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 |
|---|---|---|
| MDR | Designated | Verify on NANDO ↗ |
| 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Per-regulation status (active / suspended / withdrawn) is not published in the EUDAMED payload — we show Designated and link to NANDO rather than a status we cannot verify.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 | 29 | 42.6% | |
| Supplemented | 23 | 33.8% | |
| Withdrawn | 14 | 20.6% | |
| Amended | 2 | 2.9% | |
| Total recorded | 68 | 100% |
+ 14 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 | 8 | |
| Class IIa | 21 | ||
| Class IIb | 34 | ||
| Class III | 30 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, ITALCERT SRL (NB 0426) has issued 68 certificates: 68 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
ITALCERT SRL (notified body 0426) is a Italy notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 68 certificates (68 MDR, 0 IVDR) to 39 manufacturers across 4 countries.
Lens 05 · Who relies on it
What it means: 39 distinct manufacturers across 4 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| NTC Srl | 🇮🇹 IT | 10 |
| EVOLUTIS | 🇫🇷 FR | 4 |
| GRUPPO FARMAIMPRESA SRL | 🇮🇹 IT | 4 |
| STERYLAB S.R.L. | 🇮🇹 IT | 4 |
| BRM Extremities S.r.l. | 🇮🇹 IT | 3 |
| BIOTEC S.R.L. | 🇮🇹 IT | 3 |
| SIFI S.p.A. | 🇮🇹 IT | 2 |
| Innate s.r.l. | 🇮🇹 IT | 2 |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇮🇹 IT | 2 | |
| 🇸🇲 SM | 2 | |
| 🇺🇸 US | 2 | |
| 🇫🇷 FR | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 | |
| 🇮🇹 IT | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇮🇹 Italy | 34 | |
| 🇫🇷 France | 2 | |
| 🇸🇲 San Marino | 2 | |
| 🇺🇸 United States | 1 | |
| across 39 manufacturers | 39 | 4 countries total |