Menstrual Cup FDA & CE Certification Guide for Private Label Brands

For a private label menstrual cup project, regulatory and documentation requirements should be reviewed before product claims, packaging artwork and production decisions are finalized. This guide provides a practical overview of the questions brands should ask about the US and EU markets, product documentation and manufacturer coordination. Requirements vary by product and destination, so confirm them with qualified regulatory advisors and the relevant authorities. You can also review our feminine-care manufacturing scope or contact the OEM team with your project brief.

The good news: the process is manageable, and a factory with existing regulatory experience can dramatically reduce your cost and timeline. Here is everything you need to know.

In the United States, menstrual cups are classified as Class II medical devices under 21 CFR 884.5900. To sell a menstrual cup commercially in the US under your brand, you must obtain FDA 510(k) clearance — which establishes that your product is “substantially equivalent” to a legally marketed predicate device.

• Device description: Full technical specifications of your menstrual cup (dimensions, materials, silicone grade, Shore hardness, capacity)
• Predicate device comparison: Identification of an FDA-cleared menstrual cup you are substantially equivalent to
• ISO 10993 biocompatibility data: Full test reports for cytotoxicity, sensitization, and systemic toxicity
• Performance testing: Leakage testing, insertion/removal force data, capacity data
• Labeling: Draft labeling compliant with 21 CFR 801 requirements
• Manufacturing information: FDA-registered facility details

In the European Union, menstrual cups are classified as Class IIa medical devices under the Medical Device Regulation (MDR) 2017/745. CE marking is mandatory for sale in any EU member state, as well as in the UK (UKCA marking), Norway, Iceland, and Switzerland.

• Notified Body involvement: Class IIa devices require conformity assessment by an EU Notified Body (e.g., BSI, TÜV SÜD, SGS)
• Technical documentation: Device description, risk management file (ISO 14971), clinical evaluation report, performance data
• EU Authorized Representative: Non-EU manufacturers must appoint an EU-based AR
• Eudamed registration: Device and economic operator registration in the EU database
• Post-market surveillance: Ongoing vigilance and reporting obligations

The right manufacturing partner can significantly reduce the cost and complexity of your regulatory submission. Here is what to expect from a factory with medical device experience:

• Existing test reports: ISO 10993 biocompatibility data for their silicone formulation (reduces your testing cost if you use their standard material)
• Technical file templates: Pre-built device description documents, material spec sheets, and risk management frameworks
• FDA-registered facility: Eliminates the need for you to register a separate manufacturing location
• ISO 13485 quality system: Required by both FDA and EU MDR; the factory’s certification covers your product
• Referrals to regulatory consultants: Experienced factories maintain relationships with consultants specializing in FDA and CE submissions for this product category

Menstrual Cup Certification FAQ

What information should a brand prepare before discussing certification?

Prepare the target market, product dimensions, materials, intended use, packaging, proposed claims and any available test or technical documents. This helps the manufacturer and qualified regulatory advisers review the project consistently.

Is FDA clearance the same as CE marking?

No. They relate to different markets and regulatory frameworks. The applicable pathway depends on the exact product, intended use and destination, so the responsible brand should obtain market-specific advice before making a claim.

Can an OEM manufacturer provide regulatory documents?

A manufacturer may be able to provide available product, material, quality and testing documents for project qualification. The availability and scope of each document must be confirmed for the exact product, manufacturing entity and destination market.

Can a brand copy a general FDA or CE claim onto its packaging?

No general claim should be copied without verification. Confirm that the document applies to the exact product, configuration, responsible entity and target market before using it in artwork, advertising or sales materials.

What should I include in an OEM quotation request?

Include the target country, product material, sizes, packaging, intended claims, requested tests or documents and estimated quantity. Contact the OEM team if you need help organizing the project brief.