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WorkflowEU

EU MDR qualification workflow

Review this workflow before MDR classification. It turns , 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
Jul 24, 2026
4 sections4 primary sources
Overview

EU MDR qualification starts with the manufacturer's and the product evidence around it. Decide whether the product is a medical device, an , a covered 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 . 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 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.
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, although those means may assist its function. Test status separately. For an without a medical purpose, Article 1(2) applies the MDR from the application date of the relevant common specifications rather than from the medical-device definition.

Annex XVI covers six product groups: non-corrective contact lenses and similar eye items; surgically invasive products used to modify anatomy or fix body parts without a medical purpose; dermal or mucous-membrane fillers other than tattoo products; equipment used to reduce, remove, or destroy adipose tissue; high-intensity electromagnetic-radiation equipment for skin treatment; and transcranial brain-stimulation equipment. Commission Implementing Regulation (EU) 2022/2346 supplies the common specifications and narrower inclusions or exclusions. For example, it excludes sunbeds and infrared equipment intended only to warm the body from its skin-treatment specifications. Record the exact product-group and common-specification match rather than treating every aesthetic product as an .

  • Device test: map the 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.
  • 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 or directly assist their medical functionality.
  • Annex XVI test: identify the listed product group and the application date of its common specifications. Flag dual-purpose products because Article 1 requires them to meet cumulatively the requirements for the medical and non-medical intended purposes.
  • 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.
  • Authority route: MDR Article 4 allows the Commission, after consulting the MDCG, to determine by implementing act whether a specific product or product category meets the medical-device or definition. Until an applicable determination resolves the point, preserve the case-specific evidence and use the relevant competent-authority or legal route rather than treating an internal rationale as an official status decision.
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 administers a medicinal product, record whether it is a device governed by the MDR or a single integral product governed by the medicinal-product framework. For the latter route, the device part must meet the applicable Annex I GSPRs and, where Article 117 applies, the marketing-authorisation dossier must include the available conformity-assessment results or, when those results are absent and separate-device assessment would require a notified body, a notified-body opinion.
  • 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 product facts and controlling sources support that handoff.
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 , MDR , 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 , 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.
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Primary sources

References and citations

Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu5 citations
Referenced sections
  • Primary MDR source for device and accessory definitions, intended purpose, Annex XVI scope, exclusions, borderline determinations, classification handoff, and conformity-assessment structure.
  • Defines intended purpose by reference to the manufacturer's label, instructions for use, promotional or sales materials or statements, and clinical evaluation.
  • Provides the medical-device definition, accessory definition, Annex XVI scope rule, dual-purpose rule, exclusions, and Commission borderline-determination mechanism.
Show 2 more
  • Grounds MDR exclusions and interfaces for IVDR products, medicinal products, integral IVD parts, medicinal substances with ancillary action, and medicinal-product administration devices.
  • Grounds the handoff from qualification to Annex VIII classification, including intended-purpose-based rules, separate classification of accessories, and software classification rules.
"placing on the market"
More quoted passages
"intended purpose"
"medical device"
"principal mode of action"
"classification rules"
Commission Implementing Regulation (EU) 2022/2346 on Annex XVI common specifications
eur-lex.europa.eu2 citations
Referenced sections
  • Binding source for common specifications, product-group boundaries, examples, and exclusions for products without an intended medical purpose listed in MDR Annex XVI.
  • Defines the common specifications and product boundaries used for the six Annex XVI groups, including the skin-treatment equipment exclusions.
European Commission - notified bodies for medical devices
health.ec.europa.eu2 citations
Referenced sections
  • Commission source for notified-body context after qualification and classification identify a conformity-assessment route requiring notified-body involvement.
  • Commission source for the notified-body context used when a qualified and classified MDR product needs conformity-assessment route planning.
"notified bodies"
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
eur-lex.europa.eu2 citations
Referenced sections
  • Source for the IVDR interface when product or software qualification depends on in vitro diagnostic information.
  • Source for the IVDR interface where software or a product is driven by in vitro diagnostic information rather than MDR device information.
"in vitro diagnostic"

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