Products to protect against infection for physicians, clinicians, nurses, pharmacists, retail employees and ultimately all of us are in short supply.

Against the backdrop of the increasingly dramatic wave of Covid-19 infections, the federal government as well as the individual states have made various appeals to industrial companies, asking for their support in providing urgently needed medical devices and protective equipment.

In recent days, there have already been several reports in the media that clothing manufacturers and tailoring companies are switching their production to the manufacture of protective masks and coats.

To ensure that these products also become effective medical devices, we would like to briefly present the crucial requirements here.

A distinction is made between:

Medical face masks, which as medical devices must comply with the requirements of the Medical Devices Directive 93/42/EEC or (theoretically) from 26.05.2020 with the Medical Devices Regulation 2017/745;

Particle filtering half masks for protection against particles according to class FFP1, FFP2 or FFP3, which as personal protective equipment (PPE) must meet the requirements of the Personal Protective Equipment Regulation 2016/425;

Surgical clothing, which as medical devices must meet the requirements of the Medical Devices Directive 93/42/EEC or (theoretically) from 26.05.2020 the Medical Devices Regulation 2017/745;

The specific product requirements are described in detail in the respective standards:

DIN EN 14683:2019-10 – Medical face masks – Requirements and test methods;

DIN EN 149:2009-08 – Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking;

DIN EN 13795-1:2019-06 – Surgical gowns and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns;

DIN EN 13795-2:2019-06 – Surgical gowns and drapes – Requirements and test methods – Part 2: Pure air gowns;

In addition, general, product-unspecific requirements also apply here, such as:

ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Assessment and testing in the context of a risk management system (see our article;

In the case of sterile products, the DIN EN ISO 11607-1/2:2017-10 family of standards – Packaging for medical devices to be sterilized in the final packaging;

In the case of reusable devices to be reprocessed, the DIN EN ISO 17664:2018-04 – Reprocessing of healthcare products – Information to be provided by the medical device manufacturer for the reprocessing of medical devices;

as well as other standards.

So how do we quickly get to usable medical devices?

The European Commission has already issued Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat ( ) on 13/03/2020. This includes calls to all market participants to act faster than usual and to clear the way for other technical solutions than covered by the harmonized standards. Furthermore, it encourages member states to grant exemptions from conformity assessment procedures and the relevant market surveillance authorities to focus on products that pose a serious risk to the health and safety of the user.

The key statement is this: “Where market surveillance authorities find that PPE or medical devices in compliance with the … essential requirements laid down … ensure an adequate level of health and safety, despite the fact that the conformity assessment procedures, including the affixing of the CE marking, have not been carried out entirely in accordance with the harmonized standards, they may authorize the making available of those products on the Union market for a limited period of time and while the necessary procedures are being carried out.”

This means that what matters is compliance with the essential Essential Safety and Performance Requirements – and then the products can be made available as quickly as possible to the people who are desperately waiting for them.

We support you in the fight against the Corona virus with our extensive knowledge of implementing medical device and personal protective equipment requirements.

We make our expertise in the development, manufacture and approval of medical devices available to all manufacturers who wish to use existing materials, technologies and experience for urgently needed products.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.