European Union · Notified bodies · Software as a medical device
Review target
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Not published
Legal time limit
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Not published
Steps
3
7 requirements
Application fee
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Software is a medical device when the maker intends it for a medical purpose. It follows the same rules as other devices or IVDs. Rule 11 places software that informs diagnosis or treatment decisions in class IIa, IIb or III by the possible impact on health, and other software in class I. The class then decides the conformity assessment route. Software intended by its maker, alone or in combination, for a purpose in the medical device or IVD definition, either standing alone or as part of a hardware device.
1. Qualification as medical device software; 2. Classification under Rule 11 or IVD rules; 3. Conformity assessment for the class.
Outcome: Self-declaration for class I software, or a notified body certificate for higher classes.
Legal basis: Regulation (EU) 2017/745, Annex VIII, Rule 11; Regulation (EU) 2017/746; guidance MDCG 2019-11 rev.1
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in European Union: Class I devices: maker's declaration of conformity, Class I sterile, measuring or reusable surgical devices, Class IIa devices: notified body conformity assessment, Class IIb devices: notified body conformity assessment, Class III devices: notified body conformity assessment, Device with an ancillary medicinal substance: medicines authority consultation, Class A IVDs: maker's declaration of conformity, Class B IVDs: notified body conformity assessment, Class C IVDs: notified body conformity assessment, Class D IVDs: notified body assessment with EU reference laboratory. See all routes on the European Union page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.