1. In vitro medical devices: how businesses can successfully comply with the new European regulation.
- Author
-
Moan B and Rabin N
- Subjects
- Clinical Laboratory Techniques instrumentation, Clinical Laboratory Techniques standards, Equipment Safety, Europe, Humans, Patient Safety, Commerce legislation & jurisprudence, European Union economics, Medical Device Legislation economics, Reagent Kits, Diagnostic classification, Reagent Kits, Diagnostic economics, Reagent Kits, Diagnostic standards
- Abstract
The European parliament finally approved the new European in vitro diagnostic regulation (IVDR) on 5 April 2017. This new regulation is shaking up the industry as it has a wider scope than its predecessor, meaning manufacturers of in vitro diagnostic medical devices must revise their compliance strategies exhaustively. In order to help manufacturers begin the process of compliance, this article highlights the principal changes in the regulation, providing a starting point for industry players. Furthermore, the article draws attention to other obstacles to conformity, in particular the shortage of notified bodies, the organisations designated by member states to carry out compliance evaluations. In addition to the commercial stakes for businesses, it is essential to bear in mind the ultimate objective of this overhaul of the regulatory framework, namely, to improve patient safety.
- Published
- 2018
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