AMAR Registration and MDR: EU Authorized Representative for Israeli Manufacturers
Most Israeli device and diagnostics companies already hold a CE mark, because the Ministry of Health's Medical Device Division registers devices on the strength of approvals granted in recognised countries and asks to see the European declaration of conformity itself. That makes the Israeli position unusual: the question is rarely whether to enter the Union market, but whether the European certificate the Israeli registration was built on is still doing its job under MDR. For software and IVD companies, Rule 11 and the IVDR classification rules have often quietly changed the answer.
The Israeli register asks to see your European paperwork
Registration in the Medical Equipment Register is required before a device may be marketed in Israel, under the Medical Equipment Law 5772-2012 and the registration regulations of 5773-2013, and it is administered by the Medical Device Division of the Ministry of Health — the division everyone calls AMAR. What makes Israel unlike almost every other market in this cluster is what the Division asks the applicant to file.
The Division’s registration procedure REG-2024/03 lists, among the required documents, regulatory approvals from recognised countries as defined in the Law: FDA approvals such as 510(k) and PMA, CE regulatory approvals from recognised European countries, and a Declaration of Conformity under European regulation for all products submitted. In other words, the European file is not a parallel project for an Israeli manufacturer. It is the document the Israeli registration leans on.
Which produces a consequence most companies notice only when it bites: when the European certificate underneath the Israeli entry changes, the Israeli entry has to change too.
A quiet dependency: the declaration route and where it stops
Since procedure REG-2023/04 the Division has operated a declaration route, in which registration rests on the registration holder’s own declaration rather than a full technical review. It is open to a defined slice of the portfolio: class I, Is, Im and Ir devices, and low-risk laboratory products — class Other under the IVDD and class A under the IVDR. The declarant confirms that the device is registered or approved for marketing in a recognised country and actually marketed there, that the device and its manufacturer meet that country’s legal requirements — the form offers the European Union, the FDA, Canada and Australia as boxes to tick — and that manufacture is under conditions conforming to ISO 13485.
So the Israeli fast lane is defined by European and American class. Move a device up a class in Europe and it can fall out of the Israeli declaration route at the same moment. That link between two regulators’ classification decisions is worth understanding before you plan either submission.
Rule 11 and the Israeli software portfolio
Israel exports diagnostic and decision-support software, imaging analysis and AI-driven tools in far greater proportion than its size suggests, and Rule 11 of MDR Annex VIII is the provision that reorganised that portfolio. It reads: "Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: — death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or — a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb." (MDR Annex VIII, Chapter III, Rule 11)
Under the MDD, a large share of this software was class I and self-declared. Under MDR the same intended purpose commonly lands in class IIa or IIb, which means a notified body, an Annex IX quality management system assessment, a clinical evaluation built for software under Annex XIV, and a post-market clinical follow-up plan. The knock-on effects run in three directions at once.
| Where the device sat under the MDD | Where MDR puts it | What that does to the Israeli file |
|---|---|---|
| Decision-support software, class I, self-declared | Class IIa or IIb under Rule 11, notified body certificate required | Leaves the declaration route; standard registration with a notified body certificate |
| Non-sterile, non-measuring instrument, class I | Class I still, self-declared | Declaration route remains available |
| Reusable surgical instrument, class I | Class Ir, notified body involvement for the reprocessing aspects | Still within the declared classes, but the supporting certificate changes |
| General IVD reagent, self-declared under the IVDD | Class B, C or D under IVDR Annex VIII, notified body required | Leaves the low-risk laboratory category the declaration route depends on |
The certificate in the drawer, and how long it still counts
Many Israeli companies obtained a CE mark years ago through an arrangement that has since gone quiet — a European distributor who held the representative role, a group company that has been restructured, a notified body that lost its designation. The certificate is filed, the Israeli registration cites it, and nobody has looked at it since.
MDR Article 120 decides whether it still supports placing devices on the Union market. Certificates issued under the MDD or AIMDD that were valid on 26 May 2021 may support placing on the market until 31 December 2027 for class III devices and class IIb implantable devices other than the listed exceptions, and until 31 December 2028 for other class IIb, class IIa and class I devices placed on the market in sterile condition or with a measuring function. Devices that were self-declared under the MDD but need a notified body under MDR run to 31 December 2028.
Those dates are conditional, and the conditions have already passed. The manufacturer had to have a quality management system in place under Article 10(9) and to have lodged a formal application with a notified body by 26 May 2024, with a written agreement signed by 26 September 2024. If those steps were not taken, the legacy certificate is not carrying the device into the Union whatever date appears on its face — and the Israeli registration that cites it is resting on a document that no longer does the job it was filed to do.
Appointing the representative, and the twenty-four languages behind it
An Israeli manufacturer has no registered place of business in a Member State, so Article 11 applies without qualification: a sole authorised representative, designated in a mandate accepted in writing, effective at least for a whole generic device group. The mandate must require the representative to "verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;" (MDR Art. 11(3)(a)) — which is a real review of your file, not a signature.
Two operational points follow. Competent authorities may require information in an official Union language they determine, and instructions for use have to be supplied in the languages of the Member States you sell into; a company used to Hebrew and English artwork should budget for that early. And the representative name and address join the label under Annex I. Actor registration and an SRN follow through EUDAMED registration; the mandate itself is described on our EU Authorized Representative service page.
Questions from Israeli manufacturers and registration holders
Our Israeli registration holder handles everything. Can they be our EU representative?
No. The registration holder role exists under the Medical Equipment Law and sits in Israel; Article 11(1) requires a representative established in a Member State. The two roles are structurally similar — each is a local legal person carrying documented obligations for a foreign manufacturer — but neither substitutes for the other.
Our CE mark was arranged through a European partner years ago. Whose is it?
That depends on whose name appears as manufacturer on the declaration of conformity and the certificate. If the partner was named as manufacturer, the certificate is theirs and not transferable by agreement alone. This is the first thing we check for Israeli clients, because it determines whether you are appointing a representative or rebuilding a file under your own name.
Does an FDA clearance help us in Europe the way it helps us in Israel?
Not in the same way. The Israeli declaration route expressly accepts approval in a recognised country, and the FDA is one. MDR contains no equivalent reliance mechanism: conformity is assessed against Annex I and, above class I, certified by a notified body. Your 510(k) evidence is often reusable material, but it is not a route.
We are an IVD company. Is the position different?
The structure is the same — IVDR Article 11 mirrors MDR Article 11 — but the classification shift is larger. Assays that were self-declared under the IVDD are routinely class B or C under IVDR, and companion diagnostics and high-risk assays reach class D with its additional requirements. Send us the assay list and we will class it before you commit to a notified body slot.