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MedTech Europe Urges Tailored Approach to Validating Biomarker Assays

Posted 06 March 2019 | By Ana Mulero 

MedTech Europe Urges Tailored Approach to Validating Biomarker Assays

MedTech Europe issued a discussion paper to propose a fit-for-purpose approach for the validation of biomarker assays used in early clinical trials, offering three new guiding principles.

The 8-page discussion paper takes issue with a trend among some competent authorities seeking to mandate CE marking on predictive biomarker assays prior to being used in clinical trials. It asserts that industry agrees with “overarching safety goals” that assays should be appropriately validated for clinical research use, but with a fit-for-purpose regulatory pathway rather than required CE marks on all assays.

The European trade association noted that the regulation of companion diagnostics “is a relatively new field,” with the first definition of the term set forth in 2017 as part of the EU’s new in vitro diagnostic regulation (IVDR). Regulators face certain challenges in efforts to harness the known potential of predictive biomarker assays in personalized medicine as assays present unique issues compared to the regulation of medical devices. This partly explains the EU’s move for a regulatory overhaul via IVDR in combination with its sister regulation on medical devices (MDR), which is set for 26 May 2020.

The new guiding principles are intended to address industry concerns regarding the press for CE marking in the context of the current IVD Directive, which will continue to apply until 26 May 2022. The principles relate to clearly identifying the intended purpose of the assay component early in a drug-device co-development process, as well as making determinations on risk and the appropriate regulatory pathway based on the intended purpose of the assay within the specific context of its use in clinical research.

“CE-marking means a time delay of several months if not more, beyond the time necessary to follow the procedure for a device performance evaluation,” MedTech Europe argued. “This leads to delay in clinical trial initiation which in turn could delay the availability of medicinal products to clinical trial subjects (during the trial) and once in the routine healthcare system (to patients).” The IVD Directive states that a device intended for performance evaluation should not be CE marked but can be placed on the market once CE-marked. These pathways “are in direct contradiction to each other,” the group further argued.  

The group hopes that the discussion paper will help guide discussions with and provide clarity to regulators on appropriate approaches to the regulation of assays, including predictive biomarker assays.

To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.


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