Special approvals of the Federal Institute for Drugs and Medical Devices for the distribution of medical devices and FFP breathing masks without an expiration valve

In order to counteract the major supply bottleneck for mouth and nose protection masks (MNS) and filtering face piece masks (FFP), which exists worldwide due to the COVID-19 outbreak, the Federal Institute for Drugs and Medical Devices (BfArM) is currently making great efforts to issue special approvals in accordance with section 11(1) of the Medical Devices Act (MPG). As a result, medical devices which have not undergone a conformity assessment procedure in accordance with Directive 93/42/EEC and therefore do not bear a valid CE mark may still be placed on the market by means of special approval in accordance with section 11(1) MPG if their use is in the interest of health protection. Taylor Wessing has already advised numerous companies in connection with the sale of breathing masks, including the company Mey (Link to press release).

1. Mouth and nose protection masks (MNS)

Mouth and nose protection masks (MNS) are medical devices within risk class 1, for which the medical device manufacturer has to carry out a conformity assessment procedure, whereby a certification body - unlike for higher risk classes – does not need to be involved. If conformity with the requirements of the Medical Device Directive 93/42/EEC is determined during the conformity assessment procedure, the manufacturer may and must affix the CE mark to the medical device. However, the required conformity assessment procedure usually takes a few weeks.

If companies wish to market such masks in Germany beforehand without CE marking, an application for special approval can be submitted to the BfArM in connection with the COVID 19 pandemic in accordance with section 11(1) MPG. However, before this can be done, the respective mouth and nose protection mask must be tested by a recognized laboratory with regard to the requirements specified in standard DIN EN 14683:2019-6. Apart from this, the BfArM is authorised to recognise a valid approval in the USA, Australia, Canada or Japan if the masks are legally on the market there.

2. Filtering face pieces without an expiration valve (FFP masks)

Particle filtering face pieces (FFP masks), on the other hand, are not medical products but personal protective equipment (PPE) for which a conformity assessment procedure must be carried out in cooperation with a certification body (CE type examination) in accordance with PPE Regulation (EU) 2016/425. Only then may the masks bear the CE mark in accordance with the PPE Regulation and are marketable in the European Union.

The PPE Regulation (EU) 2016/425 falls within the remit of the Federal Ministry of Labour and Social Affairs (BMAS), while the Medical Device Directive 93/42/EEC falls within the remit of the Federal Ministry of Health (BMG). To remedy the acute shortage of breathing masks, the BMG and the BMAS have temporarily extended the application of the legal basis for the special approval of medical devices to include breathing masks of personal protective equipment (FFP2 and FFP3) if these do not have a CE mark in accordance with the PPE Regulation (EU) 2016/425 and are to be marketed as medical devices in the sense of medical face masks. The BfArM was authorised to grant special approval to FFP masks without an expiration valve as medical face masks to allow market access for Germany. The requirements for the special approval of mouth and nose protection masks according to section 11(1) MPG apply accordingly to FFP masks. The BfArM is also authorized to recognize approvals for FFP masks in the USA, Canada, Australia and Japan.

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We have compiled on our website comprehensive information and recommendations for action in response to the legal implications arising from the coronavirus pandemic: https://deutschland.taylorwessing.com/en/coronavirus