MHRA
Competent authority · XI · London
A national competent authority for medical devices under the EU MDR/IVDR — market surveillance, vigilance and EUDAMED registration oversight.
A national body that oversees the application of EU medical-device regulation in its country — market surveillance, vigilance, economic-operator validation and EUDAMED registration oversight, under MDR Articles 101–108.
Explore every authority and economic operator registered in XI.
A national body that oversees the application of EU medical-device regulation in its country — surveillance, vigilance, and registration oversight.
No — that's a notified body. A competent authority supervises the market; it does not issue device certificates.
Sourced directly from EUDAMED. This record was last updated Jun 25, 2026.
Operators whose registration was validated by this authority.
| Operator | Role | SRN | Country |
|---|---|---|---|
| 1 Stop Medical Supplies Ltd | Authorised representative | XI-AR-000049273 | XI |
| 3B BlackBio Dx Limited | Manufacturer | IN-MF-000023698 | IN |
| 66 VISION TECH CO., LTD. | Manufacturer | CN-MF-000030050 | CN |
| Ability Matters Group Limited | Manufacturer | GB-MF-000021306 | GB |
| ACON Biotech (Hangzhou Linan) Co., Ltd. | Manufacturer | CN-MF-000057570 | CN |
| Acute Ideas Co., Ltd. | Manufacturer | TW-MF-000025282 | TW |