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.

EC actions so far regarding IVD test performance and market access

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.

Next steps for strategic use of IVD tests across the EU

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:

• Developing a common EU approach to COVID-19 testing that can be carried out on national levels;
• Establishing a platform for centralized information on IVD test performance, which will inform EU member states’ national-level strategies;
• Determining best practices for performance evaluation of COVID-19 tests, with MDCG issuing guidance as appropriate;
• Stepping up efforts in collaboration with member state governments to detect and remove counterfeit IVD test kits from the European market;
• Building a network of COVID-19 reference laboratories throughout the EU;
• EU-level coordination of supply and demand of IVD devices to test for COVID-19;
• Developing tools for use by EU member states and the EC to enable standardized comparisons of various IVD test kits’ performance.

Emergo consultants in Europe will monitor and report on the Commission’s progress achieving these goals to better manage the coronavirus outbreak.

Related European medical device regulatory resources from Emergo by UL:

• Emergency market access for medical devices and IVDs in Europe
• COVID-19 regulatory news and analysis resource center
• European MDR preparation support and resource center
• European CE Marking strategy for medical devices