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.
Some helpful tips, before starting your classification assessment, are included below.
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.
If you would like further information or advice on how the regulations apply to your specific device contact Casus Consulting directly. 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.
This tool should be used only after you have determined the product is considered a medical device, based on the definition in EU MDR Article 2(1). If you need help determining if your product is considered a medical device, the regulatory authorities in Hong Kong (Medical Device Division – MDD) and Singapore (Health Sciences Authority – HSA) have online tools that can assist (linked below).
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.
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 when reviewing the intended use against the questions in 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.
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.
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.
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 providecontext. However, MDCG 2021-24 can also be referenced 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 using the chat feature on the bottom right corner of this page or the Contact Us form.
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