EU Medical Device Classes Guide – Class I, IIa, IIb, and III

The Medical Devices Regulation sets requirements according to device class. More specifically, medical devices are defined as class I, IIa, IIb, or III. In turn, this determines certain requirements, and which conformity assessment procedure the manufacturer must follow.

In this guide, we present the different classes for medical devices, explain how medical devices must be classified, delve into the classification rules, and explore the implications of each classification.

Classification rules for medical devices

The Medical Devices Regulation requires medical devices to be classified into one of the four classes:

• Class I devices
• Class IIa devices
• Class IIb devices
• Class III devices

This is necessary to confirm the conformity assessment procedure which needs to be undertaken as not all classes share the same conformity assessment procedure. Additionally, the class of the device affects the labelling information accompanying the product.

The conformity assessment procedure explains the route that manufacturers should take to demonstrate that their product conforms to the requirements of the Medical Devices Regulation. Note that some conformity assessment procedures specify the involvement of a notified body.

A medical device’s class can be determined if it satisfies the relevant rules contained in Annex VIII of the Medical Devices Regulation. Below we provide some examples of the classification rules taken from the regulation, which classes they are related to, and their description.

Rule	Class	Description
Rule 1	Class I	This rule states that non-invasive devices are classed as Class I devices unless another rule states otherwise.
Rule 12	Class IIa, Class IIb	This rule states that active devices used to administer or remove substances (e.g. medicinal products) to or from the body are classed as Class IIa devices. However, it would be classified as Class IIb if the active device functions in a potentially hazardous manner.
Rule 19	Class III	This rule states that devices using nanomaterials that present a high or medium potential for internal exposure are classified as Class III devices.

The European Commission published a guide on the classification rules, which includes examples of products related to each rule. To view the guide, enter into the European Commission’s site containing guidance documents concerning the Medical Devices Regulation and search for the document entitled “Guidance on classification of medical devices”.

The section entitled “4.2 General explanation of rules/practical issues/examples” in the guide contains an explanation of each classification rule.

Class I medical device

This section highlights the classification rules related to Class I medical devices, provides product examples, and covers the conformity assessment procedure required.

Classification rules

The following rules are relevant to a Class I determination for a medical device:

• Non-invasive devices (rules 1, 2, and 4)
• Invasive devices (rules 5 and 6)
• Active devices (rules 10, 11, and 13)
• Special rules (rule 18)

Product examples

The following are examples of Class I medical devices and the applicable classification rule:

• Stethoscopes (Rule 1)
• Corrective spectacle frames (i.e. glasses) and lenses in frames (Rule 1)
• Cups and spoons specifically intended for administering medicines (Rule 2)
• Sticking plasters (Rule 4)
• Examination gloves (Rule 5)
• Scalpels and scalpel handles (Rule 6)

Requirements

The following Class I devices should adhere to the conformity assessment procedure in Annex IX or Annex XI if they:

• Are sold in a sterile condition
• Have a measuring function
• Are reusable surgical instruments

For all other class I devices, the regulation only specifies the issuance of the Declaration of Conformity and technical documentation.

Summary

Requirement	Notes
Notified body’s identification number label	Class I devices (sterilized devices, devices with measuring functions, or reusable surgical instruments) The notified body identification number needs to be displayed along with the CE mark Other Class I devices Not required
Documentation	Class I devices (sterilized devices, devices with measuring functions, or reusable surgical instruments) The required documents vary depending on the conformity assessment procedure selected. Examples of required documentation include: a. Declaration of conformity b. Technical documentation c. Test reports Other Class I devices a. Declaration of Conformity b. Technical documentation
Notified body	Class I devices (sterilized devices, devices with measuring functions, or reusable surgical instruments) Required Other Class I devices Not required
Other requirements unique to Class I devices	Preparation of a post-market surveillance report is required

Class IIa medical devices

This section highlights the classification rules related to Class IIa medical devices, provides product examples, and covers the conformity assessment procedure required.

Classification rules

The following rules are relevant to a Class IIa determination for a medical device:

• Non-invasive devices (rules 2 – 4)
• Invasive devices (rules 5 – 8)
• Active devices (rules 9 – 12)
• Special rules (rules 16 – 17 and 19 – 21)

Product examples

The following are examples of Class IIa medical devices and the applicable classification rule:

• Syringes for infusion pumps (Rule 2)
• Short term corrective contact lenses (Rule 5)
• External hearing aids (Rule 9)
• Digital x-ray detectors for recording images (Rule 17)
• Dental filling materials (Rule 19)

Requirements

Class IIa devices should adhere to the conformity assessment procedure specified in either:

a. Annex IX

b. Annex XI

Summary

Requirement	Notes
Notified body’s identification number label	The notified body identification number needs to be displayed along with the CE mark
Documentation	Annex IX There are numerous types of documentation specified in the Annex. Examples of required documentation include: a. Declaration of conformity b. Technical documentation c. Test reports d. Documentation on the manufacturer’s post-market surveillance system e. Documentation on the clinical evaluation plan Annex XI There are numerous types of documentation specified in the Annex. Examples of required documentation include: a. EU type-examination certificate b. Technical documentation c. EU declaration of conformity
Notified body	Required
Other requirements unique to Class IIa devices	1. A summary of safety and clinical performance to be drawn up for implantable devices is required 2. A periodic safety update report is required

Class IIb medical devices

This section highlights the classification rules related to Class IIb medical devices, provides product examples, and covers the conformity assessment procedure(s) required.

Classification rules

The following rules are relevant to a Class IIb determination for a medical device:

• Non-invasive devices (rules 2 – 4)
• Invasive devices (rules 5 – 8)
• Active devices (rules 9 – 12)
• Special rules (rules 15 – 16 and 19 – 21)

Product examples

The following are examples of Class IIb medical devices and the applicable classification rule:

• Dressings intended for burns having breached the dermis (Rule 4)
• Long term corrective contact lenses (Rule 5)
• Lung ventilators (Rule 9)
• Condoms and femidoms (Rule 15)
• Eye drops for hydration (Rule 21)

Requirements

Class IIb devices should adhere to the conformity assessment procedure specified in either:

a. Annex IX

b. Annex X and Annex XI

Summary

Requirement	Notes
Notified body’s identification number label	The notified body identification number needs to be displayed along with the CE mark
Documentation	Annex IX There are numerous types of documentation specified in the Annex. Examples of required documentation include: a. Declaration of conformity b. Technical documentation c. Test reports d. Documentation on the manufacturer’s post-market surveillance system e. Documentation on the clinical evaluation plan Annex X and Annex XI There are numerous types of documentation specified in the Annex. Examples of required documentation include: a. EU type-examination certificate b. Technical documentation c. EU declaration of conformity d. Scientific opinions and reports e. Test reports
Notified body	Required
Other requirements unique to Class IIb devices	1. A summary of safety and clinical performance to be drawn up for implantable devices is required 2. A periodic safety update report is required

Class III medical devices

This section highlights the classification rules related to Class III medical devices, provides product examples, and covers the conformity assessment procedure(s) required.

Classification rules

The following rules are relevant to a Class III determination for a medical device:

• Non-invasive devices (rule 3)
• Invasive devices (rules 6 – 8)
• Active devices (rules 9 and 11)
• Special rules (rules 14, 15, 18, 19, 21, and 22)

Product examples

The following are examples of Class III medical devices and the applicable classification rule:

• IVF cell media without human albumin (Rule 3)
• Cardiovascular catheters (Rule 6)
• Remote monitoring devices for active implantable devices (Rule 9)
• Bone cement with antibiotics (Rule 14)

Requirements

Class III devices should adhere to the conformity assessment procedure specified in either:

a. Annex IX

b. Annex X and Annex XI

Summary

Requirement	Notes
Notified body’s identification number label	The notified body identification number needs to be displayed along with the CE mark
Documentation	Annex IX There are numerous types of documentation specified in the Annex. Examples of required documentation include: a. Declaration of conformity b. Technical documentation c. Test reports d. Documentation on the manufacturer’s post-market surveillance system e. Documentation on the clinical evaluation plan Annex X and Annex XI There are numerous types of documentation specified in the Annex. Examples of required documentation include: a. EU type-examination certificate b. Technical documentation c. EU declaration of conformity d. Scientific opinions and reports e. Test reports
Notified body	Required
Other requirements unique to Class III devices	1. There are specific recordkeeping requirements concerning the unique device identification (UDI) of Class III implantable devices 2. A summary of safety and clinical performance is required 3. A periodic safety update report is required