March 15th and April 9th, 2021, three new guidance documents were released by the Medical Device Coordination Group (MDCG). These new documents offer guidance on state of the art of COVID-19 rapid antibody tests (MDCG 2021-2), provide Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG 2021-3) and clarify the application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 (MDCG 2021-4).
MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests.
This guidance is relevant to developers of rapid COVID-19 antibody tests as it identifies minimum performance criteria as well as considerations for devices intended to detect antibodies against SARS-CoV-2.
The guidance document states that for diagnostic sensitivity evaluation the positive sample panel should include at least 200 samples from individuals with a confirmed diagnosis of a SARS-CoV-2 infection with details on timing between sampling and potential onset of symptoms. Generally, at least 90% diagnostic sensitivity for each antibody type (IgM, IgG or total Ig) is required.
For diagnostic specificity evaluation, the negative panel should include at least 200 samples derived either from patients tested for antibodies for SARS-CoV-2 and confirmed as negative, or samples collected prior to November 2019, before the first COVID-19 cases were detected. Diagnostic specificity should be at least 98%
The document also states that when providing estimates for diagnostic sensitivity and specificity, a 95% confidence interval is recommended.
MDCG 2021-3 Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices.
This guidance addresses the most pertinent questions relating to custom-made devices under the MDR 2017/745. Custom-made devices (CMDs) have been defined in the MDR as devices made specifically in accordance with a written prescription by an authorized person that have specific design characteristics and are intended for the sole use of a particular patient to address their individual condition and needs.
MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746.
This guidance provides indications for how to apply the IVDR provisions related to expert panels and European Reference Laboratories (EURL) during the IVDR transition period, i.e., before 26 May 2022.
While IVD expert panel has been appointed, EURLs have yet to be designated. The EU Commission is still working to issue several implementing acts related to the EURLs and the fees they may charge.
According to this document, during the transition period, notified bodies may accept applications from manufacturers for class D IVDs but cannot issue certifications before the expert panel is operational or before the panel has provided its views on devices that require consultation.
According to this document, further guidance is being prepared to help notified bodies determine whether IVDs must undergo expert panel consultation, when the certification would be the first for a specific type of device and where no common specifications exist.
Notified bodies may also accept applications and issue certificates for class D IVDs during the transition even if a EURL has not been designated for that specific device, category or group of devices. These certificates will remain valid until their expiry date, even if a EURL is designated for the device at a later date. However, manufacturers and notified bodies should follow EURL-related provisions for sample and batch testing from the time a EURL becomes operational.
What does this mean to you?
You are strongly advised to read and act upon the MDCG guidance documents that may be applicable to your devices.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.