In the context of the COVID-19 global outbreak, medical devices and personal protective equipment are essential for healthcare professionals and other personnel involved in the efforts to contain the virus and avoid its further spread.
Our industry plays a critical role in key categories of medtech products that help fight corona virus crisis. Rapid and accurate diagnostic tests, face masks, protective suits, etc. all of them are essential in this period.
This overview presents the regulatory framework specifically created to address challenges of ensuring the conformity of different type of devices in Europe.
|Types of devices||Applicable regulation|
Disposable and re-usable face masks and coveralls, gloves and eye-wear protection, which are used for prevention and protection against harmful biological agents such as viruses
Regulation (EU) 2016/425 on personal protective equipment (PPE)
Surgical masks, examination gloves and some types of gowns
Directive 98/79/EEC on in-vitro diagnostics medical devices repealed by Regulation 2017/746 with effect from 26 May 2022
The above-mentioned regulatory frameworks lay down essential requirements for health, safety and performance for the products that it covers in order to ensure protection of the health and safety of users.
Products manufactured in accordance with these rules can circulate freely throughout the internal market of the European Union.
The legislative act was published in the EU Official Journal which means:
For devices specifically needed to help combat the COVID-19 outbreak, the European Commission has released specific legislative acts and guidance documents that provide manufacturers with tools to speed up the conformity assessment procedures:
When deciding the need for a derogation, Member States will consider:
Such a derogation will be limited in time to what is strictly required for rendering the device compliant with the legislation or, if earlier, when suitable substitutes can be expected, or the critical needs will no longer be present.
An overview of the regulatory requirements for medical face masks providing options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic is available here.