MDR Processes for Intimacy Products

We Support Manufacturers in MDR Processes for Intimacy Products

We Support Manufacturers in MDR Processes for Intimacy Products covers end-to-end regulatory, analytical, and technical support for medical devices intended for intimate use, in accordance with Medical Device Regulation (EU) 2017/745. Due to direct or prolonged contact with sensitive body areas, intimacy products require enhanced safety and compliance evaluations.

Therefore, We Support Manufacturers in MDR Processes for Intimacy Products represents a structured and technically robust compliance strategy rather than basic consultancy.

MDR Classification of Intimacy Products

Depending on intended use and contact duration, intimacy products are generally classified as:

• Class I

• Class IIa

We Support Manufacturers in MDR Processes for Intimacy Products ensures correct MDR classification and prevents regulatory misinterpretation.

Scope of MDR Support Services

Within the framework of We Support Manufacturers in MDR Processes for Intimacy Products, the following services are provided:

• MDR classification and scope assessment (Annex VIII)

• MDR Annex II & III technical documentation preparation

• Biocompatibility evaluation according to ISO 10993 series

• Chemical characterization and toxicological risk assessment

• Risk management per ISO 14971

• Clinical Evaluation Report (CER) in line with MDR Annex XIV

This integrated approach ensures full regulatory compliance and audit readiness.

Added Value for Manufacturers

• Streamlined MDR compliance process

• Reduced regulatory risks and delays

• Technically substantiated CE marking pathway

• One-stop management of testing and documentation

Thus, We Support Manufacturers in MDR Processes for Intimacy Products enables safe and efficient EU market access.