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Special considerations for conducting clinical performance studies for companion diagnostics under the European IVDD and IVDR

A look at the ISO 20916 standard for IVD device clinical performance studies

Part One of our series on IVD clinical and performance evaluation studies covers key differences between European IVDD and IVDR requirements

May 26, 2021 has arrived and the European Union’s Medical Devices Regulation (MDR) now governs medical devices (including active implantable medical devices or AIMDs). This roundup provides updates on recent resources made available by the European Commission to assist in MDR compliance.

European Medical Device Coordination Group (MDCG) addresses MDR clinical investigation requirements ahead of Date of Application

New Coordinated Assessment Pathway to expedite medical device clinical trial reviews in the UK

Following Brexit, medical device and IVD clinical study sponsors will face different sets of requirements in the EU and UK

Besides MDR and IVDR, additional European national laws as well as Good Clinical Practice (GCP) requirements must be followed for medical device and IVD clinical data

Recommendations for meeting "sufficient clinical evidence" requirements as part of European MDR compliance

How clinical trial monitoring can ensure reliable clinical evidence for medical device manufacturers

How senior management can support RA/QA staff meet new clinical data requirements under the European Medical Devices Regulation

Improvements to informed consent forms (ICF) recommended for US FDA Investigational Device Exemption (IDE) applications

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR requirements will increase the need for clinical studies; Proper investigator and investigation site selection is essential for successful studies; PMCF study sponsors and investigators should not underestimate requirements and obligations; In-person facility inspections and personnel interviews should be conducted to mitigate risks and determine proper clinical study support.

EMERGO BY UL SUMMARY OF KEY POINTS: European MDR clinical data requirements may impact up-classified medical devices as well as recertification of some devices. Manufacturers with CE Marked devices should be preparing post-market clinical follow-up (PMCF) studies now in order to comply with MDR requirements in 2020. Meeting the MDR’s PMCF requirements may impact some manufactures’ budgets in unforeseen ways.

EMERGO BY UL SUMMARY OF KEY POINTS: Good Clinical Practice (GCP) must be adhered to by medical device companies conducting clinical investigations for their products. GCP requirements make exceptions for software as a medical device (SaMD) for which some developers may qualify. Besides GCP, additional standards such as ISO 14155 may apply to clinical studies for medical devices.