Guideline for Biobanks to comply with EU in vitro diagnostics regulation
| Main Author: | Anu Jalanko, Andrea Wutte, Outi Törnwall and Kurt Zatlukal |
|---|---|
| Format: | info Lainnya Journal |
| Bahasa: | eng |
| Terbitan: |
, 2017
|
| Online Access: |
https://zenodo.org/record/2597993 |
Daftar Isi:
- The new In Vitro Diagnostic Device Regulation (IVDR)1,2 introduces significant changes for IVD manufacturers that plan to market their products in Europe. In ADOPT BBMRI-ERIC the IVDR has been analyzed in terms of its risks and opportunities and together with national experts, explored the possible implications it presents for the biobanks in Europe. Based on the analysis, biobanks face a ‘window of opportunity’ due to legal obligations forced on IVD manufacturers. One of the major obligation for IVD manufacturers is to demonstrate clinical evidence, performance evaluation and performance studies3 in order to declare that the processes, product or service meet the relevant regulatory requirements. Hence, the manufacturers will be in need of quality samples and biobanks can provide samples with defined specifications to be used as pre-‐analytical controls.