Notified body · Verified from EUDAMED
We show only what EUDAMED publishes. EUDAMED is still being populated — the absence of a certificate here does not mean none exists. Every figure links back to the official record so you can verify it yourself.
Lens 01 · Mandate
The regulations this body is designated under, plus any predecessor directives.
| Regulation | Designation | Authoritative record |
|---|---|---|
| IVDR | Designated | Verify on NANDO ↗ |
| MDR | Designated | Verify on NANDO ↗ |
| IVDD(legacy) | Designated (legacy) | — |
| MDD(legacy) | Designated (legacy) | — |
Per-regulation status (active / suspended / withdrawn) is not published in the EUDAMED payload — we show Designated and link to NANDO rather than a status we cannot verify. Official scope of designation is published on NANDO →
Lens 02 · From the certificates
Device-group families derived from the scope text of this body's issued certificates (often legacy nomenclature) — not the official NANDO designation scope.
Read from the certificate scope text, which is messy free-text and skews to legacy nomenclature. We render only the code families actually present rather than imply a modern device-group breakdown that isn't recorded.
Modern MDR device-group codes (MDA / MDN / MDS / MDT) are not yet populated on this body's certificates — consistent with the EUDAMED data ramp.
These families are read from the issued certificates' scope text (often legacy nomenclature), not the official NANDO scope of designation.
MDA — Active devices
MDN — Non-active devices
MDS — Devices with specific characteristics (horizontal)
MDT — Devices using specific technologies / processes (horizontal)
IVR — IVD devices, base group (design / intended purpose)
IVS — IVDs with specific characteristics
IVT — IVDs using specific technologies
IVP — Specific examination-procedure knowledge
IVD — Specific laboratory / clinical-discipline knowledge
Source: Commission Implementing Reg (EU) 2017/2185; MDCG 2019-14 (MDR) / 2021-14 (IVDR).
Lens 03 · Certificates
What it means: most of this body's certificates are live; a small share have ended or had adverse action.
| Status | Count | Distribution | Share |
|---|---|---|---|
| Issued | 35 | 49.3% | |
| Supplemented | 27 | 38% | |
| Amended | 9 | 12.7% | |
| Total recorded | 71 | 100% |
+ 0 expired (derived from the expiry date, not a EUDAMED status).
New certificates per year — the curve of EUDAMED adoption.
Lens 04 · What it certifies
What it means: higher classes (MDR III, IVDR D) carry the strictest scrutiny — a window into how high-stakes this body's work runs.
| Framework | Class | Certs | Distribution |
|---|---|---|---|
| MDR | Class I | 2 | |
| Class IIa | 9 | ||
| Class IIb | 24 | ||
| Class III | 44 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, ISTITUTO SUPERIORE DI SANITA' (NB 0373) has issued 71 certificates: 71 under the EU MDR and 0 under the EU IVDR. EUDAMED is still being populated, so this is a lower bound, not a complete history.
Across its issued certificates it has covered MDR Class I, IIa, IIb and III devices and IVDR Class A, B, C and D devices, including the highest-risk MDR Class III and IVDR Class D.
Yes. This body is designated under the EU IVDR (2017/746) and the EU MDR (2017/745), plus the legacy AIMDD, MDD and IVDD directives. Its official scope of designation is published on NANDO ↗.
In one line
ISTITUTO SUPERIORE DI SANITA' (notified body 0373) is a Italy notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 71 certificates (71 MDR, 0 IVDR) to 31 manufacturers across 4 countries.
Lens 05 · Who relies on it
What it means: 31 distinct manufacturers across 4 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | 🇮🇹 IT | 8 |
| S.A.L.F. S.p.A. Laboratorio Farmacologico | 🇮🇹 IT | 6 |
| ASSUT EUROPE SPA | 🇮🇹 IT | 6 |
| Italfarmacia srl | 🇮🇹 IT | 4 |
| SOFAR SWISS SA | 🇨🇭 CH | 3 |
| Micromed srl | 🇮🇹 IT | 3 |
| BETATEX SPA | 🇮🇹 IT | 3 |
| Diaco Biofarmaceutici srl | 🇮🇹 IT | 3 |
| 🇪🇸 ES | 2 | |
| 🇪🇸 ES | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇮🇹 Italy | 25 | |
| 🇪🇸 Spain | 3 | |
| 🇨🇭 Switzerland | 2 | |
| 🇨🇴 Colombia | 1 | |
| across 31 manufacturers | 31 | 4 countries total |