Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

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Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices

According to different application scenarios of COVID-19 reagents, The EU has made new regulations on the certification process of reagents, including the following regulations on the application scenarios of COVID-19 reagents:

Professional use in hospitals and laboratories

Close to patients: hospital beds, nursing homes, pharmacies, doctors’ offices

Self-testing at home is performed by ordinary people with no medical or laboratory training

By 26 May 2022, the CE mark of IVDD can be used for COVID-19 reagents used in professional places without the approval of the announcing body. Therefore, there is no CE label number and no NB certificate. The manufacturer only needs to provide the Declaration of Conformity (DOC), preferably with QMS certificate, but not mandatory by IVD Directive (IVDD).

For home self-testing of COVID-19 reagent, the product must have the CE approved by the IVDD notification agency, and the manufacturer must obtain the CE symbolic declaration issued by NB, plus the QMS certificate, before it can be sold in the European market.

In addition, enterprises that have obtained the self-testing certificate of IVDD may be required to supplement clinical data according to the new guidelines, or the certificate will be cancelled.

For Chinese in vitro diagnostic(IVD) companies that once were in the leading position of the European COVID-19 testing market, as well as in vitro diagnostic(IVD) companies that still want to enter the European market, the new clinical trial guidance makes it much harder to enter the European market.

Get more information from European Commission (public health)

Introduction

This guidance document concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs. The guidance is addressed to all interested parties, including notably the manufacturers, as well as notified bodies and competent authorities, authorised representatives, other market operators, professional and patient associations.

The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months. The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

The terms “IVD”, “device”, “assay” and “test” are used interchangeably in this text.

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