Product class
Is a health wearable an important product under the CRA?
Short answer: Yes, as a category. A health wearable is listed in Annex III, Class I, item 19. Under Article 7(1), a product whose core functionality is that of a listed category is an important product, so whether your product is one depends on its core functionality.
“Personal wearable products to be worn or placed on a human body that have a health monitoring”
Technical description
Commission Implementing Regulation (EU) 2025/2392 gives the technical description of each category in the annexes. It says what the category covers, in the Official Journal's words.
“Personal wearable products to be worn or placed on a human body that have a health monitoring purpose are products with digital elements that are worn on the body directly or via clothing or accessories and that can, regularly or continuously, sense and further process information, including body metrics, relevant to the user’s health, excluding products that fall within the scope of Regulation (EU) 2017/745 or of Regulation (EU) 2017/746.
This category includes but is not limited to fitness trackers, smartwatches, smart jewellery, smart clothing and sports apparel that meet this description.
Personal wearable products that are intended for the use by and for children are products with digital elements which can be worn or placed on the body, directly or via clothing or accessories, of individuals under the age of 14.
This category includes but is not limited to child safety wearables.”
What Class I means for the conformity route
Article 32(2) caveat: self-assessment via internal control remains available only if you apply in full harmonised standards, common specifications or European cybersecurity certification schemes at assurance level at least 'substantial'; where you apply them only in part or not at all, or none exist, EU-type examination followed by production control (module B+C) or full quality assurance (module H) applies.
The wording of Article 32(2) is quoted in the product classes guide.
When it applies
Since 11 June 2026, the rules on notified conformity assessment bodies, Chapter IV (Articles 35 to 51), have applied. The reporting duties of Article 14 have applied since 11 September 2026. The CRA will apply in full from 11 December 2027. The wording of the application clause is quoted in the product classes guide.
Edge cases
- Free and open-source software. Article 32(5) has its own rule for Annex III products. The wording of Article 32(5) is quoted in the product classes guide.
- The core functionality decides. Check your product's core functionality against the annex text quoted above. The wording of Article 7(1) is quoted in the product classes guide.
Questions and answers
Where does a health wearable sit in the CRA annexes?
See the short answer and the annex quote at the top of this page.
Does a health wearable need a notified body?
Not in every case: internal control stays open only where the Article 32(2) conditions are met, as the route section above sets out.
When do the CRA rules for a health wearable apply?
Reporting duties under Article 14 have applied since 11 September 2026, and the CRA will apply in full from 11 December 2027.
Cybiq checks the CRA only. Orientation, not legal advice. Quoted spans come from Regulation (EU) 2024/2847 as published in the Official Journal and are re-verified against the live text by automated tests. Verify before relying on any item; for an assessment of your own product, consult a qualified lawyer.