The Era Of EU HTA Has Officially Begun—But How Will Medical Devices Be Affected?

By Mareike Konstanski, MSc, Kim Joline Schmidt, MSc, and Ruairi O'Donnell, PhD

The EU Health Technology Assessment Regulation (HTAR) began in January 2025, initially applying to oncology and advanced therapy medicinal products (ATMPs). By 2026, high-risk medical devices (MDs) and in vitro diagnostics (IVDs) will also require Joint Clinical Assessments (JCAs). These include Class IIb and III MDs and Class D IVDs that have undergone expert panel evaluation.

As of February 2025, five of six implementing acts have been adopted, with the JCA procedural act for MDs still pending. A key development is the Joint Scientific Consultation (JSC) process, allowing manufacturers to seek guidance on clinical data requirements. JSCs can occur in parallel with expert panel consultations, coordinated by the HTA secretariat and the European Medicines Agency (EMA).

Manufacturers must submit JSC requests during defined periods, with the first for MDs and IVDs occurring in June 2025. They can request meetings with assessors to refine their briefing packages. The consultation process involves regulators, clinical experts, and industry representatives, culminating in an outcome document with recommendations for EU Member States.

Pending procedural guidance documents are expected in early 2025, clarifying requirements for JSCs and JCAs. While gaps remain, the HTAR aims to streamline assessments and enhance regulatory alignment. Companies must prepare for upcoming changes to optimize market access pathways before JCAs become mandatory for MDs in 2026.