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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Luminita Barbu

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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Surgical masks, examination gloves and some types of gowns	Directive 93/42/EEC on medical devices (MDD) repealed by Regulation 2017/745 (MDR) effective from 26 May 2021.
Diagnostic self-tests	Directive 98/79/EEC on in-vitro diagnostics medical devices repealed by Regulation 2017/746 with effect from 26 May 2022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.

Warning against counterfeit products

Medical Devices Regulation application has been postponed by one year

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

The entry into force has been postponed from 26 May 2020 to 26 May 2021, and
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:

Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonized standards for medical devices drafted in support of Council Directive 93/42/EEC provides a complete list of references of harmonized standards drafted in support of Directive 93/42/EEC, some of them referring to critical medical devices, such as medical face masks (EN 14683:2019), surgical drapes and suits (EN 13795:2019), sterilization (EN ISO 13408:2018 and EN ISO 25424:2019). A similar legislative text has been adopted for in vitro diagnostic medical devices.
Such standards intended for critical medical devices are being made available for manufacturers to download free of charge from the online catalogues.
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context – a Q&A document containing a recap of how to ensure compliance with the regulations in force, including registration obligations and off-label use risks and solutions. The document tackles the possibility of derogations, according to Article 11 of MDD and Article 52 of MDR concerning major circumstance that may be invocated for Member State to authorize the placing on the market of individual devices for which the conformity assessment procedures haven´t been carried out yet.
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 - outline alternative solutions to on-site audits by Notified Body to avoid the risk of medical device shortages.

Commission Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat provides two scenarios in which critical devices, may be placed on the market even if the conformity assessment procedures have not yet been finalized or (exceptionally) initiated:
- Possibility to supply to different Member States without having gone through the full CE marking process, potentially on the basis of compliance with certain standards.
- An EU wide large authorization, meaning that manufacturers do not need to approach individual Member States to get national derogations.

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.

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.

Further information on Protective Personal Equipment

Conformity assessment procedure for PPE – a Q&A document that clarifies how a medical device or a PPE can be manufactured to be in line with the technical solutions as they are detailed either in the harmonized standards EN 149:2001+A1:2009 (for the FFP-type masks) and EN 14683:2019 (for surgical masks) or the WHO recommendations on the choice of protective equipment. The document also refers to recommendations and testing protocols developed by a number of Member States, i.e. Germany, Spain, the Netherlands and Belgium.

Technical specifications of personal protective equipment for COVID-19: this WHO document provides interim guidance on the quality, performance characteristics and related standards of personal protective equipment (PPE) to be used in the context of COVID-19.

ECDC has issued a recommendation on using face masks and other face covers in the community by individuals who are not ill.

Q&A : 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 (English - Chinese Version)