Medical device classification helper
Work through the EU classification rules for a medical device and its software step by step, and see the class, the rule that applied and the conformity route.
Safety and securityFree to useHow it worksSourcesWhere it helps
Fills the inputs below with typical figures. Replace any of them with your own.
- EU class
- Class I
- Set by rule 1: Non-invasive devices
- Rules that applied
- 1
- One rule applied
- FDA class (indicative)
- Class I
- Separate from the EU class
- IEC 62304 software safety class
- Not applicable
- The device has no software that is part of it, so the software standard does not apply.
| Rule | Class | What it covers | Why it applied |
|---|---|---|---|
| 1 | I | Non-invasive devices | All non-invasive devices are class I unless a rule below applies. |
Longer bar, higher class (I shortest, III longest). The strictest rule decides.
- Rule 1: Non-invasive devicesClass I
Show the data as a table
| Item | Class |
|---|---|
| Rule 1: Non-invasive devices | Class I |
Class I: the manufacturer declares conformity
- The manufacturer draws up the technical documentation and a declaration of conformity and affixes the CE mark, with no notified body.
- A notified body is not needed unless the device is sterile, has a measuring function or is a reusable surgical instrument.
- The quality management system, post-market surveillance, registration and vigilance duties of a manufacturer still apply.
- This is a brief outline of Article 52 and Annexes IX to XI. The notified body and the regulation decide the exact route.
FDA classification
Indicative: Class I (lowest risk). Many Class I device types are exempt from premarket notification, but this depends on the device type. FDA assigns the class to a device type, found by its product code and regulation number in 21 CFR; it does not derive it from rules like these. A novel device with no match may need a De Novo request.
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| Example | EU class | Rule that set it | FDA (indicative) | IEC 62304 class |
|---|---|---|---|---|
| Wearable heart-rate monitor app (medical purpose) | Class IIa | 11 | Class II | Class B |
| Diagnostic imaging software that supports a diagnosis | Class IIb | 11 | Class II | Class C |
| Insulin pump controller, the user confirms every dose | Class IIb | 12 | Class II | Class C |
| Insulin pump controller, closed loop with automatic dosing | Class III | 22 | Class III | Class C |
| Reusable surgical instrument (forceps, scalpel handle) | Class I | 6 | Class I | |
| Electrosurgical generator | Class IIb | 9 | Class II | Class C |
| Total hip joint replacement | Class III | 8 | Class III | |
| Gauze wound dressing | Class I | 4 | Class I | |
| Wellness app that counts steps and resting heart rate | Not a device |
How it works
In the EU, a medical device is sorted into class I, IIa, IIb or III by the 22 rules of Annex VIII of the Medical Device Regulation, and the class sets how much a notified body must check before the CE mark. This helper asks plain questions about the product, applies the rules that fit, and shows every rule that applied, the strictest one, the conformity route in brief, and, as separate results, an indicative FDA class and the IEC 62304 software safety class.
- Check the product is a medical device. The rules only apply to a product with a medical purpose set by the manufacturer: diagnosing, preventing, monitoring, predicting, treating or relieving disease or injury, or investigating or supporting the body's structure or processes. A wellness app that counts steps is outside the Regulation until it claims a medical purpose.
- Describe what the product is and how it touches the body. Standalone software is classified by rule 11. Software that drives or influences a physical device takes the class of the device. A physical device is placed by how it touches the body: not at all or intact skin (rules 1 to 3), injured skin (rule 4), a body opening (rule 5), through the surface or a cut (rules 6 and 7) or as an implant or in long-term use (rule 8), and by how long it is used: transient is under 60 minutes, short term is up to 30 days and long term is more than 30 days.
- Add energy, active devices and software. An active device depends on an energy source other than the body or gravity. Rules 9 and 12 cover active devices that treat or give substances (class IIa, or IIb if potentially hazardous); rule 10 covers diagnosis and monitoring; rule 13 catches other active devices as class I; rule 22 makes a treatment device with a built-in diagnostic function that decides the treatment class III. Rule 11 sorts software by the worst decision its information could lead to.
rule 11: informs decisions = IIa, or IIb if serious deterioration or surgery is possible, or III if death or irreversible harm is possible; monitors = IIa, or IIb for vital parameters with immediate danger; other software = I - Check the special rules. Rules 14 to 21 pick out products with a medicine, contraceptives, disinfecting products, X-ray image recording, tissues of human or animal origin, nanomaterial, inhaled medicines and substances absorbed by the body. Each one that fits is listed.
- Take the strictest rule. When more than one rule applies to the same product, the highest class wins. The result lists every rule that applied and names the rule or rules that set the class.
class = highest class among the rules that apply; ranks I = 1, IIa = 2, IIb = 3, III = 4 - Read the route and the other two classes. The conformity route is a brief outline for the class. The FDA result is indicative only: FDA assigns Class I, II or III to a device type found in its classification database, not by rules. The IEC 62304 software safety class is a different question: it follows the worst harm a software failure could still contribute to, with A for no injury, B for injury that is not serious and C for death or serious injury.
Assumptions
- The questions are the Hub's own plain wording of the rules, shortened. The rule number is shown on each question so you can read the Regulation text.
- The intended purpose the manufacturer states decides the class, not what the product could do. Change the purpose and the class can change.
- Accessories are classified in their own right, apart from the device they are used with.
- The FDA result is an indicative mapping from the EU class and is not a determination. The FDA class comes from the device type.
- The IEC 62304 class follows the harm you choose, after risk controls outside the software. It is not derived from the EU class.
Limits and warnings
- A classification aid, not regulatory advice. A notified body or a regulator decides the class, and a competent authority settles a dispute between a manufacturer and a notified body.
- Some sub-cases of the rules are shortened or left out, for example invasive devices that touch injured skin, ancillary components of joint replacements and the fine points of rules 2, 8 and 16. Read the full rule and the guidance before relying on a result.
- In vitro diagnostic devices are classified under a different Regulation (EU) 2017/746, not by these rules.
- The guidance on classification was revised in 2026 and changed the explanations of several rules. The Regulation text is the authority; check the current guidance.
- Combinations of several devices, kits and systems, and devices whose intended purposes differ, need a rule-by-rule assessment of each part.
Sources
The methods and default figures rest on these public sources. The wording here is our own; read the source for its full text.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Annex VIII (classification rules) and Article 52 (conformity assessment) (opens in a new tab), European Union, Official Journal of the European Union (EUR-Lex), 5 April 2017, consolidated text. Public law. The rule wording was read through the guidance below, because the EUR-Lex page could not be opened by a script.
- MDCG 2021-24, Guidance on classification of medical devices (opens in a new tab), Medical Device Coordination Group (European Commission), October 2021; revision 1, April 2026. Explains each rule with examples. Not legally binding.
- MDCG 2019-11, Guidance on qualification and classification of software in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (opens in a new tab), Medical Device Coordination Group (European Commission), October 2019; revision 1, June 2025. When software is a medical device and how rule 11 and implementing rule 3.3 apply. Not legally binding.
- Classify Your Medical Device (opens in a new tab), U.S. Food and Drug Administration, content current as of 26 August 2026. Class I, II and III, premarket notification and approval, and how to find a device's classification by product code.
- IEC 62304:2006+AMD1:2015, Medical device software, Software life cycle processes, International Electrotechnical Commission, 2006, amended 2015. Software safety classes A, B and C (clause 4.3); cited by name and clause only.
Where it helps
The lifecycle stages this tool serves: 1 stage in 1 lifecycle.
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Method notev1Formula, ranges, sources and limits
Applies the classification rules of Annex VIII of Regulation (EU) 2017/745 to a set of plain answers and returns the class, the rules that applied, an indicative FDA class and the IEC 62304 software safety class.
Formula
rule 11: informs decisions = IIa, or IIb if serious deterioration or surgery is possible, or III if death or irreversible harm is possible; monitors = IIa, or IIb for vital parameters with immediate danger; other software = I; class = highest class among the rules that apply; ranks I = 1, IIa = 2, IIb = 3, III = 4
| Input | Unit | Range it holds for | Comes from |
|---|---|---|---|
| Is it intended for a medical purpose, such as diagnosing, preventin... | choice | yes, no | Your figure |
| What is it? | choice | software, device | Your figure |
| What does the software do for the clinical user? | choice | decisions, monitoring, other | Your figure |
| If the information were wrong or late, what is the worst decision i... | choice | minor, serious, critical | Your figure |
| Does it monitor vital physiological parameters whose variations cou... | choice | no, yes | Your figure |
| How does it touch the body? | choice | none, intact-skin, injured, orifice, surgical, implant | Your figure |
| How long is it meant to stay in continuous use? | choice | transient, short, long | Your figure |
| Does it channel or store blood, body liquids, cells, tissues, liqui... | choice | no, active-connect, fluids, blood-bag | Your figure |
| Does it change the biological or chemical make-up of blood, body li... | choice | no, filtration, other | Your figure |
| What is it meant to do on the injured skin or membrane? | choice | barrier, secondary-intent, other | Your figure |
| Where in the body opening does it work? | choice | oral-ear-nasal, other | Your figure |
| Is it meant to be connected to an active device of class IIa or hig... | choice | no, yes | Your figure |
| Is it wholly or mainly absorbed by the body, or does it have a biol... | choice | no, yes | Your figure |
| Is it a reusable surgical instrument? | choice | no, yes | Your figure |
| Is it meant for direct contact with the heart, the central circulat... | choice | no, yes | Your figure |
| Does it undergo a chemical change in the body? | choice | no, yes | Your figure |
| Is it placed in the teeth? | choice | no, yes | Your figure |
| Does it deliver medicinal products through a delivery system? | choice | no, yes | Your figure |
| Does it supply energy as ionising radiation? | choice | no, yes | Your figure |
| Is it one of these implants? | choice | none, active, mesh-breast, joint, spinal | Your figure |
| Does it depend on a source of energy other than the body or gravity... | choice | no, therapeutic, diagnostic, substances, other | Your figure |
| Could the energy, medicine or other substance be given in a potenti... | choice | no, yes | Your figure |
| Does it control or monitor, or directly influence, an active therap... | choice | no, yes | Your figure |
| Does it control, monitor or directly influence an active implantabl... | choice | no, yes | Your figure |
| What kind of diagnosis or monitoring is it? | choice | none, energy, illumination, radiopharm, vital-direct, vital-danger, ionising | Your figure |
| Does it have a built-in diagnostic function that decides the patien... | choice | no, yes | Your figure |
| Does it include, as an integral part, a substance that would be a m... | choice | no, yes | Your figure |
| Is it used for contraception or to prevent sexually transmitted dis... | choice | no, yes | Your figure |
| Is it meant for disinfecting, cleaning, rinsing or sterilising? | choice | no, lens, device, invasive-end | Your figure |
| Is it meant to record diagnostic images made with X-rays? | choice | no, yes | Your figure |
| Is it made with non-viable human or animal tissues, cells or their... | choice | no, yes, intact-skin-only | Your figure |
| Does it contain or consist of nanomaterial, and how likely is inter... | choice | no, negligible, low, medium-high | Your figure |
| Does it enter a body opening to give a medicine by inhalation? | choice | no, yes, essential | Your figure |
| Is it made of substances put in through a body opening or on the sk... | choice | no, systemic, gi-systemic, skin-nasal-oral, other | Your figure |
| Is it supplied sterile? | choice | no, yes | Your figure |
| Does it have a measuring function? | choice | no, yes | Your figure |
| Does the device contain software that is part of it? | choice | no, yes | Your figure |
| After the risk controls outside the software, what is the worst har... | choice | none, nonserious, serious | Your figure |
Outputs: EU class (1 = I, 2 = IIa, 3 = IIb, 4 = III, 0 = not a device) (rank); Rules that applied (count); Rule that set the class (rule number); Indicative FDA class (1 = I, 2 = II, 3 = III) (rank); IEC 62304 software safety class (1 = A, 2 = B, 3 = C, 0 = none) (rank).
Assumptions
- The questions are the Hub's own plain wording of the rules, shortened. The rule number is shown on each question so you can read the Regulation text.
- The intended purpose the manufacturer states decides the class, not what the product could do. Change the purpose and the class can change.
- Accessories are classified in their own right, apart from the device they are used with.
- The FDA result is an indicative mapping from the EU class and is not a determination. The FDA class comes from the device type.
- The IEC 62304 class follows the harm you choose, after risk controls outside the software. It is not derived from the EU class.
Uncertainty: The logic is exact for the rules it implements. The class depends on the answers, which are judgements about the intended purpose, and a notified body can reach a different class.
Known limits
- A classification aid, not regulatory advice. A notified body or a regulator decides the class, and a competent authority settles a dispute between a manufacturer and a notified body.
- Some sub-cases of the rules are shortened or left out, for example invasive devices that touch injured skin, ancillary components of joint replacements and the fine points of rules 2, 8 and 16. Read the full rule and the guidance before relying on a result.
- In vitro diagnostic devices are classified under a different Regulation (EU) 2017/746, not by these rules.
- The guidance on classification was revised in 2026 and changed the explanations of several rules. The Regulation text is the authority; check the current guidance.
- Combinations of several devices, kits and systems, and devices whose intended purposes differ, need a rule-by-rule assessment of each part.
Where the method comes from
Follows Regulation (EU) 2017/745, Annex VIII: classification rules (EUR-Lex) (opens in a new tab). The platform's version departs from it as follows.
- The rules are asked as a short list of choices instead of read in full Why: A guided flow lets a non-specialist reach the rule without reading all 22 rules, at the cost of leaving out some sub-cases.
- An indicative FDA class and the IEC 62304 software class are added Why: Teams selling in more than one market ask for them together; they are separate outputs and do not change the EU class.
Reference example, checked by test: Worked by hand from Annex VIII: an active device that delivers a substance in a potentially hazardous way is class IIb under rule 12; as a non-invasive device it also meets rule 1 (class I), so two rules apply and rule 12 sets the class. With software whose failure could contribute to serious injury, IEC 62304 class C; the indicative FDA class is II. EU class (1 = I, 2 = IIa, 3 = IIb, 4 = III, 0 = not a device) 3; Rules that applied 2; Rule that set the class 12; Indicative FDA class (1 = I, 2 = II, 3 = III) 2; IEC 62304 software safety class (1 = A, 2 = B, 3 = C, 0 = none) 3.
Versions
- v1 (2026-10-25): First version, built from the tool idea.
Terms on this page
- MDR
- The EU Medical Device Regulation, Regulation (EU) 2017/745, which sets the requirements for placing medical devices on the EU market, including clinical evidence, risk management, technical documen...
- CE marking
- The mark a maker places on a product to declare that it meets the EU laws that apply to it, such as those on electromagnetic compatibility, radio equipment, low voltage safety and hazardous substan...
- FDA
- The US Food and Drug Administration, which regulates medical devices sold in the United States, including the electronics and software inside them.
- IEC 62304
- The standard governing medical device software, classifying it as safety class A, B or C by the severity of harm a failure could cause and setting required life-cycle activities for each.
- Ion implantation
- Introducing dopants by accelerating ionised atoms into the wafer, with dose and energy setting concentration and depth.
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