Seller Guardrails · EU MDR Annex VIII
Classify your medical device against MDR Annex VIII
Answer the device intake; watch Annex VIII rules 1–22 resolve on the right. Each applying rule cites its Annex excerpt and contributes to the highest class. The final seal carries the notified-body route + UK/CH equivalents.
MDR Annex VIII rule corpus verified 2026-06-16. Cross-check EUR-Lex + MDCG 2021-24 before filing your Declaration of Conformity.
Fill the device intake on the left; each Annex VIII rule will resolve here.
Provide device characteristics to compute the class.
- Risk classes
- 4 I · IIa · IIb · III (Annex VIII)
- Annex VIII rules
- 22 Rules 1–22; highest class governs
- Markets stamped
- 4 EU · EEA · UK · CH routes
How is a medical device classified under EU MDR Annex VIII?
The EU Medical Device Regulation (Regulation (EU) 2017/745, applying since 26 May 2021) assigns every device to Class I, IIa, IIb or III using the 22 rules in Annex VIII, based on duration of use, invasiveness, whether the device is active, and special characteristics. When more than one rule applies, the strictest rule giving the highest class governs. Class I devices (non-sterile, non-measuring, non-reusable-surgical) are self-declared; Class IIa, IIb and III require a notified body.
The deciding factors are duration of use (transient / short-term / long-term), invasiveness (non-invasive, body-orifice, surgically invasive, implantable), whether the device is active, and any special characteristics in Rules 14–22. Annex VIII §3.5 then takes the highest class any applying rule gives. → Walk your device through Rules 1–22 in the tool above to see which rules apply and the resulting class.
Legacy devices with a valid CE certificate benefit from the Reg (EU) 2023/607 transition: Class III devices and Class IIb implantable legacy devices may stay on the market until 31 December 2027 — except certain well-established Class IIb implantables (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), which instead have until 31 December 2028 — and other Class IIb, Class IIa and Class I sterile/measuring devices until 31 December 2028, subject to conditions. This tool walks Annex VIII rules 1–22 against your device intake and returns the class, the conformity-assessment route, and UK and Swiss equivalents — it is decision support, not legal advice, and MDR Art. 51 places classification responsibility on the manufacturer.
Sources: Regulation (EU) 2017/745 (MDR) Annex VIII — EUR-Lex (applies 26 May 2021) · MDCG 2021-24 Rev.1 — Guidance on classification of medical devices (European Commission) · Regulation (EU) 2023/607 Art. 120 — legacy-device transition (31 Dec 2027 / 31 Dec 2028)
MDR Annex VIII or IVDR Annex VIII — which one applies to you?
Two different EU regulations each have an "Annex VIII" holding classification rules, and they are not interchangeable. Check which one your product falls under before you classify it.
MDR — Regulation (EU) 2017/745, applying since 26 May 2021. Annex VIII holds 22 rules and four classes: I, IIa, IIb, III. It covers medical devices and their accessories — devices acting on or in the human body. This is the annex the tool on this page walks.
IVDR — Regulation (EU) 2017/746, applying since 26 May 2022. Its Annex VIII holds 7 rules and four classes: A, B, C, D. It covers in vitro diagnostic medical devices — reagents, instruments and kits that examine specimens taken from the body (blood, tissue, urine), including self-tests and companion diagnostics.
If your product tests a specimen outside the body, this tool does not apply: classify it under IVDR Annex VIII rules 1–7 instead. The Commission's guidance for that annex is MDCG 2020-16. Software can fall under either regulation depending on what it acts on, so confirm the qualification first.
Sources: Regulation (EU) 2017/745 (MDR) — EUR-Lex · Regulation (EU) 2017/746 (IVDR) — EUR-Lex
EU MDR Annex VIII classification rules 1–22, and the class each one gives
The full Annex VIII rule set, in the order the regulation states it and grouped the way it is applied: non-invasive devices first, then invasive, then active, then the special rules. Where several rules apply to one device, the strictest rule giving the highest class governs (Annex VIII Chapter III §3.5).
Rules 1–4 — Non-invasive devices
| Rule | What the rule covers (Annex VIII text) | Resulting class |
|---|---|---|
| 1 | Non-invasive devices — generalAll non-invasive devices are Class I, unless one of the rules set out hereinafter applies. | Class I. |
| 2 | Channelling or storing for administrationNon-invasive devices intended for channelling or storing blood, body liquids, cells or tissues for administration into the body. | Class I — Class IIa if the device may be connected to a class IIa, IIb or III active device, or if it channels or stores blood, other body liquids, organs, parts of organs, or body cells and tissues. Blood bags are Class IIb. |
| 3 | Modifying biological/chemical compositionNon-invasive devices intended for modifying the biological or chemical composition of blood, body liquids, cells or tissues. | Class IIb — Class IIa where the treatment consists of filtration, centrifugation or exchange of gas or heat. Class III for non-invasive devices consisting of a substance or mixture used in vitro in direct contact with human cells, tissues or organs. |
| 4 | Contact with injured skin or mucous membraneNon-invasive devices in contact with injured skin or mucous membrane — class depends on barrier/wound depth and microenvironment management. | Class I where the device is a mechanical barrier, for compression or for absorption of exudates — Class IIb for wounds which breach the dermis and can heal only by secondary intent; Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound. |
Rules 5–8 — Invasive devices
| Rule | What the rule covers (Annex VIII text) | Resulting class |
|---|---|---|
| 5 | Body orifice (non-surgical) invasiveInvasive devices with respect to body orifices, other than surgically invasive devices, that are not intended to connect to an active medical device. | Class I for transient use, Class IIa for short-term use, Class IIb for long-term use — one class lower in the oral cavity as far as the pharynx, in an ear canal up to the ear drum and in the nasal cavity (long-term only where the device is not liable to be absorbed by the mucous membrane). Class IIa if intended to connect to a class IIa or higher active device. |
| 6 | Surgically invasive — transient useAll surgically invasive devices intended for transient use (<60 minutes continuous). | Class IIa — Class I for reusable surgical instruments; Class IIb where the device supplies energy as ionising radiation, has a biological effect or is wholly or mainly absorbed, or administers medicinal products in a potentially hazardous manner; Class III for direct contact with the heart, the central circulatory system or the central nervous system, and for diagnosing, monitoring or correcting a defect of the heart or central circulatory system. |
| 7 | Surgically invasive — short-term useAll surgically invasive devices intended for short-term use (continuous use ≤ 30 days). | Class IIa — Class IIb where the device supplies energy as ionising radiation, undergoes a chemical change in the body (other than in the teeth) or administers medicinal products; Class III for direct contact with the heart, the central circulatory system or the central nervous system, and for devices with a biological effect or wholly or mainly absorbed. |
| 8 | Surgically invasive — long-term / implantableAll implantable devices and long-term surgically invasive devices. | Class IIb — Class IIa for devices placed in the teeth; Class III for active implantable devices and their accessories, direct contact with the heart, the central circulatory system or the central nervous system, a biological effect or being wholly or mainly absorbed, chemical change in the body (other than in the teeth), administration of medicinal products, breast implants, surgical meshes, and total or partial joint or spinal-disc replacements. |
Rules 9–13 — Active devices
| Rule | What the rule covers (Annex VIII text) | Resulting class |
|---|---|---|
| 9 | Active therapeutic — energy exchangeAll active therapeutic devices intended to administer or exchange energy. | Class IIa — Class IIb where energy is administered or exchanged in a potentially hazardous way, for devices controlling, monitoring or directly influencing class IIb therapeutic devices, and for devices emitting ionising radiation for therapy; Class III for devices controlling, monitoring or directly influencing active implantable devices. |
| 10 | Active for diagnosis or monitoringActive devices intended for diagnosis and monitoring — class depends on energy supplied, image of in vivo physiological processes, vital parameters. | Class IIa — Class I where the device only illuminates the patient's body in the visible spectrum; Class IIb for devices specifically intended to monitor vital physiological parameters where variations could result in immediate danger, and for devices emitting ionising radiation for diagnostic or interventional radiology. |
| 11 | Software (MDSW)Software intended to provide information used to take decisions with diagnosis or therapeutic purposes is Class IIa, unless decisions have an impact that may cause death or irreversible deterioration (Class III) or serious deterioration / surgical intervention (Class IIb). Software intended to monitor physiological processes is Class IIa, unless it monitors vital parameters where variations could result in immediate danger (Class IIb). All other software is Class I. | Class IIa for software providing information used for diagnostic or therapeutic decisions — Class IIb where those decisions may cause serious deterioration of health or a surgical intervention, and for software monitoring vital physiological parameters where variations could result in immediate danger; Class III where the decisions may cause death or an irreversible deterioration of health; Class I for all other software. |
| 12 | Active — administer or remove substancesAll active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body. | Class IIa — Class IIb where the administration or removal is done in a manner that is potentially hazardous, taking account of the substances, the body part and the mode of application. |
| 13 | All other active devicesAll other active devices are Class I. | Class I. |
Rules 14–22 — Special rules
| Rule | What the rule covers (Annex VIII text) | Resulting class |
|---|---|---|
| 14 | Devices incorporating a medicinal substanceAll devices incorporating, as an integral part, a substance which, if used separately, can be considered a medicinal product, are Class III. | Class III. |
| 15 | Contraception, STI preventionAll devices used for contraception or prevention of the transmission of sexually transmitted diseases are Class IIb (or Class III if implantable / long-term invasive). | Class IIb — Class III where the device is implantable or long-term invasive. |
| 16 | Disinfecting / sterilising medical devicesAll devices intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses are Class IIb. Devices for sterilising medical devices are Class IIa unless they sterilise invasive devices (Class IIb). | Class IIa for devices specifically intended for disinfecting or sterilising medical devices — Class IIb for disinfecting solutions or washer-disinfectors intended for disinfecting invasive devices as the end point of processing, and for devices for disinfecting, cleaning, rinsing or hydrating contact lenses. |
| 17 | Recording diagnostic imagesAll devices specifically intended for recording of diagnostic images generated by X-ray radiation are Class IIa. | Class IIa. |
| 18 | Devices using non-viable biological materialAll devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are Class III, except where used for contact with intact skin only. | Class III — outside this rule where the device is manufactured utilising non-viable tissues or cells of animal origin, or their derivatives, intended to come into contact with intact skin only. |
| 19 | Devices incorporating nanomaterialAll devices incorporating or consisting of nanomaterial are: Class III if they present a high or medium potential for internal exposure; Class IIb if they present a low potential for internal exposure; and Class IIa if they present a negligible potential for internal exposure. | Class III where the device presents a high or medium potential for internal exposure — Class IIb for a low potential, Class IIa for a negligible potential. |
| 20 | Invasive via orifice — inhalationAll invasive devices with respect to body orifices to administer medicinal products by inhalation are Class IIa, or Class IIb when in a manner which is potentially hazardous. | Class IIa — Class IIb where the mode of action has an essential impact on the efficacy and safety of the administered medicinal product, or where the device is intended to treat life-threatening conditions. |
| 21 | Substances introduced via body orifice / on skinDevices that are composed of substances or of combinations of substances introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body — Class III, IIb, or IIa depending on absorption profile. | Class III where the device or its metabolites are systemically absorbed, or where it achieves its intended purpose in the stomach or lower gastrointestinal tract and it or its metabolites are systemically absorbed — Class IIa where it is applied to the skin, or in the nasal or oral cavity as far as the pharynx, and achieves its purpose on those cavities; Class IIb in all other cases. |
| 22 | Active therapeutic with integrated diagnostic functionsActive therapeutic devices with an integrated or incorporated diagnostic function which significantly determines the patient management are Class III. | Class III. |
Rule 11 is the software rule: read it with MDCG 2019-11. Misjudging it is the most common SaMD compliance failure.
Not sure which of these apply to your device? Walk it through the classifier at the top of this page — it resolves all 22 rules and returns the governing class, the notified-body route and the UK and Swiss equivalents.
Rule text and class outcomes as published in Regulation (EU) 2017/745 Annex VIII; class outcomes cross-read against MDCG 2021-24 Rev.1. Rule corpus last verified 2026-06-16.
This tool is decision support, not legal advice. MDR Art. 51 places classification responsibility on the manufacturer. The Annex VIII rule corpus is refreshed quarterly; the dataset_pin date is the last verification against EUR-Lex + MDCG 2021-24. For Class IIa/IIb/III devices you must engage a notified body before placing the device on the EU market.
EU MDR classification — frequent questions
What are the device classes under EU MDR?
Regulation (EU) 2017/745 has four risk classes: Class I (low risk, e.g. most non-invasive devices), Class IIa (medium-low), Class IIb (medium-high) and Class III (high risk, e.g. active implantables and devices in contact with the heart or central nervous system). Class I devices that are supplied sterile, have a measuring function, or are reusable surgical instruments form a sub-group (often written I*) that needs notified-body involvement limited to those aspects. The class drives which conformity-assessment route under Annex IX, X or XI you must follow.
When does a medical device need a notified body?
Self-declaration (the manufacturer's own Declaration of Conformity) is only permitted for plain Class I devices. Class I sterile / measuring / reusable-surgical, and all Class IIa, IIb and III devices, require a notified body. The depth of assessment increases with class: Class III requires Annex IX Chapter II design-dossier examination on top of the quality-management-system audit. Engaging a notified body early matters because notified-body capacity under MDR is constrained.
How does Rule 11 classify medical device software (MDSW)?
Annex VIII Rule 11 (read with MDCG 2019-11) classifies standalone software by the significance of the information it provides. Software for diagnostic or therapeutic decisions is Class IIa; it rises to Class IIb if those decisions may cause serious deterioration of health or surgical intervention, and to Class III if they may cause death or an irreversible deterioration. Software that monitors vital physiological parameters where variations could create immediate danger is Class IIb. All other software is Class I. Misjudging Rule 11 is the most common SaMD compliance error.
Why is an active implantable device Class III and not Class IIb?
Rule 8 makes implantable and long-term surgically invasive devices Class IIb as a baseline, but it lists seven exceptions that escalate to Class III. Active implantable devices and their accessories are one of them — so a pacemaker, implantable defibrillator or neurostimulator is Class III, not IIb. The other Class III triggers under Rule 8 include direct contact with the heart, central circulatory system or central nervous system; a biological effect or being wholly or mainly absorbed; chemical change in the body; administering a medicinal product; and breast implants, surgical meshes, and joint or spinal-disc replacements.
What are the MDR transition deadlines for legacy devices?
Regulation (EU) 2023/607 extended the Art. 120 transition for devices that held a valid certificate or Declaration of Conformity under the old directives. Class III devices and Class IIb implantable legacy devices can remain on the market until 31 December 2027 — except certain well-established Class IIb implantables (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), which instead have until 31 December 2028; other Class IIb, Class IIa and Class I sterile/measuring devices until 31 December 2028. The extension is conditional — the manufacturer must, among other things, have a compliant quality-management system and have lodged an application with a notified body by the relevant cut-off. It does not change the device's classification, only the timeline to obtain an MDR certificate.
Does the EU classification apply in the UK and Switzerland?
Not automatically. Great Britain currently accepts CE-marked EU MDR devices until 30 June 2030 (MDD/AIMDD legacy devices until 30 June 2028), but the UKCA route uses the UK MDR 2002, which follows the old MDD classification rules and has no software Rule 11 — so a software class can diverge. Switzerland's EU–CH mutual recognition agreement lapsed, so a Swiss Authorised Representative (CH-REP) is required and Switzerland cannot be treated as EU-equivalent. This tool stamps UK and Swiss routes separately rather than copying the EU verdict blindly.
Is this classification legally binding?
No. MDR Art. 51 places the classification decision on the manufacturer, and where the manufacturer and notified body disagree the competent authority decides. This tool is a deterministic decision-support estimate that walks Annex VIII and cites MDCG 2021-24; it does not model every sub-clause of every rule and carries a last-verified date that pauses the verdict when the dataset goes stale. Cross-check the result against the live EUR-Lex text and MDCG 2021-24, and confirm borderline cases with your notified body before filing your Declaration of Conformity.