There is some confusion around what can and should be certified.
A Notified Body (NB) can certify the conformance to the regulation for medical devices and in-vitro diagnostics. This is true for all medical devices, except risk class I medical devices. For risk class I medical devices, a manufacturer can request a voluntary attestation of confomity (AoC) from its NB.
So, there are two types of certificates out there:
- Certificate of Compliance
- Attestation of Compliance