WorkflowEU

EU MDR qualification workflow

Use this workflow before MDR classification. It turns intended purpose, claims, labels, instructions, software functions, accessories, Annex XVI products, IVD interfaces, medicinal interfaces, and borderline evidence into a recorded scope decision.

The output is a qualification rationale that can be handed to classification, notified-body selection, technical documentation, and conformity-route planning.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Sections
4

Structured answer sets in this page tree.

Primary sources
3

Cited legal and guidance references.

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

EU MDR qualification starts with the manufacturer's intended purpose and the product evidence around it. Decide whether the product is a medical device, an accessory, a covered Annex XVI product without an intended medical purpose, an IVD-related product, a medicinal-product interface, or outside MDR scope before applying Annex VIII classification rules.

Section 1

Collect the qualification evidence first

Start by freezing the facts that define the intended purpose. Under the MDR, intended purpose is read from manufacturer-supplied data on the label, instructions for use, promotional or sales materials or statements, and the clinical evaluation. A qualification file should therefore capture the live product claim set before anyone chooses a class or conformity route.

  • Collect the product description, variants, configurations, components, accessories, software modules, data sources, user groups, patient or consumer populations, markets, and economic-operator role.
  • Copy the intended purpose wording from draft labels, instructions for use, package copy, app-store text, sales decks, website claims, support scripts, and clinical-evaluation assumptions.
  • List each function separately when software is involved: data collection, transformation, analysis, alarm generation, diagnosis or therapy support, monitoring, device control, device influence, communication, storage, or administrative workflow.
  • Record whether the product is supplied alone, in combination, as a system, as a procedure pack, as a component of another product, or as a replacement part intended to maintain or restore an existing device.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
Defines intended purpose by reference to the manufacturer's label, instructions for use, promotional or sales materials or statements, and clinical evaluation.
Section 2

Decide whether the product is a device, accessory, or Annex XVI product

Apply MDR Article 2 before classification. A product qualifies as a medical device only when its intended use fits one of the listed medical purposes for human beings and its principal intended action is not achieved by pharmacological, immunological, or metabolic means. The workflow should also test accessory status and Annex XVI status because those outcomes still pull the product into MDR controls.

  • Device test: map the intended purpose to diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; injury or disability diagnosis, monitoring, treatment, alleviation or compensation; anatomy or physiological or pathological process investigation, replacement or modification; in vitro specimen-derived information; conception control or support; or cleaning, disinfection or sterilisation of covered devices.
  • Principal-action test: if the principal intended action is pharmacological, immunological, or metabolic, route the question to the medicinal-product interface instead of treating it as a simple MDR qualification.
  • Accessory test: decide whether the article is not itself a medical device but is intended to be used with one or more particular medical devices to enable their intended purpose or directly assist their medical functionality.
  • Annex XVI test: identify products without an intended medical purpose that MDR Article 1 brings into scope when common specifications apply, and flag dual-purpose products because MDR Article 1 requires both medical-purpose and non-medical-purpose requirements to be fulfilled cumulatively.
  • Borderline test: if the facts do not clearly resolve scope, keep a written rationale and identify whether the uncertainty concerns MDR, IVDR, medicinal products, cosmetics, food, biocides, human tissues or cells, or another product framework.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
Provides the medical-device definition, accessory definition, Annex XVI scope rule, dual-purpose rule, exclusions, and Commission borderline-determination mechanism.
Section 3

Separate IVD, medicinal, and product-safety interfaces only where the facts require it

Do not turn every qualification review into a survey of unrelated regimes. Use interface checks only where the collected evidence shows a real boundary question: specimen-derived information, medicinal substance action, a drug-delivery combination, or product-safety law overlap.

  • IVD interface: if the product or software provides information from in vitro examination of specimens derived from the human body, decide whether the IVDR governs the IVD part or the product as an IVD-related product before continuing under MDR.
  • MDR device with IVD part: when a device incorporates an IVD as an integral part, keep the MDR qualification for the device and record that IVDR requirements apply to the IVD part.
  • Medicinal-product interface: when a product combines a medicinal product or substance and a device, record the principal mode of action. If a substance that would be a medicinal product acts only ancillary to the device, document the MDR route and the medicinal-substance consultation trigger for later conformity planning.
  • Drug-administration interface: if the article is intended to administer a medicinal product, record whether the device and medicinal product are marketed as a single integral, non-reusable product intended exclusively for that combination.
  • Product-safety interface: for non-device products, replacement parts, or general-purpose software, document why MDR does not apply and hand the item to the relevant product-safety, machinery, software, cosmetic, food, biocidal, or contractual review only when the grounding facts support that handoff.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
Grounds MDR exclusions and interfaces for IVDR products, medicinal products, integral IVD parts, medicinal substances with ancillary action, and medicinal-product administration devices.
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Grounding source for the IVDR interface where software or a product is driven by in vitro diagnostic information rather than MDR device information.
Section 4

Record the rationale and hand off to classification and conformity planning

The qualification output should be a short, inspectable rationale rather than a meeting note. It should show the collected claims, the Article 2 or Article 1 path taken, the exclusions considered, the sources used, the unresolved assumptions, and the exact point where classification begins.

  • State the result as one of these outcomes: MDR medical device, MDR accessory, MDR Annex XVI product, MDR device with IVD part, medicinal-product route with device-part requirements, IVDR route, outside MDR scope, or unresolved borderline issue.
  • For MDR outcomes, hand the file to Annex VIII classification with intended purpose, duration, invasiveness, active-device status, software independence or device influence, medicinal-substance presence, tissues or cells, sterile status, measuring function, and Annex XVI status already identified.
  • For software, decide whether it drives or influences another device, is independent and classified in its own right, or is general-purpose or administrative software outside the device definition.
  • For non-Class I or otherwise notified-body-involved routes, carry forward the qualification rationale into notified-body scope checks, technical-documentation planning, clinical-evidence planning, UDI planning, and declaration-of-conformity planning.
  • Escalate to regulatory counsel or competent-authority strategy when the rationale depends on a borderline interpretation, principal mode of action, or another EU framework that the qualification file cannot resolve from the available evidence.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
Grounds the handoff from qualification to Annex VIII classification, including intended-purpose-based rules, separate classification of accessories, and software classification rules.
European Commission - notified bodies for medical devices
Commission source for the notified-body context used when a qualified and classified MDR product needs conformity-assessment route planning.
Recommended next step

Turn qualification into a defensible MDR scope record

Use the qualification rationale to align product claims, software functions, labels, instructions, regulatory interfaces, classification inputs, and conformity-route planning before launch or major product change.

Research workflow
Open Research Copilot

Resolve MDR scope, interface, and classification questions with cited outputs.

Explore next step
Talk to Sorena
Talk through MDR qualification

Review intended purpose, claims, software functions, borderline issues, and conformity-route inputs.

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Primary sources

References and citations

Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • Grounds the handoff from qualification to Annex VIII classification, including intended-purpose-based rules, separate classification of accessories, and software classification rules.
"classification rules"
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