EU Authorized Representative for Condom Manufacturers: Rule 15, Class IIb and Notified Body Review
A condom is never a class I device under Regulation (EU) 2017/745. Rule 15 of Annex VIII places every device used for contraception or prevention of sexually transmitted diseases in class IIb, and a condom with spermicide moves to class III under Rule 14. Both require a notified body. For a manufacturer established outside the Union, Article 11 adds a further condition: a sole authorised representative must be designated before the first condom is placed on the Union market.
Why a condom is a medical device
The MDR definition of a medical device lists medical purposes, including prevention of disease, and then names a category that is deemed to be a medical device whatever the other purposes:
"The following products shall also be deemed to be medical devices: — devices for the control or support of conception;" (MDR Article 2(1))
A condom intended for contraception is therefore a device by definition, and a condom intended to prevent the transmission of sexually transmitted infections is a device through the prevention limb of the same article. MDCG 2021-24 Rev.1 notes that condoms have a dual function and serve both purposes at once.
Rule 15: the rule that sets the class
On the invasiveness rules alone, a condom would look like a low-risk product. It is used in a body orifice for less than 60 minutes, which under Rule 5 would point to class I. Annex VIII does not stop there:
"3.5. If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device's intended purpose, the strictest rule and sub-rule resulting in the higher classification shall apply." (MDR Annex VIII, Section 3.5)
The strictest rule is Rule 15:
"Rule 15 All devices used for contraception or prevention of the transmission of sexually transmitted diseases are classified as class IIb, unless they are implantable or long term invasive devices, in which case they are classified as class III." (MDR Annex VIII, Rule 15)
MDCG 2021-24 Rev.1 explains that the rule is not limited to devices based on physical barriers, and gives "Condoms and femidoms (internal condoms)" as its first class IIb examples. The class III branch is intended for implantable or long-term devices such as tubal ligation clips and non-hormonal intrauterine devices; a condom does not reach it by duration.
A condom does reach class III through its composition. When a spermicide is incorporated, Rule 14 applies:
"Rule 14 All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III." (MDR Annex VIII, Rule 14)
MDCG 2021-24 Rev.1 lists "Condoms with spermicide" as a Rule 14 example.
Product variants and their class
| Product | Rule relied on | Class | Notified body |
|---|---|---|---|
| Natural rubber latex male condom, with or without silicone lubricant | Rule 15 | IIb | Yes |
| Synthetic male condom (polyurethane, polyisoprene or other non-latex material) | Rule 15 | IIb | Yes |
| Internal (female) condom | Rule 15 | IIb | Yes |
| Textured, flavoured, coloured or extra-thin variant sold as a condom | Rule 15 | IIb | Yes |
| Condom with spermicide incorporated as an integral part | Rule 14 (prevails over Rule 15) | III | Yes, with medicinal products authority consultation |
| Condom with an incorporated substance that would be a medicinal product if used separately, such as a local anaesthetic, where its action is ancillary | Rule 14 | III | Yes, with medicinal products authority consultation |
| Dental dam intended to prevent STI transmission | Rule 15 | IIb | Yes |
| Personal lubricant supplied as a separate product | Classified in its own right | Depends on composition and claims | Depends on class |
Material, lubricant and variant changes do not lower the class. They do matter for the technical documentation and for the device registration in EUDAMED, because a new material or incorporated substance is a different device, not a size variant.
Conformity assessment and standards
For a class IIb condom, the conformity assessment route is set by Article 52(4):
"4. Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group." (MDR Article 52(4))
In practice this means a certified quality management system with notified body surveillance, plus a technical documentation assessment on a sampling basis. For a spermicidal condom, Section 5.2 of Annex IX requires the notified body to seek a scientific opinion from a medicines authority or the EMA on the quality and safety of the substance before it issues the certificate.
Manufacturers should check which standards give a presumption of conformity. The Commission's summary list of harmonised standards cited under Regulation (EU) 2017/745, generated on 17 June 2026, does not include a condom-specific product standard. Horizontal standards on that list, such as EN ISO 13485:2016 for quality management, EN ISO 14971:2019 for risk management, EN ISO 10993-1:2025 for biological evaluation and EN ISO 15223-1:2021 for symbols, do give a presumption for the aspects they cover. Burst properties, freedom from holes, dimensions and shelf life must be demonstrated against the state of the art in the technical documentation, and the notified body will review how the manufacturer has justified the methods it applied.
Pitfalls around claims and responsibility
Claims are part of the intended purpose. Statements such as "protects against HIV" or "extra safe" must be supported by the clinical evaluation. Article 7 prohibits labelling and advertising that ascribe to a device functions or properties it does not have.
Clinical evaluation is required at class IIb. Article 61 applies to every class. For condoms, the clinical evaluation typically rests on published data and post-market experience, and it must be kept current through post-market clinical follow-up.
Private-label supply shifts obligations. Under Article 16(1)(a), a distributor or importer that places condoms on the market under its own name or trade mark takes on the manufacturer's obligations, unless the actual manufacturer is identified on the label and remains responsible. A non-EU brand owner who contracts production out is the legal manufacturer and needs its own authorised representative.
The certificate must cover every variant sold. A new material or an added substance falls outside an existing certificate until the notified body has assessed it.
What Medex does under the mandate
Article 11(1) applies to condoms exactly as it applies to any other device:
"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))
Medex Kurumsal Danışmanlık acts as authorised representative under EUDAMED SRN TR-AR-000057550. Under the mandate we verify that the EU declaration of conformity, technical documentation and notified body certificate are in place and match the variants you sell, keep copies at the disposal of competent authorities, complete our own actor registration and check your UDI and device registrations, forward authority requests for samples or documents, cooperate on corrective actions, and pass on incident reports without delay. A person responsible for regulatory compliance is available in-house, as Article 15(6) requires.
The European Commission's Notice of March 2022 confirms that manufacturers outside the EU and Türkiye "only need to designate one authorised representative, either in the EU or in Turkey", so one Medex mandate covers both markets. Offices in Ankara, İstanbul and Gdańsk.
Annual fees range from €800 for class I to €2,000 for class III, with a €0 setup fee and €150 for a change of representative. We do not write technical documentation or clinical evaluations, we are not a notified body, and we do not find distributors or act as a Swiss or UK representative. We reply within one business day.
Related device categories and country pages
We keep separate pages for other device groups, including examination and surgical gloves, dermal fillers and IVD reagents and test kits. All groups are listed on the medical device categories page. Most of the manufacturers we represent are based in China, Türkiye, India and South Korea; the full list is on the EU authorized representative by country page.
To check how Annex VIII applies to your own device, use our free MDR classification checker. It walks through rules 1 to 22 and quotes the rule text behind every result.
If your device is still placed on the market under an MDD, AIMDD or IVDD certificate or declaration, the free MDR and IVDR transition deadline checker shows the Article 120 or Article 110 date that applies and the conditions it depends on.
Frequently asked questions
Can a condom be self-certified as a class I device?
No. Rule 15 classifies every device used for contraception or prevention of sexually transmitted diseases as class IIb, and Section 3.5 of Annex VIII requires the strictest applicable rule. A notified body must be involved.
Our condoms contain spermicide. What changes?
The product becomes class III under Rule 14, and before issuing the certificate the notified body must obtain a scientific opinion from a medicines authority or the EMA on the substance, under Section 5.2 of Annex IX.
Is there a harmonised standard for condoms under the MDR?
The Commission's summary list generated on 17 June 2026 does not cite a condom-specific standard under Regulation (EU) 2017/745. Horizontal standards such as EN ISO 13485:2016 and EN ISO 14971:2019 are cited; product performance must be justified in the technical documentation.
Do we need a separate representative for Türkiye?
No. Under the EU–Türkiye Customs Union arrangement described in the Commission Notice of March 2022, one authorised representative, established in the EU or in Türkiye, covers both.
Sources
Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu
MDCG 2021-24 Rev.1, Guidance on classification of medical devices (April 2026) — health.ec.europa.eu
European Commission, Harmonised standards for medical devices — single-market-economy.ec.europa.eu
European Commission, Summary list of harmonised standards (Regulation (EU) 2017/745) — single-market-economy.ec.europa.eu
European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu
Get a fixed-price EU REP quote for your condom range (reply within 1 business day).