MDCG prods COVID diagnostic makers to assess variants

Regulatory NewsRegulatory News
| 17 May 2021 | By Michael Mezher 

The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests.
“The notice underlines the manufacturers’ responsibilities to continually assess the impact of newly identified genetic variants of SARS-CoV-2 on the capability of those IVDs to meet their performance, risk and safety claims,” MDCG writes.
The emergence of several SARS-CoV-2 variants of concern, including those identified in the United Kingdom, South Africa, Brazil and more recently in India, has raised concerns that some mutations may reduce the efficacy or performance of vaccines, therapeutics or diagnostics for COVID-19. In February, the US Food and Drug Administration (FDA) released a suite of guidance providing recommendations for addressing variants across four medical product areas, vaccines, drugs and biologics, monoclonal antibodies and diagnostics. The same month, the European Medicines Agency (EMA) issued guidance on the development of vaccines tailored to COVID-19 variants. (RELATED: FDA unveils plans to tackle COVID variants, Regulatory Focus 22 February 2021; EMA releases guidance for COVID variant vaccine development, Regulatory Focus 25 February 2021).
According to the MDCG notice, IVDs must continue to meet the essential requirements that pertain to them set out in Annex I of Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), as well as postmarket surveillance obligations set out in Annex III(5) of the directive.
“Depending on the design of the device and nature of the genetic variant this may result in failure to achieve the performance claims specified in the instructions for use. This could compromise the safety of patients, healthcare professionals or other individuals where a SARS-CoV-2 infection goes undetected,” MDCG wrote in the notice.
As such, manufacturers are obligated to continually assess the impact of new SARS-CoV-2 variants on the performance of their tests and ensure the risks associated with their test continue to be acceptable. Manufacturers are instructed to document their approach to assessing the impact of variants on their tests and to be ready to provide such documentation upon request.
Manufacturers are also responsible for reporting any incidents involving their tests to the relevant competent authority and for communicating any changes in the performance of their products that could cause direct or indirect harm to end users through a field safety corrective action.


© 2022 Regulatory Affairs Professionals Society.

Tags: coronavirus, EU, IVDs, MDCG

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