Products · Medical devices
Intimate health: vaginal gels, moisturising gels, ovules
Medical devices for intimate health under EU MDR: vaginal gels, moisturising and hydration gels, ovules and vaginal suppositories — development, technical documentation and legal manufacturing.
INOPREX is a development and manufacturing partner for medical devices in intimate health: vaginal gels, moisturising and hydration gels, ovules and vaginal suppositories. Classification follows EU MDR; class IIb is typical because substances act locally on the vaginal mucosa without systemic absorption. Formulation, claims and directions are designed to avoid disease-related statements. For medical devices, INOPREX acts as the legal manufacturer.
Product portfolio
- Vaginal gels (e.g. with hyaluronic acid)
- Moisturising and hydration gels
- Ovules (hard and soft forms)
- Vaginal suppositories
- pH-supporting gels
Regulatory classification
EU MDR — Regulation (EU) 2017/745, rule 21 (substance-based devices applied at body orifices without systemic absorption): regularly class IIb. Purely caring intimate products are cosmetics under Regulation (EC) No 1223/2009.
INOPREX develops, manufactures and takes on regulatory responsibility — in the role that fits your project. For medical devices we act as the legal manufacturer under EU MDR. For cosmetics and food supplements we either take on the role of the responsible person or the person placing the product on the market, or we manage development and production while your brand remains the market operator. Production runs together with leading contract manufacturers and fillers in the EU. White label uses established, documented formulations (MOQ from 10,000 units per SKU); private label develops an exclusive formulation to your briefing (MOQ project-dependent).
Frequently asked questions
What is the difference from cosmetic intimate care?
Cosmetic intimate care (e.g. washes) falls under Regulation (EC) No 1223/2009 and cleanses or cares. A medical device has a medical purpose — e.g. supporting physiology — and goes through MDR conformity assessment. We cover both routes and recommend the classification upfront.
Which claims are permitted?
Medical devices carry no promises of cure and no disease-related advertising. We formulate permissible, product-specifically substantiated statements and document them in the technical documentation.
What MOQ applies?
White label from 10,000 units per SKU where established formulations can be used; private label project-dependent.
Request your project
Send us your product idea, dosage form and target market via the contact form — we will respond within two working days with an initial assessment.