Authorization of medical devices in Europe in the context of COVID-19
The standard registration procedure* for medical devices, in vitro diagnostic devices (IVD) and personal protective equipment includes a Conformity Assessment. Depending on the risk class of MD, IVD and the category of personal protective equipment, the manufacturer either registers its product independently through the EUDAMED system (for non-sterile MDs that are not measuring instruments, I risk class), or applies to a notified organization (in the case of all other products) for an additional audit and then receives a declaration of conformity.
However, in special cases, such as the COVID-19 pandemic, the Commission of the European Union and Member States may grant temporary access to the market to those MDs that have not passed the standard registration path or extend the validity of declarations of conformity to certain MDs and determine the conditions under which such MDs may be placed on the market.
If we talk about active MD and MD for in vitro diagnostics, then to regulate their entry into the market in a pandemic, a guidance has been issued that determines, for example, the factors that will influence the decision of the authorized bodies of the Member States. These include:
- The degree of criticality of the use of the device for the protection of health;
- Availability of suitable substitutes;
- Documentation of compliance with a harmonised standard or other specific technical solutions ensuring fulfilment of the applicable essential requirements laid down in the relevant Directive;
- Review of reports of tests performed by competent bodies;
- Indications from vigilance and/or market surveillance.
The document emphasizes that MD can be released on the territory of a certain member state, for a certain period of time limited by circumstances (for example, the duration of a pandemic) or the appearance of registered analogues. Procedures and terms will differ depending on the state.
Recommendations were issued for the release of personal protective equipment under the simplified mechanism in March 2020. According to the document, in the context of the COVID-19 pandemic, in order to prevent a shortage of personal protective equipment, it is possible to bring non-CE marked masks, gloves, some types of gowns to the market of individual Member States. However, before bringing such MDs to the market it is necessary for the supervisory authorities to assess the product and its compliance with safety requirements. In addition, manufacturers of such MDs must initiate the procedure for obtaining a declaration of conformity in parallel with the introduction into circulation. It is important that only healthcare workers can use “unregistered” medical devices.
* This process is unfair to call “registration”, as it is carried out in a slightly different way, but in the Russian-language literature the term “registration” is firmly entrenched in practice and for simplicity also will be used in this article.