How does the CE certification process work for medical devices?

The CE certification process typically involves the following steps:

1. Product classification (I, IIa, IIb, III)
2. Preparation of technical file
3. Risk management and clinical evaluation
4. Installation of PMS and PMCF systems
5. Notified Body process if required.
6. UTS, UDI and EUDAMED records
7. Application of the CE mark to the product.