Devices for Protection - the regulatory framework

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.
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Types of devices and their regulatory scope

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Directive 93/42/EEC on medical devices (MDD) repealed by Regulation 2017/745 (MDR) effective from 26 May 2021.

Diagnostic self-tests 

Directive 98/79/EEC on in-vitro diagnostics medical devices repealed by Regulation 2017/746 with effect from 26 May 2022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.

Medical Devices Regulation application has been postponed by one year

The legislative act was published in the EU Official Journal which means:

  1. The entry into force has been postponed from 26 May 2020 to 26 May 2021, and
  2. The possibility for EU-wide derogations to be given to critically needed devices, as foreseen in Article 59(3) with immediate application”.

 

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:

What to do when there is a need for derogation

 

When deciding the need for a derogation, Member States will consider: 

  • the degree of criticality of the use of the device for the protection of health.
  • availability of suitable substitutes.
  • proof 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. 

 

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. 

 

 

Further information on Protective Personal Equipment