Choosing the Right Testing Methods

MDR Compliance Choosing the Right Testing Methods

2024-07-11 From Elina Tenhunen and Laura Ahola, Testing Experts at Measurlabs 4 min Reading Time

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Finnish laboratory service provider Measurlabs guides manufacturers through MDR compliance regarding E&L testing strategies, helping with the selection of testing conditions and analytical methods to ensure they match the device and its intended use.

Once extraction has been performed, the extracts are analyzed using sensitive and selective methods that are capable of detecting analytes in quantities consistent with the AET. (Source: bung - stock.adobe.com) — Once extraction has been performed, the extracts are analyzed using sensitive and selective methods that are capable of detecting analytes in quantities consistent with the AET.
(Source: bung - stock.adobe.com)

Characterization of extractables and leachables (E&L) by ISO 10993-18 is one of the first medical device biocompatibility assessment steps and is generally required for all new devices to ensure compliance with the EU Medical Device Regulation (MDR). Knowing where to start can be difficult, however, as the diversity of medical device materials complicates the process of selecting the most appropriate E&L testing methods and conditions.

MDR requirements for extractables and leachables testing

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