IVD Classification and Registration Routes under the EU IVDR

1. Key takeaways

For in-vitro diagnostic devices (IVDs), Israel adopts the four-tier A/B/C/D classification of the EU IVDR without setting up a national scheme, and shares three registration routes with devices: Class A follows the declaration route (immediate entry); Class B follows fast track 1 (about 45 working days, requiring reference-country approval and 4 months on the market); Class C follows fast track 2 (about 60 working days, requiring approval in two reference states and at least 6 months on the market in one of them); Class D follows the standard route (official target 120 calendar days). IVD registrations under the declaration route must be renewed annually, with a filing window from 1 October to 31 December each year. Because the IVDR class of a product can change during the EU transition, the route and schedule of each SKU should be re-derived from its current class. Searching AMAR materials under both IVD and laboratory equipment wording is the reliable way to collect every applicable document.

• IVD classification follows the EU IVDR A/B/C/D scheme.
• Class A: declaration route with immediate entry.
• Class B: fast track 1, about 45 working days, one reference approval plus 4 months of marketing.
• Class C: fast track 2, about 60 working days, two reference approvals plus 6 months of marketing in one.
• Class D: standard route, official target 120 calendar days; declaration-route registrations renew annually, window 1 October to 31 December.

2. Legal basis

The route mechanics for IVDs come from AMAR’s fast-track procedure and the declaration guidance, resting on the reference-state pathway in the 2013 regulations and the EU instruments. The elements cited in this article are listed below.

3. Expert insights

One terminological detail about IVDs in Israel deserves attention: AMAR documents commonly use laboratory equipment to refer to IVDs, which does not map exactly onto the IVDR terminology. When searching and preparing materials, companies must cover both sets of wording, otherwise applicable documents are easily missed.

The second point is the chain reaction of classification. After the IVDR took effect, many products classified as low risk under the IVDD were up-classified to Class C or even Class D. In Israel, an up-classification directly changes the route: from declaration route with immediate entry to fast track 2 or the standard route, stretching the timeline from 48 hours to 60 working days or longer. GRZAN’s judgment is that, while completing the IVDR transition in the EU, IVD companies should re-estimate their Israeli registration schedules at the same time, otherwise the gap appears of having obtained the CE mark yet moving more slowly in Israel.

The third point is the rigidity of the annual renewal window. Registrations under the declaration route require an annual declaration to be filed between 1 October and 31 December each year; missing the window means expiry. For companies with large numbers of Class A IVD products, this is an annual action that must be managed in batches, not handled case by case.

A fourth observation ties the three together: for IVDs, the route, the timeline and the maintenance obligation are all set by the IVDR class, so a single reclassification event changes three things at once – the approval documents to be assembled (one reference state or two), the marketing history to be evidenced (4 months or 6 months), and whether the registration renews on the annual declaration cycle or on the ordinary renewal route. Companies that maintained a flat portfolio under the IVDD now hold a stratified one, and the Israeli registration schedule of each SKU has to be re-derived from its new class rather than carried over from the old registration.

4. Practical recommendations

• Build an IVDR-to-Israeli-route mapping table: list each SKU’s IVDR class, corresponding route, timeline and marketing-history requirement in one table, updated in step with the IVDR transition.
• Manage the annual declarations in batches: file Class A and low-risk laboratory equipment collectively each year, with materials ready before 1 October.
• Archive marketing-history evidence early: evidence the 4-month / 6-month marketing history required for Classes B and C with a combination of orders, invoices and customs declarations.
• Watch the EU transitional arrangements: for IVDs still holding IVDD certificates, check that the transitional extension meets the conditions of Israel’s bridging document of 15 April 2024.

5. Verification checklist

• □ The IVDR class of each SKU has been confirmed and mapped one to one to the Israeli route
• □ Class A / low-risk laboratory equipment has been placed on the batch list for annual declarations, window 1 October – 31 December
• □ The 4-month (Class B) and 6-month (Class C) marketing-history evidence has been archived
• □ The number of reference-country approvals meets the requirement (at least 1 state for Class B, 2 states for Class C)
• □ The transitional status of IVDD certificates and the Israeli bridging conditions have been checked
• □ The labelling language strategy distinguishes home use from professional use

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

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 Ministry of Health (MOH) registrations under the Medical Devices Law 5772-2012, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com