MTRC has released a White Paper on Joint Clinical Assessment requirements for medical devices and IVDs

MTRC has released a new White Paper titled “Joint Clinical Assessment Requirements for Medical Devices and In-Vitro Diagnostic Medical Devices

The White Paper explains the requirements introduced by the EU Health Technology Assessment Regulation (EU) 2021/2282. It covers evidence identification and literature searches, study designs and clinical outcomes, patient-reported measures, risk-of-bias assessment, real-world evidence, direct and indirect evidence synthesis, and dossier reporting requirements.

Under the JCA framework, health technology developers must identify all relevant evidence, address each PICO included in the final assessment scope, apply appropriate analytical methods, and submit a dossier that is complete, transparent, and suitable for independent verification.

The publication is particularly relevant for medical device and IVD manufacturers, market access teams, clinical development and biostatistics functions, regulatory affairs professionals, evidence generation specialists, and senior decision-makers preparing for EU Joint Clinical Assessments.

Read more and request the White Paper here.