EU MDR Class I Device Compliance Guide

In 2024, the European Commission acknowledged that only 45 Notified Bodies had been designated under the MDR — down from roughly 80 under the previous Medical Device Directive. The resulting bottleneck has delayed recertification across all device classes, and several EU Member States have reported that up to 20% of Class I manufacturers had not fully transitioned their technical documentation from MDD to MDR format during spot checks. A non-sterile Class I device may not need a Notified Body, but that self-declaration must still be built on the new regulation's structure — and outdated documentation is treated the same as no documentation during a competent authority audit.

Under the EU Medical Device Regulation (MDR — Regulation [EU] 2017/745), all medical devices placed on the European market require a Declaration of Conformity. Class I devices are the lowest-risk category but the documentation burden is far from trivial. On the Sustalium platform, the area where we see Class I manufacturers submit incomplete documentation most frequently is the new clinical evaluation and post-market surveillance requirements — obligations that simply did not exist under MDD.

MDR Class I: What You Need to Know

The MDR classifies medical devices into four risk classes: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk). Class I devices include products like:

• Non-sterile bandages, gauze, and wound dressings
• Examination gloves (non-sterile)
• Stethoscopes
• Hospital beds and patient hoists
• Reusable surgical instruments
• Otoscopes and ophthalmoscopes

Subcategories of Class I

Subcategory	Notified Body Required?	Examples
Class I (general)	No — self-declaration	Non-sterile bandages, stethoscopes, hospital beds
Class Is (sterile)	Yes — limited to sterilization aspects	Sterile gauze, sterile syringes
Class Im (measuring function)	Yes — limited to metrology aspects	Graduated measuring cups, thermometers
Class Ir (reusable surgical)	Yes — limited to reprocessing aspects	Reusable scalpels, reusable forceps

If your Class I device is non-sterile, has no measuring function, and is not a reusable surgical instrument, you can self-declare conformity without Notified Body involvement. This does not mean the compliance burden is light — it means you are solely responsible for ensuring and documenting full MDR compliance.

Step 1: Verify Classification and Scope

Before drafting your Declaration of Conformity, confirm that your device genuinely qualifies as Class I under MDR Annex VIII classification rules. The MDR classification system is rules-based:

• Rule 1: Non-invasive devices → Class I (unless another rule applies)
• Rule 2: Non-invasive devices for channeling or storing body liquids → Class IIa or higher
• Rule 5: Invasive devices for body orifices → Class I, IIa, or IIb

If your device is sterile (Class Is), has a measuring function (Class Im), or is a reusable surgical instrument (Class Ir), you cannot self-declare — you must involve a Notified Body for at least those specific aspects. Manufacturing Class I devices under the wrong classification exposes you to MDR enforcement action, including product withdrawal from the EU market.

Step 2: Compile Technical Documentation (Annex II)

MDR Annex II specifies the technical documentation that must support your Declaration of Conformity. For Class I devices, this includes:

1. Device description and specification: Intended purpose, intended users, patient population, list of variants, and design drawings.
2. Manufacturing information: Design and manufacturing processes, quality control procedures, and sterilization validation (if applicable).
3. General Safety and Performance Requirements (GSPR): A checklist demonstrating conformity with every applicable requirement in MDR Annex I.
4. Benefit-risk analysis: A documented analysis showing that the benefits of the device outweigh any residual risks.
5. Clinical evaluation: Clinical evidence supporting the device's safety and performance — this is a major change from MDD, where clinical evaluation for low-risk devices was less rigorous.
6. Labeling: Labels, instructions for use (IFU), and packaging in the official languages of the Member States where the device will be sold.

Step 3: Issue the Declaration of Conformity

The Declaration of Conformity is the legal document through which you assume full responsibility for your device's compliance. Under MDR Annex IV, your DoC must contain:

• Manufacturer's name, registered trade name, and address
• A statement that the DoC is issued under the sole responsibility of the manufacturer
• The Basic UDI-DI (Unique Device Identification — Device Identifier)
• Product and trade name, product code, and intended purpose
• Device risk class (Class I)
• A statement confirming conformity with MDR (EU) 2017/745
• Reference to any applicable common specifications
• Place and date of issue
• Name and signature of the authorized person

Step 4: Register with EUDAMED

All Class I device manufacturers must register their devices in the European Database on Medical Devices (EUDAMED). Registration includes:

• Actor registration (manufacturer, authorized representative, importer)
• UDI device registration with Basic UDI-DI
• Submission of the Declaration of Conformity

Without EUDAMED registration, your device cannot be legally placed on the EU market, even with a valid DoC.

The Authorized Representative Requirement

If your company is based outside the EU, you must appoint an EU Authorized Representative established in a Member State. This representative must verify your Declaration of Conformity and technical documentation, register your device in EUDAMED, and act as the contact point for EU competent authorities. Without one, your devices cannot legally enter the EU.

Step 5: Post-Market Surveillance (PMS)

The MDR introduced mandatory post-market surveillance for all device classes, including Class I. You must:

• Maintain a PMS plan proportionate to the device risk class
• Collect and analyze post-market data (complaints, adverse events, clinical feedback)
• Issue Periodic Safety Update Reports (PSURs) for Class I devices — though less frequent than for higher classes
• Report serious incidents to competent authorities via the vigilance system within the required deadlines

How Sustalium Supports MDR Class I Compliance

Managing MDR technical documentation, clinical evaluations, and EUDAMED registration across multiple product variants in spreadsheets and static Word documents is error-prone and unsustainable.

Sustalium's EU MDR compliance platform centralizes your Class I device documentation:

• Structured DoC Generator: Enter your device data once and Sustalium generates a complete MDR Annex IV-compliant Declaration of Conformity, mapped to your GSPR checklist and clinical evaluation.
• GSPR Checklist Automation: A structured Annex I checklist ensures you don't miss a single General Safety and Performance Requirement.
• EUDAMED-Ready Data Export: Sustalium structures your UDI and device data in EUDAMED-compatible formats for faster registration.
• Integrated Technical File Management: Link your risk assessments, clinical evaluation reports, test reports, and labeling into a single audit-ready dossier.

Generate Your MDR Class I DoC Today

Don't risk EU market exclusion because of outdated or incomplete medical device documentation. Build a complete, audit-ready MDR Class I Declaration of Conformity in minutes.

With Sustalium, there are no monthly subscriptions. Generate your MDR DoC for just €10 per document.

Start Your MDR Declaration Now →

Frequently Asked Questions

Can I still use my MDD Class I Declaration of Conformity?

No. Since the MDR fully replaced the MDD (Directive 93/42/EEC), all Class I devices must now be declared under MDR (EU) 2017/745. MDD-based documentation is no longer valid for devices placed on the EU market.

Do Class I devices require a Notified Body certificate?

General Class I devices (non-sterile, non-measuring, non-reusable surgical) do not require a Notified Body certificate and can be self-declared. However, if your device is sterile (Class Is), has a measuring function (Class Im), or is a reusable surgical instrument (Class Ir), a Notified Body must be involved — though only for the relevant aspect.

What is a Basic UDI-DI and do I need one for Class I?

Yes. All medical devices under MDR require a Basic UDI-DI, which is the primary device identifier used in EUDAMED. It is different from the UDI-DI that appears on the device label. You obtain your Basic UDI-DI from an issuing entity (such as GS1 or HIBCC) and include it in your DoC and EUDAMED registration.

---

---

Last updated: July 13, 2026