What a CE Certificate Does Not Prove

A buyer in Poland asks for a quotation on examination gloves. Three offers come back, all with a CE certificate attached as a PDF. The certificates look similar: a logo, a number, a list of standards, a signature.

Two of them are worthless for the order in question, and one is real. Nothing on the page tells you which.

A CE mark is a declaration, not a licence

For most product categories, the CE mark is applied by the manufacturer on its own authority. The manufacturer writes a declaration of conformity, assembles a technical file, and puts the mark on the product. No European body approves it beforehand. Nobody checks it before it reaches the port.

That is fine for a hammer. It is not fine for a Class IIa medical device, where the law requires a notified body to audit the plant and issue a certificate before the mark can be applied.

So the first question is not “is there a certificate” but “for this product, is a notified body even required, and if so, is the number on the certificate a real one”.

The four numbers that matter

Every genuine notified body certificate carries four identifiers. Check them in this order.

What to check	Where to check it	What a fake looks like
Notified body number (four digits)	The EU NANDO database — the number must exist and the body must be designated for your product’s regulation	A number that exists but is designated for a different directive, or a body that was withdrawn years ago
Regulation cited	Should read MDR 2017/745 for medical devices placed on the market after May 2021	MDD 93/42/EEC on a device manufactured this year, presented as current
Scope of the certificate	A named product family and classification, not a category	“Medical consumables” or “all products of the company”
Validity	An expiry date, typically five years, plus surveillance audit conditions	No date, or a date that has passed with the PDF still circulating

The NANDO database is public and free. It takes ninety seconds to look up a number. In my experience of buyers who have been sold a bad certificate, almost none of them had ever opened it.

What “certificate covers the product” actually means

A factory that makes both surgical gowns and examination gloves may hold a certificate for the gowns only. The gloves are made in the same building by the same company, so the certificate gets attached to the glove quotation. It does not cover the gloves.

The scope section is written as a product family with a classification. If you cannot find your exact product described there in the terms the regulation uses, the certificate does not cover it, regardless of what the salesperson says.

The gap between the certificate holder and the plant

This is the failure that hurts most, because the paperwork is genuine.

A trading company holds the certificate and the brand. Production is subcontracted to a plant that has never been audited by the notified body. The certificate is real, the product is real, and the manufacturing site named in the technical file is not where your goods were made.

Two ways to close this gap:

Ask for the manufacturing site address as written in the technical file, then compare it to the address on the business licence of the plant you are actually buying from. They should be the same building.
Ask for the last surveillance audit report, not the certificate. The certificate is issued once and renewed every five years; the audit report is dated, usually annual, and names the site that was visited.

A supplier who can produce both within a day is a supplier who is used to being asked.

A certificate is a floor, not a ceiling

Even a perfect certificate only says the plant has a quality system that the notified body found acceptable on the day of the audit. It says nothing about the batch you are buying.

That is what pre-shipment inspection is for: sampling against AQL, sterility and packaging checks where they apply, and photographs of the cartons that will actually arrive. The certificate tells you the plant is allowed to make the product. The inspection tells you whether this shipment is the product.

For medical consumables we treat the certificate as the entry ticket and the inspection as the decision. Buyers who treat the certificate as the decision are the ones who discover the problem at the customs warehouse.

Buying medical consumables and want the certificate checked before you pay a deposit? Send us the document — we will look up the notified body and tell you what it covers.