Principles of ideal diagnostic regulation and the IVDR.
Clin Chem Lab Med
; 61(4): 599-607, 2023 03 28.
Article
in English
| MEDLINE | ID: covidwho-2197305
ABSTRACT
This article discusses principles and concepts for ideal regulatory frameworks for diagnostics, and the expression of those principles in the EU IVDR. The authors present the benefits of regulatory frameworks and implementation approaches for diagnostics that are risk-based, globally convergent, connected, nimble and efficient, under the IVDR and with a future outlook. While many expressions of these principles can already be found in the EU IVDR text, and in its implementation approaches, their further embrace is needed in future EU diagnostic regulation. In the long term outlook, risk-based approaches can be extended to comprise entity-based excellence appraisals. Globally convergent approaches can be more explicit in e.g. qualification and classification of products. This will also help further reliance models. Better connections and cooperation between regulators across the healthcare spectrum including pharmaceuticals should be fostered. Nimble approaches such as Emergency Use Authorisations for pandemics are essential in highly regulated schemes like the IVDR and beyond. Finally, regulatory efficiency as in timely availability of IT infrastructure and oversight mechanisms is a distinguishing attribute of globally competitive diagnostic regulatory schemes. All the above needs consideration in the long term efforts to modernize the EU regulatory system, so that diagnostics can play their important role in clinical research as well as along the entire care continuum in the EU.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Government Regulation
Type of study:
Diagnostic study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Clin Chem Lab Med
Journal subject:
Chemistry, Clinical
/
Laboratory Techniques and procedures
Year:
2023
Document Type:
Article
Affiliation country:
Cclm-2022-1206
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