Medical
devices

Substance-based medical devices: From toxicological testing to clinical follow-up

 

MDR-compliant solutions for your market authorization and post-market requirements

Your challenge: Substance-based medical devices under MDR 2017/745
Substance-based medical devices with controlled release or targeted elimination of bioactive substances have special requirements for demonstrating safety and performance. MDR 2017/745 requires comprehensive clinical evidence – both before market authorization and throughout the entire product life cycle.

Our solutions for substance-based medical devices:
Toxicological testing (in vitro) – risk classes I to IIb
Suitable test methods for medical devices can only be determined individually in order to do justice to the product and its intended use. Thanks to our extensive knowledge of in vitro methods, we can always find a meaningful test method for your specific requirements.

Special expertise in

• controlled release systems – proof of safe dosing over the duration of use
• targeted elimination – evaluation of degradation and excretion behavior
• existing products – closing evidence gaps for existing products

PMCF studies (Post-Market Clinical Follow-up)
Clinical follow-up is mandatory under the MDR and must ensure that data on quality, performance and safety are actively collected and analyzed throughout the product life cycle.

When you need PMCF studies:
To close evidence gaps for existing products
For continuous monitoring of product safety after market launch
For substance-based medical devices with new release mechanisms

From preclinical testing to post-market surveillance – we support you.