Tag Archive for: Regulatory

Using in vitro data for regulatory approval of medical devices according to MDR

Regulatory approval of medical devices according to MDR using in vitro data from GARDskin Medical Device for skin sensitization assessment


Presented at Eurotox 2023

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Conclusion

  • The GARDskin Medical Device assay is a novel method for assessment of skin sensitizing properties in leachables from solid materials, according to ISO 10993 standards.
  • Here, we demonstrate how GARDskin Medical Device data, combined with endpoint data from skin irritation and cytotoxicity testing, were successfully used in a data package for biocompatibility assessment of a novel medical device.
  • Following review by a notified body, an obtained CE-mark for the medical device Tinearity® G1 highlights unique opportunities to comply with the European Medical Device Regulation 2017/745 (MDR) using only in vitro data sources.

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Abstract

Skin sensitizers in medical device extracts are conventionally assessed in vivo, primarily using the Guinea Pig Maximization Test and the Buehler Occluded Patch Test. However, there is a shift in the medical device toxicology field towards an increased use of in vitro methods for the evaluation of the biological safety of medical devices. Recently, in vitro methods for the endpoints skin irritation and skin sensitization have been included in the ISO 10993 standard, what makes it possible to perform this testing in vitro. The GARDskin assay is one of the in vitro methods for assessment of skin sensitization described in ISO 10993-10 and is the first OECD TG 442 method that has been adapted to work with oil, the non-polar extraction vehicle often used in in vivo studies for testing medical devices.

Here we share an example of how in vitro testing results, including results from the GARDskin Medical Device assay, were submitted to obtain CE-marking according to the European Medical Device Regulation 2017/745 (MDR) for Tinearity® G1, an innovative tinnitus treatment medical device. Tinearity® G1 was classified as a non-sensitizer in both polar and non-polar extracts in the GARDskin Medical Device assay. This result was used together with in vitro cytotoxicity and in vitro skin irritation results as weight of evidence together with review of chemical data in the risk assessment and biological evaluation of the medical device.

Tag Archive for: Regulatory

SenzaGen webinars

Webinar: Advancing Medical Device Biocompatibility testing with NAMs

Regulatory updates, industry case studies, and newly published evidence for wearable devices

Can the “Big Three” be addressed using non-animal methods? Scientifically validated in vitro approaches are available to assess cytotoxicity, skin irritation and skin sensitization, supporting more predictive and human-relevant biocompatibility testing. As the regulatory landscape continues to evolve, medical device manufacturers face growing opportunities to incorporate these methods into biocompatibility assessments and regulatory submissions.

Join us for a webinar exploring the latest developments within the ISO 10993 framework and how New Approach Methodologies (NAMs) are being applied in practice. We are also pleased to welcome Florian Gerdts, Team Lead Process Development at Element 22, who will present a case study on metallic 3D-printing materials.

Through regulatory perspectives and industry case studies, our speakers will discuss how in vitro methods can support decision-making from early material screening to CE-marking submissions.

Just published: We will also present findings from a newly published peer-reviewed study on wearable devices, providing new evidence for the use of GARD® assays in assessing both constituents and finished-product leachables.

Build readiness
• Develop your NAM database
• Gain testing experience
• Strengthen weight-of-evidence assessments

The webinar will last around 45 minutes, followed by a live Q&A. If you cannot attend the live event, register anyway to receive the recording.

Key takeaways

  • Regulatory insights: Stay informed on the latest developments in ISO 10993-5, ISO 10993-23 and ISO 10993-10, and the growing role of in vitro methods.

  • GARD® advancements: Learn how GARD® supports both skin sensitization hazard and quantitative potency assessment of extractable medical devices and solid materials in polar and non-polar vehicles.

  • Industry application: Discover how NAMs are used as weight-of-evidence in CE-marking submissions, testing of 3D-printed oral devices, metallic 3D-printing materials, and early-stage material screening.

  • Featured publication: “Assessing the skin sensitizing potential of constituents and leachables from wearable devices using GARD®” by Persaud et al. (Apple, SenzaGen). Learn how the study applies GARD® assays to both wearable device constituents and finished-product leachables.

Speaker

Andy Forreryd, PhD
Scientific Liaison Manager @ SenzaGen

  • Co-developer of the GARD®skin assay (OECD TG 442E).
  • Member of the ISO/TC 194/WG 8 on irritation and sensitization.
  • Member of OECD expert group on respiratory sensitization.


Florian Gerdts
Team Lead Process Development @ Element 22 GmbH

  • Master of Materials Science and Engineering, CAU Kiel
  • Titanium Powder Metallurgy Expert
  • > 14 years of experience in Titanium Pulver Metallurgy.