In my audits for certicying agencies I often see that the following points are not or not fully complied with:
- requirements of Art. 120 (3) MDR for legacy devices (devices, with 93/42/EEC certificates (MDD)):
- post-market surveillance acc. to Art. 83 - 86 MDR
- vigilance acc. to Art. 87 and 88 MDR
- registration of economic operators acc. to Art. 30 and 31 MDR
- registration of products acc. to Art. 29 MDR
- Usability - often the harmonized standard EN 62366 is unknown and, thus, not complied with
- Risk analysis - often does not or not fully comply with EN ISO 14971
You are most welcome to ask for support to comply with the respective requirements!