality management system that ensures compliance in a manner proportionate to the risk class and type of device. For Class I, the harmonised standard that provides presumption of conformity with the QMS obligations is EN ISO 13485:2016+A11:2021. Compliance with that standard, where it applies, gives presumption of conformity with the matching MDR QMS requirements. "Proportionate" is the word founders get wrong. It does not mean "as small as possible." It means the QMS covers every required process at a depth that matches the risk. For a Class I standard device, a focused QMS run by a small team with external PRRC coverage under Article 15 is legitimate. A QMS made of templates from another company with the names changed is not. The test is whether the documented processes match the processes the company actually runs. **Checklist for Step 3:** QMS scope statement written, document control procedure in place, design and development procedure in place, purchasing and supplier controls in place, production and service controls in place, CAPA procedure in place, internal audit procedure in place, management review procedure in place, training records in place, and the QMS scoped against EN ISO 13485:2016+A11:2021. ## Step 4 — Compile the technical documentation per Annexes II and III Annex II of Regulation (EU) 2017/745 sets out the technical documentation for the device itself. Annex III sets out the technical documentation on post-market surveillance. Both apply to Class I. The Class I file can be proportionate — shorter, lighter, with less sampling than a Class III file — but every section of Annex II must be addressed. The Annex II structure is specific: device description and specification, information to be supplied by the manufacturer, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management, product verification and validation. Annex III adds the post-market surveillance plan. A Class I file that skips the GSPR checklist or the benefit-risk analysis is not a light file. It is an incomplete file. **Checklist for Step 4:** device description compiled, design history of the device captured, manufacturing process described, GSPR checklist completed with traceability to evidence, risk management file per EN ISO 14971:2019+A11:2021 in place, verification and validation records collected, and the PMS plan per Annex III drafted. ## Step 5 — Complete the clinical evaluation Article 61 of Regulation (EU) 2017/745 requires a clinical evaluation for every medical device, including Class I. For most Class I devices, the clinical evaluation can be based on a literature review and clinical data from equivalent devices rather than a new clinical investigation, and the resulting clinical evaluation report can be proportionally shorter than a Class III CER. "Shorter" is not "absent." The CER must exist, must be written down, and must be kept up to date throughout the lifecycle. Annex XIV sets out the methodology. The evaluation identifies and appraises available clinical data, assesses whether the data is sufficient to demonstrate conformity with the relevant GSPRs, and concludes with a risk-benefit statement. For a typical low-risk Class I device with a literature base, this can be a compact but complete document. For a Class I device with no prior literature, the evaluation work is larger. **Checklist for Step 5:** clinical evaluation plan written, literature search documented with search strategy and inclusion criteria, data appraised and analysed, equivalence considerations addressed where relevant, clinical evaluation report signed and dated, and the post-market clinical follow-up plan scoped against Annex XIV Part B. ## Step 6 — Finalise labelling and the instructions for use Annex I Chapter III of Regulation (EU) 2017/745 sets out the requirements for the information supplied with the device, including both labelling and instructions for use. Class I devices are not exempt from these requirements. The label must carry the manufacturer name and address, the UDI where applicable, the device identification, the batch or serial number, any necessary warnings and precautions, and the CE marking. The instructions for use must cover intended purpose, intended users, warnings, precautions, and any other information needed for safe use. This step runs in parallel with the technical documentation and the clinical evaluation, because the labelling text and the IFU content have to reflect the intended purpose from Step 1 and the risk controls from the risk management file in Step 4. Inconsistencies between the label, the IFU, the website, and the promotional materials are one of the fastest ways to invalidate the intended purpose a competent authority eventually reads. Keep them consistent from the start. **Checklist for Step 6:** label content complete per Annex I Chapter III, IFU complete per Annex I Chapter III, UDI assigned, all mandatory symbols included, language versions prepared for the target markets, and cross-check of intended purpose language between label, IFU, website, and promotional materials completed. ## Step 7 — Draw up the EU declaration of conformity under Annex IV and Article 19 Article 19 of Regulation (EU) 2017/745 requires the manufacturer to draw up an EU declaration of conformity stating that the device meets the requirements of the Regulation. Annex IV sets out the minimum content: manufacturer name and address, authorised representative where applicable, name and product reference of the device, 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, notified body information where applicable (not applicable for Class I standard), and the date, place, and signature of the person authorised to sign on behalf of the manufacturer. The declaration is the legal act that completes the conformity assessment under Article 52(7) for standard Class I devices. Signing it is not a ceremonial moment. It is the manufacturer assuming personal legal responsibility for everything in the technical file, the QMS, the clinical evaluation, and the labelling. The declaration has to be accurate on the day it is signed, and it has to stay accurate as the device, the regulation, and the standards evolve. **Checklist for Step 7:** Annex IV content template completed with all required fields, cross-references to the technical documentation verified, standards applied listed with their current editions including EN ISO 13485:2016+A11:2021, the signatory identified, the declaration signed and dated, and the original filed in the QMS document control system. ## Step 8 — Register the manufacturer and the device in EUDAMED Under the MDR, manufacturers must register themselves, their devices, and the UDI-DI information in the European Database on Medical Devices (EUDAMED). The operational status of individual EUDAMED modules has evolved over time, and the obligation to register applies to the extent the modules are functional. A Class I manufacturer's practical step here is to register in the actor module, obtain the SRN (Single Registration Number), register the device in the UDI module to the extent required, and keep the data current. **Checklist for Step 8:** manufacturer registered in EUDAMED actor module, SRN obtained and documented, device registered in the UDI module to the extent applicable, UDI-DI assigned and documented, and the registration records filed with the declaration of conformity. ## Step 9 — Affix the CE marking and place on the market Once the declaration of conformity has been drawn up under Annex IV, the manufacturer affixes the CE marking to the device in accordance with the general principles set out in the Regulation and places the device on the market. The CE marking signals that the manufacturer has completed the conformity assessment procedure appropriate to the class — for standard Class I, that procedure is Article 52(7) plus Annex IV, with no Notified Body number next to the CE mark because no Notified Body certificate is issued for the device itself. From the moment the first device is placed on the market, the manufacturer's obligations continue. The PMS system under Article 83 starts running. Vigilance obligations under Articles 87 to 92 apply. The technical documentation must be kept available for competent authorities for at least ten years after the last device has been placed on the market under Article 10(8). The declaration of conformity is not the end of the work. It is the start of the post-market phase. **Checklist for Step 9:** CE marking affixed to the device, label and packaging carry the CE marking correctly, declaration of conformity archived, PMS plan activated, vigilance procedure active, and the technical documentation retention clock started under Article 10(8). ## The Subtract to Ship angle The Subtract to Ship methodology treats the Class I nine-step checklist as the base case of the Classification Pass and the Operations Pass running together. Every step traces to a specific MDR obligation. Nothing in the checklist is optional. Nothing in the checklist is ceremonial. And — this is the subtraction — nothing beyond the checklist is required either. The bloat that shows up in Class I projects comes from adding steps that only apply at higher classes: a full Notified Body QMS audit, a mandatory PSUR, a clinical investigation on a device where literature and equivalence suffice, a technical file structured for Class III per-device review. These additions are not compliance. They are either misremembered requirements or recycled consultancy proposals from higher-class projects. Cut them. Walk the nine steps. Ship. For the full methodology, see [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr). ## Reality Check — Where do you stand on the Class I checklist? 1. Is your intended purpose written down in a single controlled sentence, stable, and cross-checked against the Article 2(1) definition of a medical device? 2. Have you walked Annex VIII rule by rule and documented why Class I applies, including confirmation that you are standard Class I and not Is, Im, or Ir? 3. Do you have a QMS proportionate to Class I in place, aligned with EN ISO 13485:2016+A11:2021, and reflecting the processes your company actually runs? 4. Is your technical documentation organised per Annex II with every section addressed, including a GSPR checklist and a benefit-risk analysis? 5. Is your PMS plan drafted per Annex III and ready to activate on the day you place the first device on the market? 6. Does your clinical evaluation report exist in writing, referencing Article 61 and Annex XIV, with the evidence pathway (literature, equivalence, or investigation) documented? 7. Are your labelling and instructions for use complete per Annex I Chapter III and consistent with your intended purpose across every channel (label, IFU, website, promotional materials)? 8. Is your EU declaration of conformity drafted per Annex IV and Article 19, with every required field populated and the standards listed at their current editions? 9. Have you registered in EUDAMED and obtained your SRN? 10. Could you produce the complete file (intended purpose, classification rationale, QMS, technical documentation, clinical evaluation, labelling, declaration of conformity, EUDAMED registration, PMS plan) within a reasonable time if a competent authority asked for it next week? ## Frequently Asked Questions **What is the legal basis for Class I self-certification?** Article 52(7) of Regulation (EU) 2017/745 is the legal basis. It provides that manufacturers of Class I devices other than those placed on the market in sterile condition, with a measuring function, or consisting of reusable surgical instruments shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III. The declaration is drawn up in the format of Annex IV. **How long does the Class I conformity assessment procedure take?** For a well-scoped Class I project with a stable intended purpose and a small team, the nine steps can move from start to declaration of conformity in a matter of months rather than years. The critical path is usually the QMS maturity and the clinical evaluation, not the declaration itself. Adding a clinical investigation extends the timeline significantly; keeping the evaluation literature-based and equivalence-based where legitimate keeps it compact. **Does a Class I device need a Notified Body at all?** For standard Class I devices (non-sterile, non-measuring, non-reusable-surgical-instrument), no. The manufacturer self-declares conformity under Article 52(7) and Annex IV. For Class Is (sterile), Class Im (measuring function), and Class Ir (reusable surgical instruments), a Notified Body is involved for the specific aspect that triggered the sub-category, but not for the full QMS or the full technical documentation. **Can the Class I technical file be shorter than a Class IIa file?** Yes, proportionately, but every section of Annex II must still be addressed. Annex II is a content list, not a depth requirement. The Class I file can treat each section at a depth that matches Class I risk — shorter risk analyses, lighter verification and validation evidence, a compact literature-based clinical evaluation — but skipping any section of Annex II is not permitted regardless of class. **What happens if the declaration of conformity is drawn up incorrectly?** The declaration is a legal instrument. If it is incorrect (wrong class, wrong annex reference, missing required content under Annex IV, or claims that are not supported by the underlying technical file), the device is not properly placed on the market. Competent authorities can require correction, restrict placing on the market, or in the case of false claims, pursue further action. The declaration deserves a careful review before signing. **Who can sign the EU declaration of conformity for a Class I device?** The signatory is a person authorised to sign on behalf of the manufacturer. In practice this is usually a managing director, a quality manager, or a person explicitly designated by the company's management. The signatory does not need to be the PRRC under Article 15, but the declaration should be prepared with the PRRC's involvement so that the regulatory accuracy is verified before signing. ## Related reading - [Self-Certification Under MDR: CE Marking Without a Notified Body](/blog/self-certification-under-mdr) — the companion post on what self-certification means in practice. - [MDR Annex IV: The EU Declaration of Conformity Explained](/blog/mdr-annex-iv-declaration-of-conformity) — the deep dive on the declaration itself. - [Class I Medical Devices Under MDR: What Startups Need to Know](/blog/class-i-medical-devices-under-mdr) — the conceptual post on what Class I means and when it applies. - [Choosing the Right Conformity Assessment Route for Your Startup's Device Class](/blog/choosing-conformity-assessment-route-startup) — the route decision across all classes. - [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) — the methodology behind the checklist. ## Sources 1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10 (general obligations of manufacturers, including 10(8) on technical documentation retention and 10(9) on QMS), Article 19 (EU declaration of conformity), 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), Annex VIII (classification rules, including Rule 1 context). Official Journal L 117, 5.5.2017. 2. MDCG 2021-24 — Guidance on classification of medical devices, October 2021. 3. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes. --- *This post is part of the Device Classification & Conformity Assessment series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The Class I checklist is the lightest conformity assessment procedure in the Regulation and the one most frequently mishandled because founders mistake "no Notified Body" for "no structure." Walking the nine steps in order, at Class I depth, is the difference between a defensible file and a stack of paper that does not survive first contact with a competent authority.* --- *This post is part of the [Device Classification & Conformity](https://zechmeister-solutions.com/en/blog/category/classification) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*