Medical Device Classification Tool 
This questionnaire has been designed to assist you in determining the risk classification of your medical device in accordance with the EU regulation 2017/745 on medical devices (EU MDR) and its guidance document regarding classification.

Briefly, the EU MDR includes 22 classification rules, falling into four basic categories:
- Non-invasive devices
- Invasive devices
- Active medical devices (including softwares)
- Special rules (including contraceptive, disinfectant, and radiological medical devices).

This questionnaire helps you understand the classification of your medical device, according to its features. Your answers determine the next question, aiming to assess the correct classification:
- Class I (low risk)
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)

At the end of the questionnaire (~3 min) you will get the risk classification of your device, as well as a brochure summarizing what you need to know in order to bring your idea to the market.  It serves as a helpful tool to navigate the intricate classification criteria. However, for definitive classification, it is advisable to seek guidance from regulatory experts. At CoLAB TRIALS, we support your needs on regulatory approval (regulatory roadmap, device qualification and classification, support with technical documentation and risk management) and clinical validation (clinical investigation/evaluation, support clinical evaluation planning and reporting, GSPR compliance).

Disclaimer: not applicable to in vitro diagnostics devices (IVDs), which are regulated under the EU Regulation 2017/746.

For more information, please contact geral@colabtrials.pt
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Medical Device Risk Classification

Note: The devices described below are examples for each class type.
Is your product a medical device according to the definition in the EU MDR?

"Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

- devices for the control or support of conception
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point."

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