In Vitro Testing as an Alternative to In Vivo Biocompatibility Testing

Medical devices have become a crucial component of the health care system from diagnostics, to the prevention and treatment of diseases. Medical devices have to undergo testing to demonstrate that they meet regulatory requirements and to ensure they are safe and perform as intended.

Under the general necessity to advance the replacement, reduction and refinement of in vivo testing interest in in vitro testing alternatives to assess the safety of the devices is rapidly growing. According to ISO 10993-1 in vitro test methods which are appropriately validated, reasonably and practically available, reliable and reproducible shall be considered for use in preference to in vivo tests. There is also a growing recognition that in vitro testing of medical devices can be more effective, both in terms of cost and time, than in vivo testing.

Eurofins Medical Device Testing network of laboratories, actively committed to scientific advancement, has established a dedicated in vitro laboratory with the aim to develop safe and reliable in vitro alternative methods to support toxicological safety evaluations.

Our rigorous scientific expertise coupled with the highest level of instrument technology available in the industry makes us a key player in the advancement of alternatives to animal testing. Our GLP compliant facility with extensive technical capabilities allows us to perform standard testing services for customers as well as custom new alternative assays.

Eurofins Medical Device Testing network of laboratories can also support our clients to determine the optimum assay for specific test materials and applications.

Choose Eurofins Medical Device Testing to help you:

• Develop safe and reliable in vitro alternative methods to support toxicological safety evaluations
• Obtain highly reliable data to identify a toxic effect and to gain a valid knowledge of the product interaction with a reconstructed human tissue
• Perform standard and custom alternative assays

Full scope of services

• Cytotoxicity testing for medical devices, in compliance with ISO 10993-5 standard
• Eye irritation testing on 3D reconstructed corneal epithelium according to OECD 492
• Skin irritation testing on in vitro reconstructed epidermis according to OECD 439, OECD 431
• Skin corrosion testing according to OECD 431
• Percutaneous absorption following OECD TG 428 criteria
• Skin sensitization testing (RHE IL-18 assay)

In vitro biocompatibility testing
Our in vitro testing services provide valid and reliable data to identify a toxic effect and to gain a sound knowledge of the product interaction with a reconstructed human tissue.

Quantitative evidence on all classes of medical devices is provided:

• Absence of toxic effects due to product or auxiliary substance
• Absence of systemic effects related to substance penetration according to the medical devices classification criteria
• Absence of interference with the tissue physiological equilibrum

Figure 1: In vitro biocompatibility testing approach

Our areas of expertise

Toxicity studies:

• Skin irritation and corrosion according to OECD 439, OECD 431
• Eye irritation according to OECD 492
• Skin sensitization according to RHE IL-18 assay

Biocompatibility studies:

• Cytotoxicity and irritation potential evaluation of medical devices (Class I, IIa, IIb and III) on:
  • Epidermis, Epithelia (oral, gingival, corneal, nasal, colon, vaginal) models.

Pharmacokinetics/toxicokinetics and ADME studies:

• Skin absorption - in vitro method (OECD TG 428) studies on:
  • Reconstructed 3D tissue Models: RHE, and Epithelial models
  • Reconstructed 3D tissue Models with impaired barrier function.

Figure 2: Parameters addressed from our approach