Apr 22, 2020
European Commissioners have published new guidelines covering performance and validation of COVID-19 in-vitro diagnostic device (IVD) tests, as well as identifying further steps needed to ensure appropriate and strategic use of these tests across European Union member states to better manage the public health crisis.
The new guidelines reiterate IVD device manufacturers’ obligations in terms of performance, intended purpose, instructions for use and other requirements under the In Vitro Diagnostic Devices Directive 98/79/EC. European Commissioners, member state Competent Authorities and other stakeholders, in turn, should also base collective approaches to IVD testing for COVID-19 infections on what they consider critical aspects of device performance, according to the guidelines.
So far, EC regulators’ efforts regarding IVD performance and EU market access have largely entailed information exchanges with member state authorities, the European Medical Device Coordination Group (MDCG), the World Health Organization, industry and other stakeholders.
The EC has also published guidance on conformity assessments and standards pertaining to IVD products, as well as working documents covering literature reviews and performance criteria, plus support for developing COVID-19 diagnostic and treatment products.
To further optimize utilization of IVD test kits across EU member states and support their national strategies, the EC plans additional efforts to ensure proper use, performance and validation of these tests:
Emergo consultants in Europe will monitor and report on the Commission’s progress achieving these goals to better manage the coronavirus outbreak.
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