You manufacture a WiFi smart scale that syncs body composition data to a companion app. You assumed the medical device exemption in Art. 2(1) of Delegated Regulation (EU) 2022/30 covers your product. It does not. The exemption applies only to products classified as medical devices under Regulation (EU) 2017/745 — your consumer scale is not one. Your scale connects to the internet (Art. 3(3)(d) applies) and processes personal data including body weight and body composition (Art. 3(3)(e) applies). REDCheck generates 5 PDF documents covering both requirements. 30 minutes. €99.
€99 one-time payment · 5 PDF documents in ZIP · 30 minutes · 100% in your browser
You enter your product specifications. REDCheck structures the documentation requirement by requirement.
A product is a medical device only if it has a specific intended medical purpose as defined in Art. 2(1) of Regulation (EU) 2017/745: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. A consumer smart scale marketed for wellness does NOT have a medical purpose and is NOT a medical device. No medical device classification = no exemption from RED cybersecurity.
Body weight linked to a user account (via the companion app) is personal data under Art. 4(1) of GDPR — it relates to an identified natural person. Body composition data (BMI, body fat percentage, muscle mass) is even more sensitive. Art. 1(2)(a) of Delegated Regulation (EU) 2022/30 applies Art. 3(3)(e) to internet-connected radio equipment that processes personal data.
FCC Part 15 regulates radio frequency emissions. It does not address cybersecurity, personal data protection or network protection. The EU cybersecurity requirements of Art. 3(3)(d) and (e) are entirely separate.
5 PDF documents per product model.
Art. 1, Del. Reg. (EU) 2022/30 + Art. 3(3), Dir. 2014/53/EU.
Art. 21 + Annex V.
Arts. 3(3)(d) and (e).
Art. 18 + Annex VI.
Art. 10(9) + Annex VII.
Look before you buy — Download sample dossier (PDF, fictitious product)
Generated from your data, in your browser. No product data leaves your computer.
Not a medical device. Art. 3(3)(d) and (e) apply. REDCheck generates 5 PDF documents. €99.
If your scale IS classified as a medical device, the MDR exemption applies. In that case, you need MDR compliance, not RED cybersecurity. Use the free REDCheck checker to determine your classification.
Art. 46 of Directive 2014/53/EU requires effective, proportionate and dissuasive penalties.
A WiFi smart scale processing body data faces scrutiny from both market surveillance (RED) and data protection authorities (GDPR). Two regulatory systems, two enforcement tracks.
Produktsicherheitsgesetz §19. Germany is the largest EU consumer electronics market.
Amazon EU requires cybersecurity documentation for WiFi-connected consumer products.
| Alternative | Cost | What you get |
|---|---|---|
| Health-tech regulatory consultant | $8,000–12,000 | 2–3 months. Classification + documentation. |
| Pursue medical device classification (MDR) | $50,000+ | Wrong path if product is consumer wellness. |
| Assume exemption applies | €0 | It doesn't. Non-compliance from day one. |
| REDCheck | €99 | 5 documents, 30 min |
Smart scale, fitness tracker, body composition analyzer — each model needs its own documentation. Professional Pack: €999 for 70 generations.
Request volume pricingREDCheck generates a document structured under Art. 21 and Annex V of Directive 2014/53/EU based on the information you enter. The truthfulness, accuracy and completeness of that information is your responsibility as manufacturer of the radio equipment.
We guarantee that the document structure follows Art. 21 and Annex V of Directive 2014/53/EU and that the legal references cited are correct as of the latest verification date.
REDCheck is not legal advice. For specific situations, consult a lawyer or specialised regulatory consultancy.
Five PDF documents. Art. 21 and Annex V. Directive 2014/53/EU. Your product data never leaves your computer.