For MDR, the part in English is at page 38.
To be noticed some significant changes
- In Annex VII regarding the fact “ that the entire range of devices covered by the certificate is sampled”
- In Annex IX regarding “by the assessment of technical documentation for devices selected on a representative basis as specified in Section 4.”
- In Annex IX regarding ‘The notified body shall assess the technical documentation using staff” with deletion of “emploed by”
For IVDR, the part in English is in page 46