EU MDR Transition and Israel Alignment for Medical Device Registrations

1. Key takeaways

The European Union extended the validity of certain approvals issued under the old directives through Regulation (EU) 2023/607 (March 2023), providing a transition period for MDR conversion; the corresponding instrument on the IVD side is Regulation (EU) 2022/112. The Medical Devices Division of the Israeli Ministry of Health issued an alignment document on 15 April 2024, permitting Israeli registrations to be processed on the basis of such extended European approvals under specific conditions. The four hard conditions are: conformity with the requirements of the old European directives, no significant change to the device or its intended use, a quality management system implemented before May 2024, and a signed contract with a notified body before September 2024. These conditions were drawn deliberately narrowly: the alignment document accepts the European transition as a source of valid technical evidence, but only for manufacturers who were already demonstrably on the path to MDR conversion when the window was defined.

2. Legal basis

The table below lists the European transition instruments, the Israeli alignment document and the related Israeli provisions capping registration validity.

3. Expert insights

The essence of this alignment arrangement is that Israel follows the European transition period rather than creating a separate set of rules. This fits the internal logic of the reliance mechanism: since the technical judgement comes from Europe, the European transition arrangements should be recognised as well. There is no independent Israeli re-evaluation hiding behind the alignment document, and no additional Israeli-specific evidence is required beyond the conditions listed above. For manufacturers, this is good news: the burden of proof sits where the technical judgement already sits, in Europe, provided the four hard conditions can each be evidenced from existing records rather than reconstructed after the fact. Where a condition cannot be evidenced, the honest conclusion is that the route does not apply, and the submission should be planned on the standard route instead of risking a rejection that consumes time and goodwill.

Of the four hard conditions, the last two are verifiable point-in-time conditions and are the most binding on companies:

Condition three: a quality management system implemented before May 2024. This is not a commitment to establish a system but a requirement that one is already implemented. Companies must be able to produce evidence of the system in operation (procedure documents, internal audit records, management review records). A QMS that exists only on paper or that was certified after the cut-off does not satisfy the condition.

Condition four: a signed contract with a notified body before September 2024. The contract is objective evidence and cannot be signed retrospectively. For companies without a signed contract, the registration route based on extended certificates does not apply, regardless of how strong their other documentation is.

Both points in time have now passed, which means the alignment window is closed: products meeting the conditions could use it within the window, while companies entering afterwards must either have completed MDR conversion or proceed through the standard route. GRZAN’s judgement is that companies holding legacy MDD certificates should complete MDR conversion as quickly as possible rather than relying on the cross-border availability of transition-period assets.

One further practical note: the validity of an Israeli registration is capped by the reference-country approval (Section 12(2) of the Regulations). The expiry date of an extended CE certificate therefore directly determines the expiry date of the Israeli registration. Companies must enter the actual expiry date of the European certificate, including any extension, accurately into their Israeli scheduling tables, since a mismatch here surfaces only at renewal.

4. Practical recommendations

• Verify satisfaction of the four hard conditions: keep evidence item by item and determine whether the alignment arrangement applies.
• Schedule by the extended expiry date: enter the post-extension expiry date of the CE certificate into the Israeli renewal dashboard.
• Accelerate MDR/IVDR conversion: the window in which transition-period assets can be used in Israel is limited; conversion is the long-term solution.
• Retain European extension letters: extension confirmations issued by the notified body or competent authority should be archived together, as supporting material for Israeli submissions.

5. Verification checklist

• □ Whether the CE certificate relied on falls within the extension scope of (EU) 2023/607 (or 2022/112 for IVDs) is confirmed
• □ Evidence of conformity with the old directives is complete
• □ Written confirmation that the device and its intended use have not changed significantly since the old certificate was issued
• □ Evidence that a QMS was implemented before May 2024 can be produced
• □ Evidence of a contract with a notified body signed before September 2024 can be produced
• □ The post-extension CE expiry date has been entered into the Israeli renewal dashboard (Section 12(2) of the Regulations)

Regulatory information verified as of 29 October 2026. The regulation names, numbers, publication dates and article numbers cited in this article were checked against official Israeli legal databases and authoritative public sources on that date. AMAR procedural documents are updated frequently, so before any formal submission please rely on the current version published on the website of the Israeli Ministry of Health.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Israeli market. Our team manages adverse event reporting and recall coordination with the MOH, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com