ARTICLE SUMMARY:
In this week’s Pathways Picks: The first two devices have been recommended to undergo EU-side joint clinical assessments; six products have been chosen for Europe’s breakthrough device pilot; the slow transition to the MDR/IVDR continues; Shuren joins MedTech Innovator, and more personnel news; updates from Canada, Australia, and India; and more.
EU Picks
JCA selections, breakthrough designations, and transition updates:
Devices enter the EU HTA fray. Two implantable cardiovascular implants have been selected as the first medical devices that will undergo an EU-wide “joint clinical assessment” (JCA) process. The identity of the devices wasn’t publicized but manufacturers of all eligible devices are being notified whether a JCA was recommended for their device. The two devices were formally recommended for JCA by the EU Member State Coordination Group on HTA during a June 22 meeting in Brussels.
JCAs are mandatory EU-wide health technology assessments that are intended to inform, though not dictate, national market access and reimbursement decisions. Once selected devices receive a CE mark, the manufacturer must participate in a scoping phase and then submit a full evidence dossier to support a comparative effectiveness review. The JCA process was established last year by the Health Technology Assessment Regulation but up until now has only been applied to drugs. Only Class III devices, Class D IVDs, and some Class IIb devices that have been subjected to an expert panel review under the Medical Device and IVD Regulations (MDR and IVDR) are eligible. Among those, a smaller subset of devices that address an unmet need, are first in class, have a significant cross-border dimension, or meet other criteria will be prioritized. According to EU planning, up to five devices will undergo JCAs in 2026.
