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The 58% line: five takeaways the EU sweep
Different rules, same exam. A listing that fails a GPSR sweep would fail under the MDR as well.
35
1,700+
products checked
May–July 2026
May–July 2026
58%
fully compliant
the pass mark
the pass mark
560
corrective orders
published September
published September
01
Fact
They checked the page, not the product
Inspectors opened the listing and looked for three things: who made it, who is responsible inside the EU, and how the unit can be traced. All 42% of failures came down to missing or mismatched information.
Legal basis: Regulation (EU) 2023/988 (GPSR), directly applicable in all 27 member states since 13 December 2024.
02
What changed
Three shifts, all about people and information
Directive became regulation — one rulebook, no national transposition. Platforms entered the chain — a regulatory contact point must be registered in Safety Gate, and takedown orders executed within two working days. Own-branding makes you the manufacturer — reselling under your own label changes your legal identity.
03
Key point
Devices are out of scope — the exam is identical
Article 2 of the GPSR excludes medical devices, which fall under the MDR/IVDR. Yet each of the four checks has a precise MDR anchor:
| What inspectors verified | MDR anchor |
|---|---|
| Manufacturer name, address, electronic contact | Annex I, 23.4; EUDAMED actor registration (SRN) |
| A responsible person established in the EU | Article 11 authorised representative — name and address on label, IFU or website |
| Product identification (model / lot / serial) | UDI-DI and Basic UDI-DI, entered into EUDAMED |
| Warnings and safety information | Annex I, 23.4 — in the official language of the member state of sale |
The same four items must be delivered twice for a device: once printed on the product, once recorded in EUDAMED and the platform back end.
04
Risk
A certificate answers "is it safe", not "who do we call"
CE marks cover specific directives; an MDR certificate does not prove that you appointed an authorised representative, assigned a UDI, registered in EUDAMED or prepared multilingual labelling.
Cheap representative services fail on sight, usually missing all four: a written mandate, custody of the technical file, response to enquiries, and uniqueness. Where one address hosts a thousand clients, one failure drags them all down.
05
Timing
Sweeps are random. Registration is not.
The four EUDAMED modules become mandatory on 28 May 2026; legacy-device backfill works back from 28 November 2026, with submission by 26 November at the latest. Whether you get inspected is luck; whether you are registered is a record.