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Class I Medical Device (Class 1) under EU MDR

A Class I medical device is the lowest-risk class under EU MDR 2017/745. Most Class I devices are non-invasive, or invasive only for a short time through a body opening. The manufacturer can CE mark a standard Class I device without a Notified Body, by preparing Annex II and III technical documentation and signing an EU declaration of conformity under Article 52(7). Sterile (Is), measuring (Im) and reusable surgical (Ir) Class I devices do need a Notified Body for those aspects. I3CGLOBAL confirms the class, prepares the full self-declaration file and registers manufacturers and devices in EUDAMED from offices in India, Europe and the USA.

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Classification rules

Which Rules Make a Device Class I?

A device is Class I when the Annex VIII classification rules point to Class I and no stricter rule applies. If more than one rule applies, the strictest one decides the class (Annex VIII, section 3.5).

Rule When the result is Class I
Rule 1 Non-invasive devices, unless another rule gives a higher class.
Rule 2 Non-invasive devices for channelling or storing that do not meet the IIa or IIb conditions of the rule.
Rule 4 Non-invasive devices that contact injured skin and act as a mechanical barrier, for compression or to absorb exudates.
Rule 5 Invasive devices used through a body orifice for a transient period (under 60 minutes). Short-term use in the oral cavity up to the pharynx, the ear canal up to the eardrum or the nasal cavity is also Class I.
Rule 6 Reusable surgical instruments. These are Class Ir, see the Class Ir page.
Rule 11 Software that does not provide information for diagnosis or therapy and does not monitor physiological processes.
Rule 13 All other active devices not classified by Rules 9 to 12.

The class depends on the intended purpose stated by the manufacturer, not on the product name. The same product can be Class I for one claim and Class IIa for another.

Examples

What Are Examples of Class I Medical Devices?

The examples below are typical. Always confirm the class against your own intended purpose and the classification rules.

Device (typical) Rule Why it is usually Class I
Wheelchairs and walking aids Rule 1 Non-invasive, and contact intact skin only.
Non-sterile bandages and compression dressings Rule 4 Act as a mechanical barrier or provide compression.
Stethoscopes (non-active) Rule 1 Non-invasive with no energy supply.
Non-sterile examination gloves Rule 1 / Rule 5 Used on intact skin or for transient use in a body orifice.
Wooden tongue depressors (non-sterile) Rule 5 Transient invasive use in the oral cavity.
Spectacle frames and non-corrective reading aids Rule 1 Non-invasive.
Hospital beds without active functions Rule 1 Non-invasive. Electrically powered beds fall under Rule 13 and are still usually Class I.

Watch the sub-classes: if any of these devices is supplied sterile, it becomes Class Is. If it has a measuring function, it becomes Class Im. Both need a Notified Body.

CE marking route

How Do You CE Mark a Class 1 Medical Device?

A standard Class I device follows the self-declaration route in Article 52(7) of the MDR. No Notified Body certificate is issued. The manufacturer remains fully responsible for compliance.

  1. Confirm it is a medical deviceCheck that the product meets the medical device definition in Article 2(1), or is an Annex XVI product.
  2. Confirm Class I and rule out Is, Im and IrApply all Annex VIII rules. Record the rule used and your reasoning.
  3. Set up the quality management systemImplement a QMS that meets Article 10(9), usually to EN ISO 13485, including risk management to EN ISO 14971. For standard Class I devices no Notified Body audits the QMS and ISO 13485 certification is voluntary, but the system must exist, be documented and be followed.
  4. Meet the general safety and performance requirementsComplete a GSPR checklist against Annex I and gather test evidence, such as biocompatibility, electrical safety or usability.
  5. Perform the clinical evaluationWrite a clinical evaluation plan and report as required by Article 61 and Annex XIV.
  6. Prepare the technical documentationCompile the Annex II and Annex III files, including the post-market surveillance plan.
  7. Appoint the required peopleName a person responsible for regulatory compliance (Article 15). Micro and small enterprises need not employ the PRRC but must have one permanently and continuously at their disposal (Article 15(2)). Manufacturers outside the EU appoint an EU authorised representative (Article 11).
  8. Assign UDI and register in EUDAMEDAssign a Basic UDI-DI and UDI-DI, and register the actor and the device in EUDAMED. Use of the actor, UDI/device, certificate and market surveillance modules has been mandatory since 28 May 2026. Devices already on the market before that date must be registered by 28 November 2026; devices placed on the market after it must be registered before the first unit is placed on the market.
  9. Sign the EU declaration of conformityDraw up the declaration with the content listed in Annex IV.
  10. Affix the CE markPlace the CE mark visibly, legibly and indelibly on the device or its packaging, with the label and instructions for use.

Documentation

What Technical Documentation and Clinical Evidence Does Class I Need?

Self-declaration does not mean less documentation. A competent authority can ask for the full file at any time, and the file must be ready to share.

Annex II technical file

Device description, intended purpose, labels and IFU, design and manufacturing information, GSPR checklist, risk management file and verification and validation results.

Annex III PMS file

A post-market surveillance plan, and a PMS report under Article 85 that you update when necessary.

Clinical evaluation report

Clinical data from literature, equivalent devices or your own use, assessed against Annex XIV.

Vigilance and corrective action

Procedures to report serious incidents and field safety corrective actions, and to withdraw or recall a non-compliant device.

Keep the technical documentation for at least 10 years after the last device is placed on the market. Our team prepares MDR technical files and clinical evaluation reports for Class I manufacturers worldwide.

How long does Class I CE marking take and what does it cost?

How long Class I CE marking takes depends mainly on how complete the technical documentation and clinical evaluation already are, because no Notified Body review is involved. Manufacturers with an existing ISO 13485 QMS and test reports can usually complete the file far faster than first-time manufacturers who still need testing, a clinical evaluation report and a QMS. Consulting fees depend on the same factors: see our MDR CE marking proposal request, clinical evaluation report fees and EU authorised representative cost.

Borderline cases

What Are Common Class I Classification Mistakes?

  • Calling a reusable instrument Class I. Reusable surgical instruments, such as scalpel handles, forceps and retractors, are Class Ir and need a Notified Body for reprocessing aspects.
  • Forgetting sterility. A non-sterile product that is later sold sterile becomes Class Is.
  • Ignoring a measuring scale. Adding graduations to measure a dose or body parameter can make the device Class Im.
  • Wound claims. A dressing that claims to manage the wound micro-environment is usually Class IIa, and one for deep wounds healing by secondary intent is Class IIb (Rule 4).
  • Software claims. An app that supports diagnosis or treatment decisions is at least Class IIa under Rule 11.
  • Accessories. Accessories are classified in their own right and may be in a higher class than the main device.

Not self-declared: Class Is, Class Im and Class Ir devices cannot use the Class I self-declaration route. A Notified Body must assess the sterile, measuring or reuse aspects before CE marking.

Compare

How Does Class I Compare with Other Classes?

Class I is the only class under the MDR that can be CE marked without a Notified Body; every other class, and the Is, Im and Ir sub-classes, needs one.

Class Notified Body Main difference from Class I
Class Is Yes, sterility only Supplied sterile
Class Im Yes, metrology only Has a measuring function
Class Ir Yes, reuse aspects only Reusable surgical instrument
Class IIa Yes Medium risk, PSUR every 2 years
Class IIb Yes Medium to high risk, PSUR yearly
Class III Yes, full review Highest risk, clinical investigation usually required

For a side-by-side view of every class, see Class I vs IIa vs IIb vs III.

Work with I3CGLOBAL

Get Your Class I Device CE Marked

I3CGLOBAL has completed 300+ CE certifications, with offices in India, Europe and the USA. We confirm your class and prepare the full self-declaration file.

  • Class I, Is, Im or Ir confirmation
  • Technical file and GSPR checklist
  • Clinical evaluation report
  • EU authorised representative and EUDAMED registration

Request your proposal

Share your device details and we will prepare a Class I CE marking proposal.

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FAQs

Class I Medical Device: Frequently Asked Questions

Is Class 1 the same as Class I?

Yes. The MDR uses the Roman numeral Class I. Class 1 is the same class written with an ordinary number. Both names refer to the lowest-risk group of medical devices under Annex VIII of EU MDR 2017/745.

Does a Class I medical device need a Notified Body?

No, a standard Class I device does not. The manufacturer prepares the technical documentation and signs the EU declaration of conformity. A Notified Body is needed only for Class Is (sterile), Class Im (measuring function) and Class Ir (reusable surgical instruments), and only for those specific aspects.

Do Class I devices need a clinical evaluation?

Yes. Article 61 of the MDR requires a clinical evaluation for every device class. For many Class I devices the evaluation can rely on literature and data from equivalent or well-established devices, but it must be documented in a clinical evaluation report.

Do Class I devices need a quality management system?

Yes. Article 10(9) requires every manufacturer to have a quality management system proportionate to the risk class and type of device. Most manufacturers use EN ISO 13485. For standard Class I devices, no Notified Body audits the system.

Do Class I devices need to be registered in EUDAMED?

Yes. Class I manufacturers must register as actors and register their devices and UDI data in EUDAMED. Use of these modules has been mandatory since 28 May 2026, with a deadline of 28 November 2026 for devices already on the market. Manufacturers outside the EU need an EU authorised representative before they can register.

What happens if my Class I device is reclassified to a higher class?

You can no longer self-declare. If a design change, new claim or new intended purpose moves the device into Class Is, Im, Ir, IIa or higher, a Notified Body must assess it before you can place the changed device on the market.

When must a Class I device be registered in EUDAMED?

Since 28 May 2026 the EUDAMED actor, UDI/device, certificate and market surveillance modules are mandatory. Class I devices already on the EU market before that date must be registered by 28 November 2026. A new Class I device must be registered before the first unit is placed on the market.

Does a Class I device need an EU authorised representative?

Yes, if the manufacturer is established outside the EU. Article 11 requires a written mandate with an EU authorised representative before the device is placed on the market, and the representative’s name and address must appear on the label.

Is an EU MDR Class I device the same as a US FDA Class I device?

No. The classification systems are different. A device that is Class I under the MDR may be Class I or Class II under FDA rules, and the FDA route (exemption, 510(k) or other) must be checked separately.

Is Class I self-certification the same as self-declaration?

Yes. Both terms describe the Article 52(7) route in which the manufacturer, not a Notified Body, declares conformity by signing the EU declaration of conformity.

Sources

Sources and Regulatory References

The information on this page is based on the following official texts and guidance. Always check the current consolidated version before relying on a reference.