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 | NSAI Updated Pricelist 2024PDF |
| IVDR | NSAI Medical Devices - Updated Pricelist 2024PDF |
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 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 | 5 | 100% | |
| Total recorded | 5 | 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 III | 5 |
A certificate may cover several risk classes; these counts are not additive.
Common questions
Based on EUDAMED data, National Standards Authority of Ireland (NSAI) (NB 0050) has issued 5 certificates: 5 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
National Standards Authority of Ireland (NSAI) (notified body 0050) is a Ireland notified body designated under the EU MDR and IVDR. Based on EUDAMED data, it has issued 5 certificates (5 MDR, 0 IVDR) to 3 manufacturers across 2 countries.
Lens 05 · Who relies on it
What it means: 3 distinct manufacturers across 2 countries rely on this body.
| Manufacturer | Country | Certs |
|---|---|---|
| Biosensors Europe SA | 🇨🇭 CH | 2 |
| CVRx, Inc. | 🇺🇸 US | 2 |
| Lake Region Medical | 🇺🇸 US | 1 |
| Country | Manufacturers | Share |
|---|---|---|
| 🇺🇸 United States | 2 | |
| 🇨🇭 Switzerland | 1 | |
| across 3 manufacturers | 3 | 2 countries total |
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) | — |
| AIMDD(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 20, 2026. Official scope of designation is published on NANDO →