FAQEU

EU MDR FAQ Accessories

Under the EU MDR, an accessory can be regulated even when it is not itself a medical device, if the manufacturer intends it to be used with one or more particular medical devices to enable or directly assist their medical functionality.

Use this FAQ to document the intended-purpose link, accessory classification, technical documentation, UDI, PMS, and retained evidence.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Questions
2

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Primary sources
3

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

An article is an EU MDR accessory when the manufacturer's intended purpose ties it to one or more particular medical devices and it specifically enables use of the device, or specifically and directly assists the device's medical functionality. Once qualified, the accessory is treated as a device for MDR purposes and is classified in its own right.

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2 of 2 questions
Question 1

When is an accessory regulated as a medical device accessory under the EU MDR?

The MDR accessory test is not whether the article looks like a medical device. It is whether the manufacturer intends it to be used together with one or more particular medical devices to enable those devices to be used for their intended purpose, or to specifically and directly assist their medical functionality.

That intended-purpose link should be visible in the retained evidence: labels, instructions for use, marketing claims, compatibility statements, interface specifications, risk analysis, and any decision explaining why the product is or is not an MDR accessory.

  • Record the particular device or device family the article supports and the intended medical function it enables or assists.
  • Classify the accessory separately from the device with which it is used; Annex VIII states that accessories are classified in their own right.
  • If the product is qualified as an accessory, keep MDR technical documentation, clinical evaluation evidence where applicable, UDI assignments, EU declaration of conformity data, registration evidence, and PMS inputs proportionate to its class and risk.
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Check accessory qualification and evidence

Review intended purpose, supported device relationship, accessory classification, UDI, technical documentation, and PMS evidence before changing claims, labels, interfaces, or market release plans.

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Question 2

Accessory evidence to retain

A useful accessory file should let a reviewer see the product boundary, the medical device relationship, and the MDR duties triggered by the conclusion. Keep the rationale close to the technical file rather than as a standalone label decision.

Reopen the decision when intended purpose, compatible devices, claims, software or firmware, interfaces, packaging, UDI grouping, supplier evidence, risk controls, or PMS findings change.

  • Qualification: why the article is a medical device, an accessory, outside MDR, or part of another configuration.
  • Classification: Annex VIII rule applied to the accessory, risk class, and notified-body involvement where that route follows from the classification.
  • Lifecycle duties: technical documentation, EU declaration of conformity data, UDI and registration records, clinical evaluation support where applicable, PMS plan inputs, complaint handling, vigilance triggers, and corrective-action records.
Citations
Primary sources

References and citations

MDCG 2022-7 - Questions and answers on the UDI system
health.ec.europa.eu
Referenced sections
  • Supports UDI and Basic UDI-DI evidence expectations for documentation, certificates, declarations of conformity, SSCP, and PSUR references.
"declaration of conformity, technical documentation"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • Grounds manufacturer duties for technical documentation, UDI, registration, EU declaration of conformity, classification, and PMS.
"technical documentation"
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