| Theme | Clinical evaluation |
| Target Audience | Manufacturers, NB |
| Products concerned | Orphan medical devices |
| Documents mentioned | MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states |
These are guidelines for manufacturers and notified bodies concerning the clinical evaluation of medical devices classified as “orphan” and medical devices with “orphan indications”, regardless of their class.
This document is divided into two parts:
- Clinical evaluation considerations :
- Acceptability of limitations in pre-market clinical data for orphan devices,
- Key considerations in the clinical evaluation of new and existing orphan devices,
- Production of post-market clinical data for orphan devices, including PMS and PMCF.
- Procedural considerations
- Guidance for Notified Bodies on the assessment of orphan devices,
- Role of expert groups in the context of orphan devices.