The Placing on the Market of Personal Protective Equipment such as (Respiratory) Masks
In the course of the spread of the disease COVID-19, caused by the virus SARS-CoV-2, there is currently a high demand especially for products such as (respiratory) protective masks. This raises the question whether such products can easily be offered on the market. A distinction must be made, especially in the case of protective masks, because not all masks under consideration are subject to the same legal provisions and can be marketed as protective masks. On the one hand, masks can be classified as medical devices in the sense of the Medical Devices Act. As a medical device, the products are only marketable if they have undergone a conformity assessment procedure and bear the CE marking. In this context, we refer to our article of 1 April 2020 "Facilitating the placing on the market of medical devices in the course of the corona crisis". Furthermore, masks can be classified as personal protective equipment ("PPE"). PPE is subject to Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment ("PPE Regulati-on") which determines the requirements for technical design, manufacture and sale. As a third option, masks can be placed on the market as ordinary masks as long as they do not suggest a protective effect, in particular health protection, and are not dedicated to a medical purpose by the manufacturer. Due to the current situation, however, there is above all a need for masks that guarantee at least a certain level of health protection. The classification of the product as PPE would ensure a corresponding protective effect.
1. Marktability of PPE
Products can be marketed as PPE if the conditions prescribed by law are fulfilled. The requirements for the placing on the market of PPE are regulated in the PPE Ordinance and the PPE Implementing Act ("PSA-DG"). The PPE ordinance is directly applicable in Germany. According to these, a CE mark must be affixed to the product so that the product may be placed on the market. In accordance with Article 8 (2) in conjunction with Article 19 PPE Ordinance, the prerequisite for the CE marking is the implementation of the prescribed conformity assessment procedure. Here a distinction is made between three categories in accordance with Article 19 PPE Ordinance. The conformity assessment procedure is carried out by the manufacturer himself in the case of category I PPE and by notified bodies in the case of category II and III PPE. Accordingly, a PPE product has to overcome similar obstacles to marketability as is the case with medical devices.
2. Recommendation of the European Commission
In its Recommendation (EU) 2020/403 of 13 March 2020 the European Commission (EU Commission) has now presented measures to accelerate and simplify the procedures for the distribution of medical devices and PPE. According to the recommendation, it will in particular be possible to place medical devices and PPE on the market without CE marking. or PPE, the EU Commission proposes that the responsible market surveillance authorities evaluate the PPE products. Where products are found to be in conformity with the essential health and safety requirements of the relevant legislation, the market surveillance authorities are to take action to allow the placing on the market of such products for a limited period of time or while the conformity assessment procedure is ongoing. However, it must be ensured that products without CE marking are only made available to healthcare professionals, and only for the duration of the current health threat. Furthermore, the EU Commission recommends that the notified bodies give priority to the conformity assessment of newly submitted applications for PPE necessary for protection in connection with the outbreak of COVID-19 and carry it out rapidly. In this context, the EU Commission has determined, in addition to the previously harmonised standards, that the recommendations of the WHO can be used as a reference for other technical solutions, provided that an adequate level of protection is guaranteed. If notified bodies accept other technical solutions than the harmonised standards, they should immediately inform the notifying authority and other notified bodies of this possibility.
3. Implementation of the recommendation
A recommendation of the EU Commission is, however, not binding under Art. 288 TFEU. In contrast to medical devices, for which special approvals can be granted without carrying out the conformity assessment procedure in accordance with section 11 (1) German Medical Devices Act (MPG), there is no comparable regulation either in German law or in the PPE Ordinance. Rather, the placing of PPE on the market without carrying out a conformity assessment procedure or without CE marking can be fined, see section 8 PSA-DG.
The implementation of the conformity assessment procedure can be simplified or accelerated. According to Article 14 of the PPE Ordinance, PPE products which conform to harmonised standards or parts thereof are presumed to conform to the essential health and safety requirements. This legally disputable presumption shortens the conformity assessment procedure so that rapid market access can be facilitated. The EU Commission also appears to be seeking to create further harmonised standards which can then be referred to in the assessment procedure.
4. Protective masks without CE marking
An accelerated assessment procedure alone will probably not be sufficient to provide healthcare professionals with sufficient protective masks. In its recommendation of 13 March 2020, the EU Commission therefore proposes that protective masks should also be procured without CE marking, provided that it is ensured that these products are only made available to healthcare professionals and only for the duration of the current health threat. They must also ensure an adequate level of health and safety. In particular, the protective masks shall not enter the normal distribution channels. On 18 March 2020, the Federal Institute for Occupational Safety and Health ("BAuA") issued In the course of this the recommendation Recommendation to use masks for employees in the medical and care sector that comply at least with the NIOSH Standard N95. This means that protective masks that would be marketable in the USA, Canada, Australia and Japan are also considered marketable in Germany, even if no CE marking is present.
According to the BAuA, if a marketability is still not given after that, a notified body must check in individual cases whether the masks comply with the EU protection standard. DEKRA Testing and Certification GmbH ("DEKRA") and the Institute for Occupational Safety and Health ("IFA") have already developed one Audit principle in this context which makes it possible to determine within a few days whether the respective products guarantee an adequate level of health and safety. There is good reason to believe that once this testing principle has been carried out, the products can be used as protective masks in accordance with the recommendation of the Commission. DEKRA itself, however, points out that the masks tested in accordance with its auditing standards are not PPE in accordance with the PPE Ordinance. However, the Commission justifies the audit principle developed with under the recommendation of the EU Commission.
Measures are being taken at both EU and national level to meet the high demand for protective equipment. In light of the fact that recommendations of the EU Commission are not binding, for reasons of legal certainty it is questionable how, for example, masks without CE marking and without carrying out the conformity assessment procedure can be placed on the market as protective masks. This could also be of relevance with regard to the administrative offence provision in section 8 PSA-DG, whereas the actual prosecution of a possible administrative offence under section 47 (1) German Administrative Offences Act (OWiG) is at the discretion of the prosecuting authority. Due to the current amendment of the Infection Protection Act in section 5 (2) no. 4, it is obvious that the Federal Ministry of Health will create a legal basis in the short term by means of corresponding ordinances in order to comply with the recommendations of the EU Commission with regard to products such as protective masks. In this context, further legislation at EU level could also provide more legal certainty.
Dr Silke Dulle
Lawyer, Licensed Specialist for Medical Law