The Commission has published a guidance document for medical devices related to COVID-19. The document gives a rough overview of the regulatory framework. In the annex there is also a list of harmonised standards which are of particular importance for these medical devices. Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context.
Another guide from the EU Commission helps economic operators and users to check whether medical devices and personal protective equipment can be legally placed on the market in the context of COVID-19: How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used–also in the COVID-19 context.
Austrian Standards currently provides some COVID-19 relevant standards free of charge.
Depending on the manufacturer's claims, protective masks can be marketed as medical devices and/or personal protective equipment (PPE). In addition, since 04.04.2020 it has been possible to place protective masks on the market as quick mouth and nose masks in accordance with Article 28 of the 3rd COVID-19 Act. There are therefore three types of protective masks which are of particular importance in coping with the COVID-19 pandemic and are subject to different legislations.
The BASG can only establish responsibility for those protective masks that are marketed as medical devices within the meaning of the Medical Devices Act.
For further information on this topic, please refer to the website of the Federal Ministry of Health (FAQ: Mechanische Schutzvorrichtung (MNS) and to the website of the Federal Ministry of Digitalisation and Business Location (Coronavirus Maßnahmen).
Within the scope of market surveillance, it was observed that there are currently uncertainties regarding the correct placing of protective masks on the market. If protective masks are placed on the market as quick mouth and nose masks, it should be noted that the products are not nationally certified and have not been medically or otherwise tested. Particular care shall be taken to avoid giving the impression that the Quick-Mouth Masks are medical devices.
However, if protective masks are marketed as medical devices, they are subject to the Austrian Medical Devices Act (MPG). In this context, it should be noted that the trade with medical devices is subject to regulated trade.
As the COVID-19 pandemic is rapidly increasing the need for ventilators, the Medical Device Coordination Group, in collaboration with Member States, has developed a document on regulatory requirements for ventilators and their accessories. The document presents various options that manufacturers can use to place these products on the European market: Regulatory Requirements for Ventilators and Related Accessories
3D printed products can be used to manufacture medical devices. A document has been published on the European Commission's website to answer regulatory questions about 3D printing in the medical field.
COVID-19 Tests - Documents on performance criteria
In relation to SARS-CoV-2 testing, its important role in pandemic management and in view of the rapid and large increase in its number on the EU market, the European Commission has published, among others, the following documents:
- For effective management of the different phases of the pandemic, it is crucial what information can be provided by different tests, i.e. what is the intended purpose of a particular test and what is the level of performance of a test, i.e. how well it is able to achieve that purpose. Guidelines on COVID-19 in vitro diagnostic tests and their performance provide guidance on these aspects. They describe the regulatory framework for COVID-19 related in vitro diagnostic tests in the EU and provide an overview of the different types of tests and their purposes.
The performance criteria proposed in the document Current performance of COVID-19 test methods and devices and proposed performance criteria - Working document of Commission services are intended as additional temporary emergency guidance in view of the COVID-19 pandemic, which cannot replace the essential requirements of Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) or Regulation (EU) 2017/746 (IVDR). Ultimately, it is the responsibility of manufacturers to bring devices into full compliance with all requirements of the IVDD or IVDR. Proposed performance criteria will address in more detail the requirements for instructions for use and labelling, quality control, safety measures, analytical and clinical performance of RT-PCR tests, antigen and antibody tests. Annexes provide lists of commercially available tests and scientific literature, and information on how to search for validation studies.
Positive control material for SARS-CoV-2 virus developed by JRC
The control material developed by the European Commission's Joint Research Centre (JRC) is made available primarily - but not exclusively - to reference laboratories in the Member States and the research community.
COVID-19 tests - delimitation and responsibilities
PCR (polymerase chain reaction) tests, antigen tests (used for the detection of a current COVID 19 virus infection) and also antibody tests (used for the detection of antibodies during and after a COVID 19 virus infection), which are currently available in Austria, are basically to be classified as in vitro diagnostic products according to § 2 para. 5 MPG. As the PCR tests, antigen tests and antibody tests currently marketed in Austria require in principle after sampling by the test person, analysis by a laboratory or a competent person to obtain a result of the test, they are not subject to the provisions for in vitro diagnostic products for self-testing (such as pregnancy tests) according to § 2 para. 5a MPG.
According to the current state of knowledge of the Federal Office for Safety in Health Care, in vitro diagnostic products for self-testing arenot marketed in Austria.
This distinction is decisive for the conformity assessment procedure to be carried out before marketing, which guarantees the safety and conformity of the tests. While COVID-19 tests for self-testing would require the involvement of a Notified Body as an independent testing authority before market access, the manufacturer alone is responsible for the fulfilment of the legal requirements in the current COVID-19 tests, which are not in vitro diagnostic products for self-testing due to their intended purpose.
This means that before marketing these COVID-19 tests, the manufacturer must check the safety and conformity of the tests in a conformity assessment procedure he has carried out himself. After completion of this self-testing, the manufacturer must provide proof of safety and conformity by affixing the CE mark to the test itself.
The involvement of a Notified Body or the Federal Office for Safety in Health Care (BASG) as market surveillance authority is therefore not planned before COVID-19 tests are marketed.
The BASG is responsible for COVID-19 tests after the tests have been marketed as part of market surveillance and vigilance . Within the scope of this responsibility, the BASG examines suspicions that indicate non-conformity of the tests and takes measures (for example, additional claims within the scope of the investigation procedure or prohibition of marketing) to ensure the required conformity.
Further information on COVID-19 tests: