Free EU MDR Classification Tool (2024)

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EU MDR 2017/745
Classification Tool

EU MDR 2017/745 Classification Assessment Tool. Download a free PDF of your results: EU device class & rule. Based on the MDR and MDCG guidance.

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JUMP TO MDR CLASSIFICATION TOOL

Table of Contents

The below classification tool can be used to assess the risk classification of your medical device under the EU Medical Device Regulation (MDR) 2017/745.

It is based on the classification rules detailed in Annex VIII of the MDR, along with the information included in MDCG guidance 2021-24 (‘Guidance on classification of medical devices’). Once you address the questions below, it will lead you to the likely European classification and rule for your device.

Is my product a medical device?

This tool should be used only after you have determined the product is considered a medical device. The definition is available in MDR Article 2(1).

If you need help determining if your product is considered a medical device, the regulatory authorities in Hong Kong and Singapore have online tools that can assist.

Hong Kong: Is your product a medical device?

Singapore: Is it a medical device?

It is worth noting that the regulatory schemes in each of these markets align with the old EU directives rather than the MDR. However, the definition of medical device under the directives and in these markets is very similar to the EU MDR definition. Therefore, these tools should still give you a good idea if your product is considered a medical device under current regulations.

Intended Use and Device Characteristics

The classification of your device is based on both the intended use and device characteristics. Therefore, this information must available in order to use this tool. Below are some key points from MDCG 2021-24 to consider while using the classification tool:

It is the intended, and not the accidental, use of the device that determines the class of the device.
- For instance, a suture organiser that is intended to keep suture threads used in open heart surgery in the correct order should not be considered as an invasive device if it is intended to be kept outside the patient.
- Similarly, if a healthcare professional or others uses the device in a manner not intended by the manufacturer, this does not change the class of the device for the purpose of conformity assessment.
It is the intended purpose assigned by the manufacturer to the device that determines the class of the device and not the class assigned to other similar products. For instance, two sutures that have the same composition may well have different intended purposes.

Switzerland and the UK

Switzerland

This tool can be leveraged to confirm the classification for Switzerland.

Switzerland has implemented the EU MDR into its medical device regulation: the Medical Devices Ordinance (“MedDO”). Therefore, even though Switzerland is now considered a third country in regard to medical devices, the classification for the EU is still applicable.

For more information, please read: Switzerland Steps to Market

United Kingdom

This classification tool cannot be used to determine the classification for UKCA Marking. The MHRA did not adopt the MDR/IVDR before Brexit and therefore, the classification system in Great Britain is still based on the old Directives.

Northern Ireland, the fourth UK country, continues to require CE Marking. Therefore, this classification tool can be used for Nothern Ireland.

For more information, please read: UK Steps to Market

Instructions

To get started, please answer the questions below using the dropdown selections.

Some definitions from the EU MDR and MDCG 2021-24 have been included in the workflow to provide context. However, please refer to MDCG 2021-24 for additional notes, definitions and specific device examples by classification and rule.

Once you complete the classification assessment, you can send yourself a PDF of your answers and the classification conclusion. The PDF will be emailed as an attachment and as a downloadable file.

Questions? Contact Us

Disclaimer

Casus Consulting’s classification tool is intended to provide users with an understanding of the likely classification for a specific medical device, as a starting point to entering the EU market. It is only a rough indication to be used for your internal reference. It should not be taken as a detailed description of the regulation, nor a binding confirmation of the classification based on EU MDR 2017/745.

Casus Consulting has taken due care in preparing this classification tool, but we do not guarantee, nor do we assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials.

Classification Tool

"*" indicates required fields

MDR Classification

1. Do any of the following apply to your device?*

1(a). Is the device implantable or long-term invasive?

1(b). Do either of the following apply to your device?

2. Do any of the following apply to your device?

HINT: Examples of devices intended for recording of X-ray diagnostic images are X-ray films or a digital X-ray detectors for recording images, and not an X-ray machine itself.

2(a). Is the device intended to come into contact with intact skin only?

2(b). Does the use of nanomaterials result in:

HINT: Here are some examples with devices that fall into each of the described risk level - a bone filler with nanomaterials in its formulation presents a high or medium potential for internal exposure; bone fixation screws/plates with a strongly bound nano-coating present a low potential for internal exposure; and, dental fillers present a negligible potential for internal exposure.

3. Do any of the following apply to your device?

HINT: Administration of medicinal product by inhalation refers to inhalation of the medicine into the respiratory system. For example, spacers intended for metered dose inhalers and oxygen delivery systems with nasal cannulas.

3(a). Does your device’s mode of action have an essential impact on the efficacy and safety of the administered medicinal product AND/OR the is the device intended to treat life-threatening conditions?

3(b). Do any of the following apply to your device?

4. Is your device an active therapeutic device with an integrated or incorporated diagnostic function, which significantly determines the patient management by the device?

HINT: Additional questions related to other types of active devices (i.e., rules 9 to 13 in the MDR) appear later in this questionnaire.

5. Is your device intended to be invasive?

HINT: If your device only comes into contact with injured skin or mucous membrane, please select "no" to this question.

5(a). Is the device intended to be invasive in a body orifice or stoma or is it intended to be surgically invasive?

HINT: A surgically created stoma used in urostomy, colostomy and ileostomy or permanent tracheostomy is considered to be a body orifice; therefore devices introduced into such a stoma are not surgically invasive. In contrast, a surgically created opening to allow access to the circulatory system should not be considered to be a body orifice. Devices introduced into such an opening are surgically invasive.

Examples of devices that are invasive via body orifices are corrective contact lenses, tracheal tubes, urethral stents and examination gloves (not surgical gloves). The surgically invasive definition can also apply to certain devices used in dental surgery, such as dental alloys or ceramics.

5(b). What is the duration of use?

5(c). Is your device connected to an active medical device that is class IIa or higher?

5(d). Is it only for use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity?

5(e). Is your device only for use in an oral cavity, ear canal, or in a nasal cavity and not liable to be absorbed by the mucous membrane?

5(f). What is the duration of use?

5(g). Which of the following applies to your device?

5(h). Is it a component, such as a screw, wedge plate or instrument?

6. Is it an active medical device?

HINT: Software is considered an active device. Medical devices using prestored gases and/or vacuum as a power source are also generally considered an active device if they meet the criteria in definition (detailed in the 'i' symbol). Devices that achieve their purpose through filtration and centrifugation (e.g., a hemodialyzer) are not considered active devices as they work exclusively through mechanical methods.

If your device is intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for the eventual purpose of infusion, administration or introduction into the body please select "No" to this question, as these devices are addressed later in the questionnaire. An example of this type of device is a fridge/freezer for storing blood and tissues.

6(a). Which of the following applies to your device?

HINT: If the product is a medical device software (MDSW), that does not mean that the software rule (Rule 11) automatically applies. Rules 9-13, 15 and 22 can all apply to software devices. Therefore, if you have a software device, we strongly recommend reviewing the guidance on medical device software classification (MDCG 2019-11) to best ensure the correct rule is selected. The strictest rule or sub-rule will apply.

6(b). Which of the following applies to your device?

6(c). Which of the following applies to your device?

6(d). Is it intended to monitor vital physiological parameters, where the nature of parameter variations could result in immediate danger to the patient?

6(b). Is the administration or removal of medicines or other substances from the body executed in a potentially hazardous way?

7. The device is non-invasive and non-active - which of the following applies to your device?

7(a). Do any of the following apply to your device?

Classification Result: Class I, Rule 1

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Classification Result: Class IIa, Rule 2

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Classification Result: Class I, Rule 2

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Classification Result: Class IIa, Rule 3

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Classification Result: Class IIa, Rule 3

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Classification Result: Class III, Rule 3

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Classification Result: Class III, Rule 3

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Classification Result: Class IIb, Rule 3

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Classification Result: Class IIb, Rule 3

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Classification Result: Class I, Rule 4

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Classification Result: Class IIa, Rule 4

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Classification Result: Class IIb, Rule 4

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Classification Result: Class IIa, Rule 4

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Classification Result: Class I, Rule 5

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Classification Result: Class I, Rule 5

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Classification Result: Class IIa, Rule 5

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Classification Result: Class I, Rule 5

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Classification Result: Class IIa, Rule 5

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Classification Result: Class IIb, Rule 5

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Classification Result: Class I, Rule 6

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Classification Result: Class IIb, Rule 6

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Classification Result: Class IIb, Rule 6

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Classification Result: Class III, Rule 6

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Classification Result: Class III, Rule 6

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Classification Result: Class IIa, Rule 6

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Classification Result: Class IIb, Rule 7

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Classification Result: Class IIb, Rule 7

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Classification Result: Class IIb, Rule 7

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Classification Result: Class III, Rule 7

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Classification Result: Class III, Rule 7

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Classification Result: Class III, Rule 7

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Classification Result: Class IIa, Rule 7

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Classification Result: Class IIa, Rule 8