EU MDR Classification Wizard

Answer the following questions to determine the classification of your medical device. This wizard covers all 22 classification rules including special rules for nanomaterials, medicinal substances, and biological materials.

Device name (optional, for your records):

Step 1: Device Category

What type of medical device are you classifying?

Non-invasive device Does not penetrate the body (e.g., bandages, wheelchairs, diagnostic equipment) Invasive device Penetrates the body via orifice or surgically (e.g., catheters, implants, surgical tools) Active device Operates using electrical energy or power source (e.g., monitors, pumps, imaging equipment) Software / SaMD Software as a Medical Device or software controlling medical devices

Step 2: Non-invasive Device Details (Rules 1-4)

What is the primary function of the device?

General support/containmentSimple containment, support, or external immobilization (e.g., hospital beds, wheelchairs, crutches) Channeling or storing substancesChannels, stores, or connects to devices for administration (e.g., tubing, syringes without needles) Modifies biological/chemical compositionFiltration, centrifugation, gas exchange (e.g., dialysis equipment, blood filters) Contact with injured skin/woundsWound dressings, burn treatments, skin contact devices

Is the device connected to an active device of Class IIa or higher?

Yes, connected to Class IIa or higher active device No, or connected to Class I device only

Is the device used for storing or channeling blood or blood products for transfusion/infusion?

Yes No

What type of modification does the device perform?

Haemodialysis, haemofiltration, or haemodiafiltration Filtration, centrifugation, or gas/heat exchange for blood Other modification of biological composition

What is the severity of the wound/skin condition being treated?

Minor wounds (superficial cuts, abrasions) Moderate wounds requiring active management Severe wounds (burns, deep dermis breaches requiring secondary healing)

Does the device actively manage the wound healing environment?

Yes - actively manages wound environment (e.g., negative pressure, moisture control) No - provides mechanical barrier only

Step 2: Invasive Device Details (Rules 5-8, 20)

How does the device enter/contact the body?

Via natural body orificeEnters through mouth, nose, ear, eye, urethra, vagina, rectum Surgically invasivePenetrates body surface via surgical intervention or incision Implantable deviceTotally or partially introduced into the body and remains after procedure

What is the intended duration of use?

TransientLess than 60 minutes continuous use Short-termBetween 60 minutes and 30 days Long-termMore than 30 days continuous use

Which body location does the device contact or act upon?

Oral cavity (to pharynx), ear canal (to tympanum), or nasal cavity Heart or direct contact with heart Central circulatory system (arteries, major veins) Central nervous system (brain, spinal cord) Other body location

Does the device contact or act upon any of these specific locations?

Heart or direct contact with heart Central circulatory system Central nervous system None of the above

Is the invasive device connected to an active medical device?

Yes No

What is the class of the active device it connects to?

Class IIb or Class III Class IIa or lower

Is this a reusable surgical instrument?

Yes - intended to be reprocessed and reused No - single use

Does the device deliver or exchange energy?

Yes - delivers potentially hazardous energy (ionizing, thermal, electrical) Yes - but not potentially hazardous No

Does the device have a biological effect or is wholly/mainly absorbed?

Yes - biological effect or absorbed No

Is this device any of the following? (Select if applicable)

Joint replacement (total or partial) Spinal disc replacement or contacts spinal column Breast implant None of the above

Step 2: Active Device Details (Rules 9-12)

What is the primary function of the active device?

TherapeuticDelivers/exchanges energy for treatment (e.g., defibrillators, surgical lasers, TENS units) DiagnosticSupplies energy for viewing, monitoring, or examining (e.g., MRI, ultrasound, ECG) Administers or removes substancesInfusion pumps, suction devices, nebulizers

What type of energy does the device deliver?

Ionizing radiation Other energy type (electrical, thermal, mechanical, light)

What is the nature/level of energy delivery?

Potentially hazardous (can cause tissue damage, burns) Generally safe energy levels

What is the diagnostic purpose?

Emits ionizing radiation (X-ray, CT) Monitors vital parameters where variations could result in immediate danger Monitors vital physiological parameters (general monitoring) Provides illumination in visible spectrum (examination lights) Other diagnostic function

Does the device record X-ray diagnostic images?

Yes No

Is the device life-supporting or life-sustaining?

Yes (e.g., ventilators, heart-lung machines) No

Does the device control or monitor parameters where variations could result in immediate danger to patient?

Yes - failure could cause immediate danger No

Are the substances administered/removed potentially hazardous?

Yes - potentially hazardous (medicines, blood) No - not hazardous (fluids, general substances)

Step 2: Software Details (Rule 11)

What is the primary function of the software?

Drives or influences a deviceControls or affects the use of another medical device Clinical decision supportProvides information for diagnosis, treatment, or prevention decisions MonitoringMonitors physiological parameters or patient data General medical softwareOther medical software functions (data management, scheduling)

What is the class of the device it drives or influences?

Class III device Class IIb device Class IIa device Class I device

What could be the impact of incorrect information from the software?

Could cause death or irreversible deterioration of health Could cause serious deterioration of health or surgical intervention Could affect other health conditions not mentioned above Minimal health impact

Does the software monitor vital physiological parameters?

Yes - where variations could result in immediate danger Yes - vital parameters but not immediate danger No - does not monitor vital parameters

Step 3: Special Characteristics (Rules 13-22)

These questions determine if any special classification rules apply to your device.

Does the device incorporate a medicinal substance? Rule 13

Yes - contains a medicinal substance (e.g., drug-eluting stent, antibiotic bone cement) No

What is the role of the medicinal substance?

Ancillary action to the device function Primary mechanism of action (may not be a device)

Is the device used for contraception or prevention of STIs? Rule 14

Yes No

What type of contraceptive/STI prevention device?

Implantable contraceptive Long-term invasive (e.g., IUD) Other (e.g., condoms, diaphragms)

Is the device specifically intended to disinfect or sterilize medical devices? Rule 15

Yes No

What does the device disinfect/sterilize?

Medical devices Invasive medical devices Contact lenses Non-invasive devices only

Does the device incorporate tissues or cells of human or animal origin? Rule 17

Yes No

What type of biological material?

Non-viable human tissues or cells Non-viable animal tissues or cells Derivatives (rendered non-viable)

Is this a blood bag? Rule 18

Yes No

Does the device contain or consist of nanomaterials? Rule 19

Yes No

What is the potential for internal exposure to the nanomaterials?

High potential (free release intended, systemic distribution) Medium potential (contained but possible release) Low potential (encapsulated, no expected release)

Does the device consist of substances to be ingested, inhaled, or administered to the body? Rule 21

Yes No

What is the route of administration?

Oral (swallowed) Inhaled Rectal Vaginal

Is the substance absorbed systemically?

Yes - absorbed by the body / systemic effect No - local action only

Is this an active therapeutic device with an integrated diagnostic function that significantly determines patient management? Rule 22

Yes (e.g., closed-loop insulin pump with continuous glucose monitoring) No

Step 4: Additional Characteristics

Does the device have a measuring function?

Yes - provides measurements for diagnosis or treatment No

Is the device supplied sterile?

Yes No

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About EU MDR Classification

The EU Medical Device Regulation (MDR 2017/745) classifies devices based on 22 rules in Annex VIII, considering:

Duration of use - Transient (<60 min), Short-term (<30 days), Long-term (>30 days)
Invasiveness - Body orifice, surgically invasive, implantable
Active device - Uses energy source for operation
Special materials - Nanomaterials, biological tissues, medicinal substances
Body location - Heart, CNS, central circulation

Note: This wizard provides guidance based on simplified MDR rules. Final classification should be verified with a Notified Body.

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Step 1: Device Category

Step 2: Non-invasive Device Details (Rules 1-4)

Step 2: Invasive Device Details (Rules 5-8, 20)

Step 2: Active Device Details (Rules 9-12)

Step 2: Software Details (Rule 11)

Step 3: Special Characteristics (Rules 13-22)

Step 4: Additional Characteristics

About EU MDR Classification

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