EU Medical Device Classification – RAPS

Determining the correct classification and applicable rule for a medical device is the essential first step in the CE marking process. This classification not only influences the level of regulatory scrutiny but also dictates the structure of the technical documentation and whether involvement of a Notified Body is required.

Under Article 51 of the EU Medical Device Regulation (MDR), medical devices are classified into four risk-based categories: Class I, IIa, IIb, and III. These classes reflect the intended purpose of the device and its potential risk to patients and users, with risk increasing progressively from Class I to Class III.

Both the former Medical Device Directive (MDD) and the current Medical Device Regulation (MDR) follow a rule-based classification system. The MDR significantly expands this framework, introducing 22 classification rules outlined in Annex VIII, offering greater clarity and precision in assigning the correct class.

RAPS provides expert guidance in interpreting and applying these rules, helping you ensure compliance from the outset of your product’s EU market journey.

EU MDR Classification – By Body Placement and Duration of Use

Classification Based on Body Placement

Non-Invasive Devices
These devices operate externally and do not enter the body. Due to their lower risk profile, they are typically classified as Class I or Class IIa under the EU MDR.
Invasive Devices
Devices that penetrate the body, either through natural or artificial openings or by breaching the skin, are considered higher risk. These are generally classified as Class IIb or Class III.
Active Devices
These rely on external energy sources—such as electricity, batteries, or chemical reactions—to function. Depending on their intended use and risk level, active devices usually fall under Class IIb or Class III.

Classification Based on Duration of Use

Transient Use
Devices intended for continuous use of less than 60 minutes.
Short-Term Use
Devices intended for continuous use of between 60 minutes and 30 days.
Long-Term Use
Devices designed for continuous use exceeding 30 days.

Understanding how your device’s interaction with the body and duration of use affects its classification is essential for CE marking. RAPS provides the expertise to navigate these distinctions and ensure regulatory compliance from the start.

EU Medical Device Classification – Examples and Risk Levels

Medical devices are classified under the EU MDR based on their risk level, intended use, and other factors such as invasiveness and duration of contact with the body. Below are examples and certification pathways for each classification:

Class I – Low Risk

Examples:
- Corrective glasses and frames
- Manual wheelchairs
Certification Path:
- Self-Certification (No Notified Body required unless involving sterile, measuring, or reusable features)

Subcategories of Class I:

Class Is – Sterile devices (e.g., sterile dressings)
Class Im – Measuring function (e.g., thermometers)
Class Ir – Reusable surgical instruments

Class IIa – Medium Risk

Examples:
- Dental fillings
- Hearing aids
- Suction equipment
Certification Path:
- Requires involvement of a Notified Body

Class IIb – Medium to High Risk

Examples:
- Lung ventilators
- Bone fixation plates
- Long-term infusion pumps
Certification Path:
- Requires a more detailed assessment by a Notified Body

Class III – High Risk

Examples:
- Heart valves
- Implantable pacemakers
- Breast implants
Certification Path:
- Most rigorous review by a Notified Body, including clinical evaluation and full technical documentation

EU Medical Device Classification Rules – Overview

The EU Medical Device Regulation (EU MDR 2017/745), specifically Annex VIII, outlines a set of 22 classification rules used to determine the appropriate risk class of a medical device. These rules take into account the device’s characteristics, including how it interacts with the human body and its intended purpose.

Rules 1–4: Non-Invasive Devices

Primarily cover devices that do not enter the body. These are usually classified as Class I, but depending on the risk and function, they may also fall under Class IIa, IIb, or even Class III.

Rules 5–8: Invasive Devices

Apply to devices that penetrate the body via an orifice or the skin. These are generally classified as Class IIa, IIb, or III, though some lower-risk invasive devices may still be classified as Class I.

Rules 9–13: Active Devices

Concern devices that operate with an external power source (e.g., electrical, battery). These may fall under Class I through Class III, depending on their invasiveness, duration of use, and function.

Rules 14–22: Special Rules

Cover devices with specific use cases or characteristics that require unique classification considerations. These include substances absorbed by the body, devices used for contraception, and software intended for diagnostic purposes.

Special Note: Classification of Aesthetic and Non-Medical Devices

Under Annex XVI of the EU MDR, Regulation 2017/745 includes several non-medical devices that are now regulated similarly to medical devices due to their potential risk profile, even if they lack a direct medical purpose.

Devices Now Covered Under EU MDR Include:

Cosmetic and Decorative Contact Lenses
(Including colored lenses with no corrective function)
Aesthetic Implants Without Medical Purpose
(e.g., breast implants for cosmetic enhancement)
Dermal Fillers
(Used for facial wrinkle reduction or lip enhancement)
Body Contouring Devices
(e.g., devices used for liposuction, lipolysis, and lipoplasty)
Light-Based Skin Treatment Devices
(e.g., lasers and IPL devices for hair removal, skin resurfacing, and tattoo removal)
Brain Stimulation Devices
(Devices intended to alter brain activity or mood, even for non-medical purposes)

RAPS helps manufacturers navigate these nuanced rules and special classifications, ensuring your product meets all regulatory expectations—whether it’s traditional, active, or aesthetic in nature.