## Lead with the conclusion: misclassification is more common than failing tests
When selling products with therapeutic, monitoring, or alleviating functions on Amazon Europe (EU MDR applies outside the UK, UK MDR applies in the UK), platform review will require a CE-MDR certificate (Regulation (EU) 2017/745, the EU Medical Device Regulation, which governs how medical devices are classified, assessed, and CE-marked). Most delistings are not because the product fails, but because the seller initially listed it under "small appliance" or "beauty device" categories without making a classification determination. The reference timeline for CE-MDR is 90–365 working days, and the reference cost range is 30,000–200,000 RMB. The wide range is because classifications differ and whether a Notified Body (an EU-authorised issuing body) needs to be involved differs. Determining classification first, then discussing testing, is the only way to control costs.
## Step 1: Determine classification first, then decide whether an NB is needed
MDR classifies devices into four classes: I, IIa, IIb, and III, with the rules set out in Annex VIII. The boundaries sellers most often get wrong are:
| Product example | Common misjudgement | Actual classification tendency under MDR | Whether a Notified Body is needed | | --- | --- | --- | --- | | Ordinary massager (muscle relaxation only) | Medical device | May not be a medical device | Not needed | | RF beauty device (acts on skin) | Small appliance | Often assessed as Class IIa | Usually needed | | Infrared thermometer | Electronic thermometer | Class IIa | Needed | | Hearing aid type | Consumer electronics | Class I or IIa, depending on function | Depends on classification | | Contact lens care solution | Daily chemical | Determined on the device or drug-device boundary | Depends on classification |
The rule of thumb is: first look at the intended purpose (the sentence the manufacturer writes in the instructions and on the packaging), then look at whether it acts on the human body and whether the mode of action is invasive or penetrating. If the intended purpose sentence is written incorrectly, all subsequent documentation must be redone.
## Step 2: Class I also requires technical documentation and registration
Many sellers think that for Class I, "self-declaration" is all that is needed. Under MDR, Class I still requires: Technical Documentation, a Declaration of Conformity (DoC), an EU responsible person, and registration in countries where required. The only difference is that no NB-issued certificate is needed. In practice, SWTC usually proceeds in four stages: "classification determination—technical documentation preparation—testing submission—DoC signing." Testing is carried out by partner laboratories with CNAS/CMA or equivalent qualifications; technical documentation is organised and prepared by us and ultimately signed by the manufacturer.
## Step 3: Platform appeal documentation checklist
After delisting, the materials generally submitted to the platform include: CE-MDR certificate or Declaration of Conformity, classification determination statement, technical documentation table of contents, labels and instructions (including EU responsible person information), and test reports. The materials must corroborate each other; in particular, the model naming, manufacturer name, and intended purpose wording must be consistent in all three places. This is a frequent reason for rejection.
## Step 4: How to. Send your email here and we will reply with the scheme, timeline and cost range.
Issued by a notified body (NB) or an institution authorised by the standards authority of the destination country. The lead times and fees on this page are public industry reference ranges; actual figures are subject to engineer assessment and institution scheduling. ## One-sentence conclusion For selling medical device products on Amazon Europe, determining the classification under MDR Annex VIII first and then deciding whether to engage a notified body will save at least half the time and cost compared with doing testing first and supplementing the classification afterwards. Send your email here and we will reply with the scheme, timeline and cost range.