# EU MDR Annex VIII Classification Rules Reference (Rules 1 to 22)

> Source: https://netray.co/tools/eu-mdr-annex-viii-classification-rules-reference
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

A searchable summary of the 22 classification rules in Annex VIII of Regulation (EU) 2017/745 with the class each rule typically leads to.

## Category

compliance-legal

## Industry

Medical Devices

## Region

European Union

## Audience

- Regulatory affairs
- Quality engineer

## Tool

**Kind:** worksheet

**Mode:** reference

**Columns:**

#### Rule

**Key:** rule

**Type:** text

#### Topic

**Key:** topic

**Type:** text

#### Group

**Key:** group

**Type:** text

#### Class outcome (summary)

**Key:** default_class

**Type:** text

**Rows:**

#### Non-invasive devices that touch only intact skin or do not touch the patient

**Rule:** Rule 1

**Group:** Non-invasive

**Default class:** Class I

#### Non-invasive devices intended for channelling or storing body liquids, tissues, gases for later administration

**Rule:** Rule 2

**Group:** Non-invasive

**Default class:** Class IIa, with IIb where connected to higher class active devices or used for certain blood storage

#### Non-invasive devices that modify the biological or chemical composition of blood, body liquids or other liquids for infusion

**Rule:** Rule 3

**Group:** Non-invasive

**Default class:** Class IIb, with IIa in limited filtration cases

#### Non-invasive devices that contact injured skin or mucous membrane

**Rule:** Rule 4

**Group:** Non-invasive

**Default class:** Class I, IIa or IIb depending on the wound type and purpose

#### Invasive devices in body orifices, not surgically invasive

**Rule:** Rule 5

**Group:** Invasive

**Default class:** Class I, IIa or IIb depending on duration and location

#### Surgically invasive devices for transient use

**Rule:** Rule 6

**Group:** Invasive

**Default class:** Class IIa by default, with IIb or III for specific uses such as heart or central circulation contact

#### Surgically invasive devices for short-term use

**Rule:** Rule 7

**Group:** Invasive

**Default class:** Class IIa by default, with IIb or III for specific uses

#### Implantable devices and long-term surgically invasive devices

**Rule:** Rule 8

**Group:** Invasive

**Default class:** Class IIb by default, with IIa and III for specified cases

#### Active therapeutic devices intended to administer or exchange energy

**Rule:** Rule 9

**Group:** Active

**Default class:** Class IIa by default, with IIb where the energy delivery is potentially hazardous

#### Active devices intended for diagnosis and monitoring

**Rule:** Rule 10

**Group:** Active

**Default class:** Class IIa by default, with IIb for vital physiological parameter monitoring in some cases

#### Software intended to provide information used for diagnostic or therapeutic decisions, or to monitor physiological processes

**Rule:** Rule 11

**Group:** Software

**Default class:** Class IIa by default, with IIb or III depending on potential harm; other software Class I

#### Active devices intended to administer or remove medicinal products, body liquids or other substances

**Rule:** Rule 12

**Group:** Active

**Default class:** Class IIa, with IIb where the manner is potentially hazardous

#### All other active devices

**Rule:** Rule 13

**Group:** Active

**Default class:** Class I

#### Devices incorporating a medicinal substance as an integral part

**Rule:** Rule 14

**Group:** Special

**Default class:** Class III

#### Devices used for contraception or prevention of sexually transmitted diseases

**Rule:** Rule 15

**Group:** Special

**Default class:** Class IIb, with III for implantable or long-term invasive ones

#### Devices intended for disinfecting, cleaning, rinsing or hydrating contact lenses

**Rule:** Rule 16

**Group:** Special

**Default class:** Class IIb

#### Devices specifically intended for disinfecting or sterilizing medical devices

**Rule:** Rule 17

**Group:** Special

**Default class:** Class IIa, with IIb for those used on invasive devices as the end point of processing

#### Devices manufactured using non-viable animal or human tissues or cells

**Rule:** Rule 18

**Group:** Special

**Default class:** Class III, with exceptions for devices contacting only intact skin

#### Devices incorporating or consisting of nanomaterial

**Rule:** Rule 19

**Group:** Special

**Default class:** Class III, IIb or IIa depending on the potential for internal exposure

#### Invasive devices in body orifices intended to administer medicinal products by inhalation

**Rule:** Rule 20

**Group:** Special

**Default class:** Class IIa, with IIb where efficacy or safety is critical

#### Devices composed of substances introduced into the body or absorbed by it

**Rule:** Rule 21

**Group:** Special

**Default class:** Class III, IIb or IIa depending on route and action

#### Active therapeutic devices with an integrated or incorporated diagnostic function that significantly determines patient management (closed loop)

**Rule:** Rule 22

**Group:** Special

**Default class:** Class III

**Notes:** This is a simplified summary for orientation. The rule text in Annex VIII and the MDCG classification guidance contain conditions and exceptions that change the outcome. Apply the implementing rules in Chapter II of Annex VIII, and when several rules apply, the highest class applies. Confirm the final class with your notified body or regulatory specialist.

## Content

**Intro:** Under Regulation (EU) 2017/745 the device class decides the conformity assessment route, notified body involvement and the depth of clinical evidence. This reference condenses the 22 Annex VIII rules into a table you can search by topic.

**Sections:**

#### How to use it

**Body:** Start from the device's intended purpose, not its technology. Search for the rule groups that match: non-invasive, invasive, active, software or special rules. List every rule that could apply, read the full Annex VIII text for each candidate, and record the one that gives the highest class. Export the table to Excel and add a column for your rationale to keep as part of the classification record in the technical documentation.

**Bullets:**

- Classify on intended purpose and duration of use
- Check all potentially applicable rules
- The highest resulting class wins
- Record the rationale in the technical file

#### The structure of Annex VIII

**Body:** Annex VIII has implementing rules followed by classification rules in four groups: non-invasive devices (rules 1 to 4), invasive devices (5 to 8), active devices (9 to 13) and special rules (14 to 22). Duration of use (transient, short-term, long-term), invasiveness, and whether a device is active or reusable are the main variables. Rule 11 for software is widely discussed because most diagnostic or decision software is now Class IIa or above.

#### Worked example

**Body:** A reusable surgical instrument for transient use would be considered under Rule 6 and further conditions for reusable surgical instruments. A software application that gives dosing recommendations used to make therapeutic decisions falls under Rule 11 and the class rises with the severity of harm that wrong information could cause. A sterile wound dressing falls under Rule 4 and its class depends on the wound type.

#### Common mistakes

**Body:** Frequent errors include classifying by analogy to a US product code, ignoring a rule because another one already applies, forgetting that accessories are classified in their own right, and not revisiting the classification after a change in intended purpose. Document the intended purpose precisely, because the class follows from it.

**Cta:** If you want device class, intended purpose and technical documentation status tracked next to your product master in the ERP, Netray can discuss how that could be set up.

**Faq:**

#### Can I rely on this table to classify my device?

**Answer:** Use it as an orientation. The legal text of Annex VIII and MDCG guidance control the outcome, and a notified body can disagree with a self-assessment. Confirm borderline decisions with a regulatory specialist.

#### What if two rules apply?

**Answer:** The implementing rules state that where several rules apply to the same device, the strictest rule resulting in the higher classification applies. Record each candidate rule and why it did or did not drive the class.

#### How is software classified?

**Answer:** Rule 11 covers software intended to provide information for diagnostic or therapeutic decisions or to monitor physiological processes, with the class depending on the potential harm. Software that drives or influences a device follows the class of that device.

#### Does the class affect the CE marking route?

**Answer:** Yes. Class I (non-sterile, no measuring function, non-reusable surgical) is largely self-declared, while higher classes and Class I devices with sterile, measuring or reusable surgical features involve a notified body to varying degrees.

## Search terms

eu mdr classification rules, mdr annex viii rules 1-22, mdr rule 11 software classification, mdr class iia iib iii rules, medical device classification eu, mdr rule 8 implantable, mdr classification table, ce marking device class

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