Early device classification is essential, especially if you have a complex or invasive device that you suspect is of higher risk. In the EU, classification influences the type of conformity assessment required and the level of the involvement of the Notified Body required to obtain CE Marking, which is required to legally market your device. Once you confirm your device’s classification, you can plan a more efficient (and successful) regulatory submission. In this blog, we’ll show you how to classify your medical device under EU Medical Devices Regulation 2017/745 (EU MDR) and what each classification means for your route to CE Marking. 

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How to Navigate EU Medical Device Classification Under the EU MDR 

Under the EU MDR, medical devices are categorized into four classes: 

The EU MDR uses a set of 22 rules to assign classification to a device, which are found in Annex VIII Chapter III of the MDR. The Medical Device Coordination Group (MDCG) Guidance on classification of medical devices provides more detailed explanations and rationale for how each rule should be interpreted and applied in practice. The rules are grouped into four categories: 

The rules follow an “if this, then that” logic. To classify your device, you will find the rule that applies to your device based on its intended use and indications for use. If more than one rule applies, you must choose the rule with the higher risk association.  

For example, Rule 11 addresses classification of medical device software. According to the rule, software “intended to provide information which is used to make decisions with diagnosis or therapeutic purposes” is a Class IIa device. However, if the diagnostic decision could result in death or irreversible decline in health, the device is a Class III. MDCG Guidance on Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR cites melanoma image analysis software intended to be used with a near-infrared laser light scanner as an example of this scenario. In the case of an aggressive disease like melanoma, an inaccurate or delayed diagnosis could be fatal. 

Overview of EU Medical Device Classification and Regulatory Requirements 

EU classification may seem familiar if you’re already selling your device in other markets. Many regulators use a similar concept and tier system, while others directly reference the EU MDR’s classification scheme. Let’s look at each classification and its regulatory requirements in more detail: 

Class I – low risk 

Class I devices are considered to have minimal risk to the patient or user. They are generally non-invasive and, therefore, have the fewest requirements for EU conformity assessment. Examples of Class I devices include bandages or crutches. 

Class I devices must fulfill these requirements: 

• • Post-Market Surveillance (PMS) Plan and PMS Report 

• • Clinical Evaluation Report 

• • Post-Market Clinical Follow-up (PMCF) Plan and PMCF Report 

• • Technical documentation (Class Is and Im) 

• • Quality management system (QMS) 

Many Class I devices can self-certify without Notified Body review. However, there are three sub-classifications under Class I that do require Notified Body involvement: 

• • Class Is – device is provided sterile (e.g., examination gloves) 

• • Class Im – device has a measuring function (e.g., thermometer) 

• • Class Ir – device is a reusable surgical device (e.g., scalpel) 

Class IIa – Moderate Risk 

Class IIa devices are considered higher risk than Class I devices. This class includes invasive devices that are implanted in the body for more than 60 minutes and less than 30 days, such as a hearing aid or catheter.  

In addition to requirements outlined for Class I devices, Class IIa devices require a EU technical documentation assessment certificate from a Notified Body and do not have the option to self–certify. They must also provide a Periodic Safety Update Report (PSUR) in lieu of a PMS Report. Class IIa and higher devices must also prepare a Summary of Safety and Clinical Performance (SSCP), which is designed to provide users and providers with a clinical overview of the product. 

• • EU Technical Documentation Assessment Certificate from a Notified Body 

• • Post-Market Surveillance (PMS) Plan and PSUR  

• • Clinical Evaluation Report 

• • Post-Market Clinical Follow-up (PMCF) Plan and PMCF Report 

• • Summary of Safety and Clinical Performance (SSCP) 

• • Technical documentation  

• • Quality management system (QMS) 

Class IIb – Moderate-High Risk  

Class IIb includes moderate risk and some high-risk devices that are implanted in the body for longer than 30 days. This device class also includes some complex devices like ventilators and incubators. Regulatory requirements for Class IIb devices are similar to requirements for Class IIa devices: 

• • EU Technical Documentation Assessment Certificate from a Notified Body 

• • Post-Market Surveillance (PMS) Plan and PSUR  

• • Clinical Evaluation Report 

• • Post-Market Clinical Follow-up (PMCF) Plan and PMCF Report 

• • Summary of Safety and Clinical Performance (SSCP) 

• • Technical documentation  

• • Quality management system (QMS) 

Class III – High-Risk 

Class III includes devices that support human life or play a significant role in preventing impairment of human health. They are often complex and may connect directly with the central nervous or circulatory systems. As a result, they may pose an unreasonable potential risk of illness, injury, or death. Examples include breast implants and cardiovascular stents. 

Conformity assessment procedures for Class III devices are rigorous and require the highest level of involvement from a Notified Body. They often require clinical investigations and extensive pre-market clinical data. Class III devices also require a full quality management system audit:

• • EU Technical Documentation Assessment Certificate from a Notified Body 

• • Post-Market Surveillance (PMS) Plan and PSUR  

• • Clinical Evaluation Report 

• • Post-Market Clinical Follow-up (PMCF) Plan and PMCF Report 

• • Summary of Safety and Clinical Performance (SSCP) 

• • Technical documentation  

• • Quality management system (QMS) audit 

MedEnvoy can Classify Your Medical Device in Europe 

The EU MDR’s classification rules are explicit in some cases and more abstract in others. Rules that separate a moderate-risk device from a high-risk device can be difficult to quantify. Manufacturers can be reluctant to take on the conformity assessment requirements of a higher risk device, which can be time consuming and expensive. But it saves time and money long term to identify the correct classification as early as possible. MedEnvoy’s team of regulatory experts has decades of experience classifying medical devices and deep expertise with the EU MDR. We can perform an in-depth classification assessment and create a strategy for fulfilling your conformity assessment requirements to contact us, click here.

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