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 06 · Published fees
What it means: notified bodies must make their standard fees publicly available (Article 50 MDR, Article 46 IVDR). The European Commission keeps an index of the fee lists it has been given.
| Regulation | Fee list |
|---|---|
| MDR | CNCPS Conditions and FesPDF |
| IVDR | Centro Nacional - Information and ConditionsPDF |
Links come from the European Commission's index of notified-body fee lists. We link out to each body's own site — we do not host the documents, read the amounts, or check that a link still resolves. Index retrieved Jul 14, 2026. Open the source index →
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.
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 | 62 | 91.2% | |
| Supplemented | 5 | 7.4% | |
| Amended | 1 | 1.5% | |
| Total recorded | 68 | 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 | 13 | |
| Class IIa | 29 | ||
| Class IIb | 19 | ||
| Class III | 24 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (NB 0318) 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 ↗.
Lens 01 · Mandate
The regulations this body is designated under, plus any predecessor directives.
| Regulation | Designation | Authoritative record |
|---|---|---|
| IVDR | Active | Verify on NANDO |
| MDR | Active | Verify on NANDO |
| IVDD(legacy) | Designated (legacy) | — |
| MDD(legacy) | Designated (legacy) | — |
“Active” means the designation is currently valid in NANDO, the EU’s official register; where NANDO does not confirm an active status we show “Designated” and link out rather than a status we cannot verify. Active status verified on NANDO Jul 27, 2026. Official scope of designation is published on NANDO →
In one line
CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS (notified body 0318) is a Spain notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 68 certificates (68 MDR, 0 IVDR) to 49 manufacturers across 5 countries.
Lens 05 · Who relies on it
What it means: 49 distinct manufacturers across 5 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| 🇪🇸 ES | 6 | |
| 🇪🇸 ES | 6 | |
| 🇦🇷 AR | 4 | |
| 🇪🇸 ES | 2 | |
| 🇪🇸 ES | 2 | |
| 🇪🇸 ES | 2 | |
| 🇪🇸 ES | 2 | |
| 🇪🇸 ES | 2 |
| i+Med S.Coop. | 🇪🇸 ES | 2 |
| Deltalab, S.L. | 🇪🇸 ES | 1 |
| BARNA IMPORT MEDICA, S.A. | 🇪🇸 ES | 1 |
| Unolab manufacturing, S.L. | 🇪🇸 ES | 1 |
| SIBEL SAU | 🇪🇸 ES | 1 |
| CEX INTERNACIONAL, S.A. | 🇪🇸 ES | 1 |
| DM CEOSA | 🇪🇸 ES | 1 |
| OIARSO, S. COOP | 🇪🇸 ES | 1 |
| Meiji Pharma Spain, S.A. | 🇪🇸 ES | 1 |
| TEMEL S.A. | 🇪🇸 ES | 1 |
| Disop | 🇪🇸 ES | 1 |
| TEXTIL PLANAS OLIVERAS S.A. | 🇪🇸 ES | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇪🇸 Spain | 44 | |
| 🇫🇷 France | 2 | |
| 🇦🇷 Argentina | 1 | |
| 🇲🇽 Mexico | 1 | |
| 🇵🇹 Portugal | 1 | |
| across 49 manufacturers | 49 | 5 countries total |