Directive Background
Israel's Ministry of Health issued Circular MD-2026-14 following a review of clinical performance study quality submitted in support of Class C IVD registrations over the 2023–2025 period. The review identified inconsistencies in laboratory quality management standards applied across studies conducted in Israel and internationally, leading to the decision to mandate ISO 15189:2022 alignment as a condition of study acceptability.
ISO 15189:2022 Key Changes Relevant to IVD Registration
ISO 15189:2022 introduced significant revisions to the 2012 edition in three areas relevant to clinical performance studies: expanded requirements for measurement uncertainty documentation, new provisions for point-of-care testing quality management, and strengthened requirements for method validation and verification records. Studies conducted under the 2012 edition that predate the circular's effective date of 01 October 2026 will continue to be accepted until 31 March 2027.
Impact on Overseas Studies
Manufacturers relying on clinical performance studies conducted outside Israel must confirm in their registration dossier that the reference laboratory held ISO 15189:2022 accreditation (or equivalent national accreditation body recognition) at the time of study conduct. Studies from laboratories accredited under CAP or equivalent international programmes will be accepted subject to a documented equivalence statement.
MOH Technical Support
Israel MOH's Medical Technology and Infrastructure Division will offer pre-submission meetings for manufacturers with questions regarding study design under the updated requirement. A guidance FAQ document will be published by 01 September 2026 on the MOH medical devices registration portal.