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
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
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
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
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.