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Medical Device Classification under MDR & IVDR

Classification looks simple until your intended use meets Annex VIII. One wrong word can push your device into a higher class, new studies, and months of delay. Get it right and your pathway, budget, and audit story sharpen instantly. This guide helps RA, QA, clinical, manufacturing, and leadership teams make sound calls with confidence.

What is medical device classification under MDR & IVDR?

Medical device classification under the EU MDR and IVDR assigns products to risk-based classes that set the conformity assessment route, evidence burden, and notified body involvement. MDR uses Classes I, IIa, IIb, III for medical devices. IVDR uses Classes A, B, C, D for diagnostics. Higher classes demand stronger clinical or performance evidence and tighter oversight.

  • See how Medical Device Classification works in MDR and IVDR.
  • Learn who decides and when to lock the class.
  • Map EU classes to US 510(k), De Novo, PMA at a glance.
  • Grab the minimum documentation set auditors expect.
  • Use the checklist to classify your own product this week.
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First principles - what counts as a “medical device” or an “IVD”

Why this matters: 

  • Conformity assessment route and notified body involvement.

  • Depth of technical documentation and clinical or performance evidence.

  • Post-market surveillance and PMCF or performance follow-up needs.

  • Labeling claims, IFU scope, and change control impact.

    • Medical device - MDR: 

    any instrument, apparatus, implant, software, material, or other article intended for human use to diagnose, prevent, monitor, treat, or alleviate disease or injury, or to modify anatomy or a physiological process, or to control conception. Principal action is not pharmacologic, immunologic, or metabolic.

    Examples: stethoscopes, wound dressings, orthopedic implants, infusion pumps, surgical robots, software that calculates insulin doses.

    IVD - IVDR: reagents, instruments, software, and systems intended for in vitro examination of human specimens to provide information on physiological or pathological states, congenital anomalies, predisposition, or to monitor therapy.

    Examples: pregnancy tests, HbA1c kits, cancer biomarker panels, companion diagnostics, HIV donor screening, lab analyzers.

    When this matters: concept stage, before design lock - during technical documentation build - at each significant design or intended use change - at NB reviews.


    Who is responsible:     the manufacturer holds accountability - RA authors and defends the rationale - the Notified Body reviews and confirms.

    MDR Classes - What they cover, examples, and likely submissions

    Class I - Low Risk

    Typical: non-sterile, non-measuring, non-reusable surgical instruments.

    Examples:     manual wheelchairs, non-sterile dressings, stethoscopes, patient hoists.

    EU submission:     manufacturer self-declaration and CE marking. NB only if sterile, measuring, or reusable surgical instruments.

    US mapping:     often FDA Class I - many are 510(k)-exempt.
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    Class IIa - Medium Risk

    Risk drivers: short-term invasive use, active devices not sustaining life.

    Examples: dental filling materials, suction equipment, hearing aids, anesthesia masks, some software that informs but does not drive therapy.

    EU submission: technical documentation, QMS evidence, clinical evaluation - NB involvement required.

    US mapping: often FDA Class II with 510(k).
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    Class IIb - Higher Risk

    Risk drivers: longer-term invasive use, active devices administering medicines or energy.

    Examples: long-term contact lenses, ventilators, infusion pumps, spinal fixation systems, radiotherapy treatment planning software that directly influences therapy.

    EU submission: deeper clinical evaluation, NB design examination where applicable, PMS and PMCF plans.

    US mapping: typically FDA Class II with substantive 510(k) - some approach De Novo or PMA-like depth.
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    Class III - Highest Risk

    Risk drivers: life-supporting, life-sustaining, critical implants.

    Examples: pacemakers, implantable defibrillators, heart valves, total disc prostheses, absorbable drug-device combination implants.

    EU submission: robust clinical investigation, NB design dossier review, extensive PMCF.

    US mapping: FDA Class III with PMA - not 510(k).
    Write your awesome label here.

    IVDR Classes - what they cover, examples, and likely submissions

    Class A - Low Risk

    Examples: specimen receptacles, general lab instruments, some buffers.

    EU submission:     self-declaration unless sterile, then NB review.

    US mapping:     often Class I, usually exempt.

    Class B - Moderate Risk

    Examples: pregnancy tests, CRP assays, some fertility and thyroid tests.

    EU submission:     NB review of technical documentation, performance evaluation plan and report.

    US mapping:     often Class II with 510(k).

    Class C - High Risk

    Examples: blood glucose self-testing systems, oncology markers guiding treatment, companion diagnostics.

    EU submission:     performance studies, NB design dossier, PMS and performance follow-up.

    US mapping:     Class II or III depending on intended use - 510(k), De Novo, or PMA.

    Class D - Highest Risk

    Examples: HIV, HBV, HCV donor screening, emerging pathogen screening impacting public health.

    EU submission:     full NB involvement, EU reference laboratory verification where designated, stringent PMS.

    US mapping:     typically Class III with PMA.

    Minimum Documentation Set:
    What Auditors Expect to see

    • Intended use and indications - precise, measurable, and aligned to labeling.
    • Annex VIII rule mapping - MDR or IVDR rule-by-rule with the chosen class.
    • Qualification memo - why device or IVD is in scope and not a medicinal product.
    • Risk management summary - ISO 14971 linkage to hazards that drive class.
    • Clinical evaluation (MDR) or performance evaluation (IVDR) plan and summary.
    • Conformity assessment route - module selected, NB roles, certificates.
    • PMS and PMCF or performance follow-up plans - with triggers for updates.
    • Change control approach - how reclassification will be evaluated.

    Common gaps auditors flag - and fast fixes

    Empty space, drag to resize

    Vague intended use.

    Fix: write one sentence in plain language with user, purpose, specimen or tissue contact, and clinical context. Avoid “may help.”

    Rule misread.

    Fix: quote the exact Annex VIII text and show how each term matches your device.

    Labeling inconsistency.

    Fix: align claims, IFU, and website with the intended use used for class.

    Evidence mismatch

    Fix: show that clinical or performance evidence scales with class. Add a gap table with actions and timelines.

    Software impact understated.

    Fix: state if software drives diagnosis or therapy. If yes, expect higher class and stronger validation.

    Terms, Plain Meaning, Users, and Proof

    Term

    Plain meaning

    Who uses it

    Proof required

    Intended use

    What the product does, for whom, and in what context

    RA, clinical, marketing

    IFU, labeling, website copy

    Classification rule

    Legal rule that places your device in a class

    RA, NB

    Annex VIII mapping with citations

    Conformity assessment

    Route to show compliance and get CE mark

    RA, QA, NB

    Certificates, reports, audit records

    Clinical evaluation

    Evidence that benefits outweigh risks for MDR

    RA, clinical

    CEP, CER, literature, clinical data

    Performance evaluation

    Evidence that IVDR tests are accurate and reliable

    RA, lab, clinical

    PEP, PER, analytical and clinical performance

    PMS/PMCF

    Post-market plans to keep evidence current

    QA, RA

    PMS plan, PMCF plan, reports

    Notified Body

    EU-accredited conformity assessment organization

    RA, QA, leadership

    NB certificate, audit reports

    Process Overview

    A - Classification

    Trigger: New product or change to intended use
    Owner: RA lead
    Records: Qualification note, Annex VIII mapping
    Pitfalls: Underestimating impact of a single word in intended use

    B - Conformity assessment

    Trigger: Class confirmed and evidence plan set
    Owner: RA, QA, NB
    Records: Tech documentation, NB certs, test reports
    Pitfalls: Choosing the wrong module - late NB involvement

    C - Change control & reclass

    Trigger: Labeling or design change, new claim, new population
    Owner: RA with cross-functional RACI
    Records: Change assessment, updated mapping
    Pitfalls: Missing reclassification trigger and silent scope creep

    EU-to-US pathway snapshot & case study

    EU-to-US pathway mapping

    Use this as orientation only. Always verify current rules and guidance.
    • MDR I - self-declaration - often FDA Class I exempt.
    • MDR IIa/IIb - NB review - often FDA Class II 510(k); some De Novo for novel tech.
    • MDR III - NB design exam with clinical data - FDA PMA.
    • IVDR A - self-declaration unless sterile - often FDA Class I exempt.
    • IVDR B/C - NB review with performance evaluation - FDA 510(k) or De Novo depending on risk and novelty.
    • IVDR D - NB plus EU reference lab where applicable - FDA PMA.

    Mini case study - measurable outcomes

    • Before: A startup labeled its oncology algorithm as “advisory.” The tool prioritized chemotherapy regimens. NB considered it to directly influence therapy - Class IIb under MDR, not IIa. The team lacked clinical evaluation at that level. Result: 7-month delay and a 22 percent budget overrun.

    • After: The team rewrote intended use, added clinical evidence aligned to IIb, and ran a pre-assessment call with the NB. Approval followed in the next cycle. Time-to-CE improved by 4 months on the next product by reusing the mapping template and evidence framework.

    Step-by-step checklist

    • Draft one-line intended use that a clinician would sign off.
    • Confirm qualification - MDR device or IVDR IVD.
    • Walk Annex VIII line-by-line and pick the primary rule.
    • Document your class and the exact text that supports it.
    • Map EU class to likely US route - 510(k), De Novo, or PMA.
    • Size the evidence plan - clinical or performance - to class.
    • Select conformity assessment route and involve the NB early.
    • Align labeling and website to the intended use that drives class.
    • Write the PMS and PMCF or performance follow-up plans.
    • Store the package in technical documentation with a reclass trigger.

    FAQ's

    Who decides the class?

    The manufacturer proposes and documents it. The Notified Body reviews and confirms when involved.

    Can I choose a lower class to save cost?

    No. Class follows risk based on intended use, invasiveness, and impact.

    What if two rules seem to apply?

    Use the rule that leads to the higher class. Document why.

    How often should I revisit classification?

    At every intended use, labeling, or key design change - and when new guidance publishes.

    Are software devices covered by MDR?

    Yes. Software with a medical purpose is covered. If it drives diagnosis or therapy, expect higher class.

    How do IVDR performance claims scale with class?

    Classes C and D need strong analytical and clinical performance data. D may need EU reference lab verification.

    Is US 510(k) the same as EU IIa/IIb?

    Not exactly. Risk logic differs. Use the mapping to anticipate effort, then check current FDA guidance.

    Glossary

    • Annex VIII - section that contains classification rules.
    • CER - Clinical Evaluation Report under MDR.
    • De Novo - US pathway for novel moderate risk devices.
    • IFU - Instructions for Use.
    • NB - Notified Body.
    • PMA - Premarket Approval in the US for high risk devices.
    • PMS - Post-market Surveillance.
    • PMCF - Post-market Clinical Follow-up.
    • PEP/PER - Performance Evaluation Plan/Report under IVDR.
    • QMS - Quality Management System, often ISO 13485.
    • RACI - Responsibility matrix for processes.
    • Risk class - category that sets oversight intensity.
    • Technical documentation - full evidence package for CE.
    • Intended use - the precise medical purpose and context.
    • Conformity assessment - route to CE with or without NB.

    Final Word (If You’re Still Reading)

    Get Medical Device Classification right at concept stage and your downstream work becomes simpler - evidence plans fit, timelines stabilize, and audits read clean. Treat the intended use sentence as code. Map Annex VIII carefully. Engage your NB early. Update your class whenever claims or design move. That discipline protects launch dates and budgets.