COVID-19 Technical and regulatory information

Since the beginning of the current public health crisis, we have been continually faced with a massive influx of information which is constantly evolving.

We have created this page to help companies who want to manufacture the following essential products navigate through the COVID-19 fog: medical devices (MD), in vitro diagnostic medical devices (IVD), personal protective equipment (PPE), and alternative or “homemade” products.

You will find various regulatory, normative, and technical information relating to the manufacture and placing on the European market of these products. We will continue to update this page as new information becomes available.

Consult our GLOSSARY

All products placed on the market in the European Union must comply with the applicable regulatory requirements, which are based upon intended use and manufacturers claims, even during a state of emergency.

A specific regulation is affiliated with each of the categories defined on this page, hence the importance of determining the status of one’s product before designing and manufacturing it and placing it on the market.

Select the domain to consult the regulatory, normative, and technical sources

1) Medical Devices (MD)

Regulations

Standards

Informative documents

Competent authorities

Notified bodies:

Other:

2) Personal Protective Equipment (PPE)

Regulations

Regulations related to the export of PPE

Regulations related to the import of PPE

Standards

Informative documents

3) Alternative and Homemade Products

Regulations

Standards/Guidelines

Informative documents

4) In vitro diagnostic devices (IVD)

Regulations

  • 15/04/2020_ COMMUNICATION FROM THE COMMISSION Guidelines on COVID-19 in vitro diagnostic tests and their performance:
    • Outlines the regulatory context of COVID-19-relate IVD testing devices in the EU and gives an overview of the different types of tests and their purposes.
    • Considerations on device performance and validating that performance.
    • Elements to be considered by Member States in defining national strategies, and by economic operators in placing devices on the market.
  • 27/10/1998_ Directive 98/79/EC on in vitro diagnostic medical devices
    In particular Article 9, paragraph 12 : By way of derogation from paragraphs 1 to 4, the competent authorities may authorise, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 to 4 have not been carried out and the use of which is in the interest of protection of health.
  • 05/04/2017_ Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Informative documents

Documents published by the European Commission:

  • Commission working document: Current performance of COVID-19 test methods and devices and proposed performance criteria (last updated 16/04/2020)
  • 03/04/2020_ Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

Documents published by French Authorities

  • HAS (Haute Autorité de Santé – High Authority for Health)
    • 06/03/2020_ Avis n° 2020.0020/AC/SEAP du 6 mars 2020 on the inclusion in the list of acts and benefits mentioned in Article L. 162-1-7 of the Social Security Code, of the detection of the SARS-CoV-2 coronavirus genome by reverse transcription technique followed by amplification.
    • 06/04/2020_ Overview : Specifications defining the methods for evaluating the performance of serological tests detecting antibodies against SARS-CoV-2
    • 24/04/2020_ Note de cadrage : This note describes how serological testing should be incorporated in the COVID-19 disease management strategy.
    • 01/05/2020_ Evaluation report : This report presents a review on the place of serological testing in the COVID-19 disease management strategy

Documents published by Belgian Authorities

Documents published by the MHRA in the UK

Documents published by SwissMedic in Switzerand

Miscellaneous resources and other relevant links

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