What risk class does my device belong to and what is the consequence?

The MDR introduces different risk classes for medical devices, based on the potential risk to the patient and user. The risk classes determine the level of monitoring and assessment manufacturers must undergo to comply with the MDR. This helps ensure patient and user safety.

What are the risk classes?

Below are the different risk classes stated with examples for software as medical device[1].

  • Risk Class I: Lowest risk, simple devices such as an app to higher chance on conception by calculating the user’s fertility status based on a validated statistical algorithm. Within Class 1, a device may fall into a specific subcategory:
    • Class 1 measurement function: lowest risk devices that serve to measure or detect physiological parameters, such as body temperature, blood pressure. These devices are not invasive in nature and are intended for use outside the body.
    • Class 1 sterile: devices that must be sterile before use, such as sterile dressings, gauze, catheters and hypodermic needles.
  • Risk class IIa: Moderate risk, such as a serious game with virtual reality glasses where a specialists determines the necessary cognitive therapy bases on the outcome.  
  • Risk class IIb: Considerable risk, such as an app that detects abnormalities in an user’s heartbeat to inform a physician.
  • Risk class III: Highest risk, for example image analysis intended to perform diagnosis for making treatment decisions in patients with acute stroke.

How does the classification go?

To do the classification, follow step-by-step the classification rules in Annex VIII of the MDR. Similar to the qualification process: document the findings. If more than one classification rule applies to your product, go with the highest classification. More information and visual flow charts are in the European Commission guidance[2].

What effect does the height of the class have?

The biggest consequence of the class is the extent of testing by a notified body in conformity assessment procedure (see Annexes IX to XI). The degree of intensity of the notified body’s review affects product certification costs and review turnaround times. Check the following reports to get an idea of this:

In addition, the class affects requirements on the manufacturer regarding clinical trials[4], UDI[5] and post-market surveillance[6].

 Class 1Class 2aClass 2bClass 3
NB conformity assessmentNo, the manufacturers notifies the device via EUDAMED or CIBG /Farmatec NOTIS[7]  Yes, conformity assessment by reviewing the technical documentationYes, extensive conformity assessmentJa, thorough conformity assessment including clinical evaluation
NB review times 2022 (see MedTech Europe Survey Report – MedTech Europe)If applicable, average between 6 and 18 monthsOn average between 6 and 18 monthsOn average between 10 and 19 monthsOn average between 13 and 24 months
Clinical investigation in clinical evaluationClinical evaluation planClinical evaluation planClinical evaluation plan (clinical investigation required for implants)Clinical evaluation plan with additional requirement of clinical investigation
UDITransition period after MDRMandatory from start MDR
Post market surveillancePost market surveillance planPost market surveillance plan with periodic safety report to NB 1x/2 yearsPost market surveillance plan with periodic safety report to NB 1x/2 yearsPost market surveillance plan with periodic safety report to NB 1x/year

[1] For more guidance, see MDCG 2021-24: Guidance on classification of medical devices.

[2] For more guidance, see MDCG 2021-2 Guidance on classification of medical devices and MDCG 2019-11 Guidance on Qualification and Classification of Software.

[3] See an estimation of the costs page 77 ‘Table 18 Estimation of resource needs’, where the first row is the notified body cost (‘Out of pocket cost’). Note that this is a general estimate and may vary for your product development.

[4] Art. 61 to 63 and Annex XV MDR.

[5] Art. 27 MDR.

[6] Art. 85 and 86 MDR.

[7] See for the notification: Medical devices and in vitro diagnostic medical devices | Farmatec). Note, device with measurement function, reusable or sterile needs assessment NB of technical file for these parts.

Partners dhealth

Bringing Digital Health to Life!

Eyssoniusplein 18, 9714 CE Groningen The Netherlands
email | +31614977343

In samenwerking met: