Why we do not call our blankets a medical device
Browsing weighted blanket listings, you keep running into the phrase “Class I medical device”. It sounds serious and builds trust — which is exactly why it is used so freely. We do not use it, and not because we have not got round to it. It is a deliberate decision. Here is what that status actually means.
What a medical device is in law
The definition comes from Regulation (EU) 2017/745, known as the MDR. It is not a marketing label but a legal status carrying specific obligations:
- Clinical evaluation. The manufacturer must document that the device performs as claimed, based on clinical data rather than user opinion.
- Technical documentation and a quality management system maintained across the product's life cycle.
- Registration in EUDAMED — the public European database of medical devices, with a number anyone can check.
- Post-market surveillance — collecting and reporting adverse events.
- For classes above I, also involvement of a Notified Body — an independent organisation that verifies the documentation.
Where the misunderstanding happens
The most common source of confusion is a declaration of conformity issued by the manufacturer. It is often presented as proof of certification, but it is not — it is a company's statement about itself. A Notified Body certificate is a different document entirely, issued by an external party.
The second confusion involves the word “therapeutic”. Unlike “medical device” it is not legally protected, so it gets used interchangeably — and the reader hears the same thing: “this treats something”. The difference matters, because nothing verifiable stands behind the first term.
How to check it in two minutes
This is not expert knowledge, just a few steps worth taking with any purchase in this category — including ours.
- Look on the product page for a EUDAMED number or a Notified Body certificate number. “MDR compliant” on its own is not enough.
- Check whether the claimed effect concerns a specific medical condition. A sentence like “supports the treatment of depression” is a medical claim requiring documentation.
- See which material certificates the seller lists. OEKO-TEX STANDARD 100 covers harmful substances in textiles — real and verifiable, but not the same as medical status.
- Read the returns policy. EU distance selling grants a minimum of 14 days to withdraw. If a seller makes that difficult, the rest of their claims matter less.
Our position
A Pandreamora weighted blanket is a wellness product. It supports sleep comfort and winding down in the evening. It is not a medical device, it does not treat sleep disorders, and it does not replace consultation with a specialist.
That is not a cautious footnote — it is a description of what we actually offer. We chose this position for three reasons. It is true, and requires no linguistic gymnastics. It covers a wider audience: not only people with a diagnosis, but anyone who wants to sleep better. And it is resilient to regulatory change, because it does not rest on a status we do not hold.
What we can state concretely: we sew in Poland, we use OEKO-TEX STANDARD 100 certified cotton, we fill with glass microbeads rather than polymer granulate, and we size by the rule of roughly 10 percent of body weight. Every one of those sentences can be checked.
Frequently asked questions
Does this mean weighted blankets do not work?
No. Research on sleep and deep pressure produces promising results — we cover it in a separate article. The point is different: “improves sleep comfort” and “is a medical device” are two different sentences, and only the second carries legal consequences.
Is OEKO-TEX a medical certificate?
No. OEKO-TEX STANDARD 100 confirms that textiles have been tested for harmful substances. It certifies material safety, not health effectiveness.
Can I use a weighted blanket if I have a diagnosis?
That is a question for your doctor, not a retailer. With respiratory or circulatory conditions, or difficulty moving unaided, consultation is advised.
Summary
“Medical device” is a legal status with concrete requirements: clinical evaluation, documentation, a EUDAMED number and post-market surveillance. A manufacturer's declaration does not substitute for it. We do not use the term because we do not hold the status — and we talk instead about things that can be verified: Polish manufacturing, material certificates and weight fitted to the person.
Sources
- Regulation (EU) 2017/745 on medical devices (MDR)
- EUDAMED — European Database on Medical Devices, ec.europa.eu
- OEKO-TEX STANDARD 100 — harmful substance testing criteria
- Directive 2011/83/EU on consumer rights — 14-day right of withdrawal
See also
- Aura ComfortCrinkled satin, OEKO-TEX certified cotton
- Frequently asked questionsMaterials, certificates, returns
- Right of withdrawalHow returns work
We talk about comfort, because comfort is what we know
Instead of a status we do not hold, here is what we do hold: OEKO-TEX STANDARD 100 certified cotton, sewing in Poland, and 14 days to return. The Aura line — Comfort, Family and Kids in crinkled satin — is the latest example. Sewn in Poland. Courier or InPost parcel locker delivery, 14 days to return, free weight exchange within that period.
This article is informational and concerns sleep comfort and general wellbeing. A weighted blanket is not a medical device and does not replace consultation with a specialist.