Plasters Vs Period Products
If plasters are Class I medical devices in the EU, why shouldn't tampons be held to the same quality and biocompatibility standards?
It's a question that seems obvious once you think about it. A plaster sits on your skin for a few hours. A tampon is inserted into one of the most absorbent mucosal tissues in the body, often for 4-8 hours at a time, repeatedly, for decades of a person's life.
Yet in the EU, menstrual products—including cups, pads, and tampons—are classified as hygiene products under the General Product Safety Regulation (GPSR), not medical devices. Unless, that is, manufacturers choose to voluntarily market them as medical devices.
Under the Medical Device Regulation (MDR), manufacturers can voluntarily classify their menstrual products as medical devices by applying Rule 4:
Class I, if non-invasive medical devices act as a mechanical barrier for absorption and come into contact with a mucous membrane
Class IIa, if controlling the micro-environment of the mucous membrane or diagnostic
This voluntary pathway exists—but very few manufacturers take it. And here's why that matters.
What's the Difference?
The gap between a hygiene product and a Class I medical device isn't just bureaucratic classification. It's a fundamental difference in accountability and safety standards:
Product Design & Testing
Hygiene product: Basic safety assessments under GPSR
Class I medical device: Thorough documentation and biocompatibility testing for cytotoxicity, irritation, sensitization, and leachables per ISO 10993
Legal Paper Trail
Hygiene product: Non-standardised quality systems
Class I medical device: Mandatory ISO 13485 Quality Management System with full traceability from raw materials to finished product
Production Environment
Hygiene product: "Clean" room (undefined standards)
Class I medical device: Certified cleanroom with documented environmental controls
Surveillance
Hygiene product: Reactive response to complaints
Class I medical device: Proactive post-market surveillance, vigilance reporting, and periodic safety updates
These aren't trivial differences. They're the scaffolding that ensures product safety when something is inserted into your body thousands of times over your lifetime.
US Takes a Different Approach
Here's where it gets interesting: in the United States, menstrual products are regulated as medical devices by the FDA:
Pads: Class I medical devices
Tampons and cups: Class II medical devices (requiring 510(k) premarket notification)
This means, in principle, a higher baseline for quality and safety of menstrual products in the US compared to the EU.
But—and this is important—there are two contrasting factors that complicate this picture:
Factor 1: The Predicate Problem
FDA clearance for Class II devices relies on proving "substantial equivalence" to a pre-existing product (the predicate). For menstrual products, many of these predicates are decades old, with correspondingly low benchmarks.
The 510(k) pathway asks: "Is your product substantially equivalent to this 1980s tampon?" Not: "Does your product meet 2025 safety standards?"
This creates a regulatory floor that hasn't risen substantially in 40+ years. Manufacturers must demonstrate biocompatibility and safety testing, but the comparison point is historical, not state-of-the-art.
Factor 2: EU's Horizontal Chemical Legislation
The EU has stronger horizontal legislation than the US, with general bans on:
Carcinogens, mutagens, and reprotoxic (CMR) substances
Endocrine disruptors
Certain phthalates and parabens
Specific pesticide residues
These bans apply to all consumer products, including hygiene products, through REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and the General Product Safety Regulation.
The new GPSR (which fully applied from December 2024) strengthens these protections:
Mandatory risk assessments before market placement
Technical documentation of hazards and mitigation
Designated EU responsible person
Enhanced traceability (batch coding for rapid recalls)
Proactive approach to safety, not just reactive
Additionally, the EU Ecolabel criteria (updated September 2023) ban many hazardous substances from certified products:
Antibacterial agents
Formaldehyde
Parabens
Endocrine disruptors
Phthalates
Allergenic fragrances
So while EU menstrual products aren't medical devices, they benefit from chemical safety requirements that make even hygiene products safer than some US medical devices might be, depending on their predicate.
The voluntary approach: Daye’s case
This is where companies like Daye become important. Founded and led by Valentina Milanova, Daye chose to produce tampons to medical device standards—even though they're not legally required to in the EU.
What does this mean practically?
Cleanroom production: Daye manufactures tampons in an ISO 14644-1 Class 7 cleanroom, the same standard required for medical device production. This isn't just marketing—it's certified, monitored environmental control.
ISO 13485 QMS: Full quality management system compliance, ensuring operations from production to testing to post-market surveillance match medical device requirements. When Daye identifies an issue with a tampon, they can trace every raw material that went into it and check other batches.
Gamma ray sterilization: Medical-grade sterilization to eliminate microbial contamination, reducing TSS (Toxic Shock Syndrome) risk.
Biocompatibility testing: Testing for cytotoxicity, irritation, sensitization—the full ISO 10993 battery that medical devices require.
Batch testing: Testing for pesticides, dioxins, heavy metals, CBD content (for their CBD tampons), THC content.
Full ingredient transparency: Voluntarily disclosing all ingredients and manufacturing processes, even though GPSR doesn't require it.
The result? Products manufactured to the same standard as stents and hip replacements—for something you insert vaginally multiple times per month for 30+ years of your life.
The Daye Warning Letter: A Cautionary Tale
In December 2024, the FDA issued a warning letter to Daye regarding their CBD-infused tampons. The letter highlighted a critical regulatory challenge: Daye's tampons were cleared under K223883 with indications "to absorb menstrual discharge," but their labeling and promotion suggested the device was "intended for relief of period related pain"—a major change in intended use requiring separate clearance.
This illustrates the complexity manufacturers face when trying to innovate in this space. Daye was attempting to address a real medical need (90% of menstruating people experience dysmenorrhea), but doing so triggered different regulatory requirements.
This tension between innovation and regulation is exactly why clear, appropriate frameworks matter.
Why This Matters for Women's Health
The average person who menstruates will use 11,000-17,000 tampons or pads in their lifetime. That's decades of exposure to whatever materials, chemicals, and contaminants are in those products.
Recent research has raised concerns:
A 2024 UC Berkeley study found heavy metals (lead, arsenic, cadmium) in multiple tampon brands
2023 studies detected PFAS ("forever chemicals") in menstrual products, even those marketed as PFAS-free
Vaginal and vulvar tissues absorb chemicals more rapidly than skin
Yet in the EU, manufacturers aren't required to:
Disclose ingredients on packaging
Test for specific contaminants beyond what GPSR mandates
Follow medical device biocompatibility protocols
Maintain cleanroom production environments
Conduct proactive post-market surveillance
The US requires slightly more (TSS warnings, tampon absorbency labeling) but doesn't mandate ingredient disclosure either, and the FDA only recommends (not requires) testing for pesticides, herbicides, dioxin, and specific pollutants.
The Bottom Line
Irrespective of regulatory stance, what matters is that menstrual products are produced safely and responsibly.
Kudos to Daye, Valentina Milanova, and Lisa Rodwell (ex-CEO) for pushing a whole sector towards higher standards. When a company voluntarily adopts medical device manufacturing standards for products not legally required to meet them, it demonstrates what's possible.
But we shouldn't rely on voluntary adoption. When a product is inserted into highly absorbent mucosal membranes for hours at a time, thousands of times over decades—shouldn't that merit the same regulatory rigor as a plaster on your skin?
The EU's chemical safety legislation provides strong horizontal protection. The US's medical device classification provides structural accountability. Both could learn from each other.
And both could learn from companies like Daye: when you manufacture for the body you actually have—not the regulatory minimum—everyone who menstruates benefits.
References
Linkedin Post: Daye’s cleanroom facility
Methodology Note: This article is based on my original LinkedIn post, reflecting my professional experience in femtech regulation and research into EU and US menstrual product regulatory frameworks. Claude AI assisted in elaborating the post into an article by integrating personal notes, literature research, fact-checking and further insights on the topic. All analysis and regulatory perspectives are my own, and all content has been reviewed by me for accuracy.
