The Commission has published a guidance document for medical devices related to COVID-19. The document gives a rough overview of the regulatory framework. The annex also contains a list of harmonized standards that are of particular relevance for these medical devices. Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context.
Another guidance document from the EU Commission helps economic operators and users to verify that medical devices and personal protective equipment can be legally placed on the market in the COVID-19 context:
Austrian Standards currently provides some COVID-19 relevant standards free of charge.
The Medical Device Coordination Group (MDCG) document Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices is aimed at manufacturers of SARS-CoV-2 in vitro diagnostic medical devices located in countries outside the EU or EEA who intend to place these devices on the EU market. The Communication highlights issues related to compliance with the requirements of Directive 98/79/EC that EU competent authorities have identified as problematic in their market surveillance activities. These issues may also be relevant for SARS-CoV-2 IVDs that are being transferred to Regulation (EU) 2017/746.
To manage the COVID-19 pandemic, mechanical protective devices are of particular importance. These are intended to reduce the risk of infection with the corona virus by retaining droplets when coughing, talking or sneezing. Mechanical protective devices include simple mouth-nose protection and various types of protective masks.
The simple mouth nose protection (community mask, everyday mask) is for private use and is not subject to any special legal requirements or test criteria.
Protective masks, on the other hand, can be marketed as medical devices (medical face masks, surgical masks) and/or personal protective equipment (FFP2, FFP3 masks), depending on the manufacturer's claims.
On the part of the BASG, responsibility can only be established with regard to those protective masks that are placed on the market as medical devices within the meaning of the Austrian Medical Devices Act (MPG).
Within the framework of market surveillance, it was observed that there are currently uncertainties regarding the correct placing on the market of mechanical protective devices. When placing mouth nose protection (without a medical purpose) on the market, special care must be taken to ensure that the impression is not created that the product is a medical device.
If, on the other hand, protective masks are placed on the market as a medical device, they are subject to the MPG. In this context, it should be noted that trade in medical devices is subject to regulated trade.
As the need for ventilators is growing rapidly due to the COVID-19 pandemic, the Medical Device Coordination Group, in collaboration with member states, has developed a document on regulatory requirements of 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 website answering regulatory questions around 3D printing in the medical field.
This document contains information on the conformity assessment procedure for 3D printing and 3D printed products for use in the medical field in the context of the COVID-19 pandemic:
In the case of COVID-19 tests for self-testing, the involvement of a Notified Body as an independent testing authority is always required prior to market access. After successful completion of the conformity assessment, the products are placed on the market with a CE marking, where the identification number of the Notified Body (4-digit number) is affixed next to the CE marking.
COVID-19 tests - documents on conformity assessment and performance criteria.
In relation to SARS-CoV-2 tests, their important roles in the management of the pandemic and in view of the rapid and large increase in their numbers in the EU market, the European Commission has published, among others, the following documents:
- The document COVID-19 Tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 provides, in the form of questions and answers, an overview of the different SARS-CoV-2 test types and clear information on the regulatory framework for SARS-CoV-2 in vitro diagnostics. In addition, questions regarding the roles of individual actors and performance criteria for these tests are included.
- For effective management of the different phases of the pandemic, it is critical to know what information different tests can provide, i.e., what is the intended purpose of a particular test, as well as what is the performance level 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 of 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, manufacturers are responsible for bringing products into full compliance with all requirements of the IVDD or IVDR. Proposed performance criteria elaborate on requirements for instructions for use and labeling, quality controls, safety measures, and analytical and clinical performance of PCR tests, antigen tests, and antibody tests. Appendices provide lists of commercially available tests and scientific literature, as well as 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 Member States and to the research community.
COVID-19 tests - delimitation and responsibilities
PCR (polymerase chain reaction) tests, antigen tests (used to detect a current COVID-19 virus infection) and also antibody tests (used to detect antibodies in the course of and after a COVID-19 virus infection) that are currently available in Austria are to be classified as in vitro diagnostics. Basically, a distinction has to be made between tests that are used by a laboratory or a competent person and tests for self-testing (such as pregnancy tests) that can be used by laypersons in the home environment.
This distinction is important in the pre-market conformity assessment process that ensures the safety and compliance of the tests. While the involvement of a notified body as an independent testing authority is mandatory for COVID 19 tests for self-testing prior to market access, the manufacturer alone is responsible for fulfilling the legal requirements for COVID 19 tests that are not intended for self-testing due to their purpose.
The involvement of the Federal Office for Safety in Health Care (BASG) as a market surveillance authority is not foreseen before COVID-19 tests are marketed. There is also no "certification"/validation/verification of COVID-19 tests as part of the conformity assessment procedure or after marketing by the BASG.
A responsibility of BASG for COVID-19 tests is given after marketing of the tests within the framework of market surveillance and vigilance. As part of this responsibility, BASG reviews suspicions that indicate non-conformity of the tests and takes action (for example, subsequent demands as part of the investigation procedure or prohibition of marketing) to ensure the required conformity.
More information on COVID-19 testing: