Buyers coming into this category from cosmetics usually assume a personal lubricant is a cosmetic product. In the European Union that assumption stopped being safe in 2021. The same tube can sit under two completely different regulations, and the document set behind each route looks nothing like the other.
This is a border question, not a marketing question. If you import under the wrong assumption, the file you are holding is the wrong file.
Cosmetics are notified, not approved
Cosmetic products in the EU fall under Regulation (EC) No 1223/2009. There is no approval step and no authority signs a product off before it goes on sale. Instead a responsible person established in the EU notifies the product, keeps a Product Information File (PIF) and holds a Cosmetic Product Safety Report (CPSR) written by a qualified safety assessor. Market surveillance authorities can ask to see that file at any point.
One consequence catches people out. Cosmetics do not carry CE marking. Regulation 1223/2009 does not provide for it. When you see a CE mark on something being described to you as a cosmetic, the mark and the description contradict each other, and one of them is wrong.
Personal lubricants fall under the medical device rules
Since May 2021, when Regulation (EU) 2017/745 (MDR) became applicable, personal lubricants are treated as medical devices in the EU and classified as Class IIb. Class IIb is not a self-declaration route. A notified body has to take part in the conformity assessment and the manufacturer is audited.
That is where the CE mark on this category comes from, and it is why the mark is accompanied by a four-digit number. Those four digits identify the notified body that carried out the assessment. A bare CE mark with no number does not match a Class IIb device.
The transition ran out during 2024. A product that never went through MDR cannot stay on the EU market in this category.
Turkey works on notification, and the wording matters
Turkish suppliers describe their paperwork in local terms, and the local terms do not map cleanly onto EU ones. Cosmetics in Turkey are covered by Law No. 5324. The manufacturer notifies the product to the Ministry of Health through the national product tracking system. Nothing is approved.
The Turkish authority, TITCK, has been explicit that writing approved by the Ministry on packaging is not acceptable, because notification does not carry the meaning of a permission, a licence or an approval. So when a supplier tells you a product is Ministry approved, what exists is a notification record.
That alone is not a reason to walk away. It is a reason to ask for the document itself and read what it actually says, because the document is what your own authority will look at, not the sentence in the brochure.
What to check before you order
- If a CE mark is shown, ask for the four-digit notified body number and the certificate behind it.
- Read the certificate scope. It should cover the product you are ordering, not a related family.
- Check which regulation the certificate names. Documents issued under the old Medical Devices Directive are not interchangeable with MDR certificates.
- If a lubricant is offered to you as a cosmetic for an EU market, ask how that is intended to work. Cosmetic status may hold in other jurisdictions, but inside the EU it puts your import at risk.
- Ask who the responsible person or authorised representative for your market is, and whether that role lands on you.
- Ask what your market requires on the label, in which languages, and who produces the artwork.
None of this is unusual to ask. A manufacturer used to export work will have answers ready, and the speed of the answer tells you something on its own.
Classification is per market, not per product
The same formulation can be a medical device in one market, a cosmetic in another, and something needing separate registration in a third. Gulf, North African, Russian and Latin American markets each run their own scheme, and the fact that a product is on sale in the EU says nothing about whether it can enter them.
The practical order of work is to fix the destination market first, then ask what that market requires, then ask the supplier to produce that specific set. Asking for all your certificates produces a folder that answers nobody in particular.
We do not publish our own regulatory position on this site, because the answer depends on the market a distributor is asking about and the document set is prepared for that market. Our quality page covers how we handle production and documentation, and current copies go out to applicants through the distribution form.
