Medical Device Qualification.

Does your substance-based product qualify as a Medical Device?

Determining whether your product qualifies as a Medical Device can be challenging. Under the EU MDR, manufacturers must provide scientific evidence that their product’s principal Mode of Action (MoA) is not Pharmacological, Immunological, or Metabolic to meet the criteria for a Medical Device.

Demonstrating Mode of Action for MDR compliance

1. Literature review and pharmacological assessment

Our experts conduct an in-depth literature review to evaluate the functional ingredients in your product. In many cases, a thorough literature review provides sufficient scientific evidence to qualify your product as a Medical Device.

2. Determining the need for additional testing

If existing data is sufficient, a pharmacological risk assessment report is prepared. If further data is required, we can proceed with customized in vitro testing to further demonstrate the product’s MoA.

3. In vitro testing on 3D models to demonstrate the MoA

When additional evidence is required, we utilize 3D reconstructed human tissue models to perform tailored in vitro testing. Our protocols are designed to demonstrate or exclude specific MoA.

Key therapeutic areas include:

  • Dermatology
  • Gastroenterology
  • Gynaecology
  • Ophthalmology, and more
Read more about the customized protocols.
4. Expert report

Based on the test results, our experts provide a detailed evaluation, drawing conclusions on the product’s primary MoA. This analysis supports your product’s qualification as a Medical Device and ensures alignment with regulatory requirements.

Relevant standards:

  • Regulation (EU) 2017/745 of the European Parliament and the Council of 05 April 2017 on medical devices (MDR)
  • MDCG 2021-24 Guidance on classification of medical devices

Get expert support for your testing and regulatory needs

We offer comprehensive testing services and expert guidance to help you navigate the regulatory landscape.

From planning and documentation to interpreting test results, reporting, and communicating with Notified Bodies, we’re here to support you every step of the way.

  • Support the identification and qualification of both new and existing Medical Devices under the MDR.
  • Expert advisory services to help interpret study results, ensuring informed decisions regarding regulatory compliance and product development.

Services provided by SenzaGen Group companies VitroScreen and ToxHub. The VitroScreen in-vitro laboratory is ISO 9001 and ISO 13485 certified.