On 26.05.2020, the Ordinance of the Federal Ministry of Health (BMG) to ensure the supply of the population with products of medical need during the epidemic caused by the coronavirus Sars-CoV-2 (MedBVSV) entered into force. According to Sec. 1 Para. 1 MedBVSV, it serves “to ensure the supply of the population with products of medical need during the epidemic situation of national importance determined by the German Bundestag“. According to Sec. 1 Para. 2 MedBVSV, items of personal protective equipment (PPE) are also products of medical need.
As was previously the case in the draft of 06.04.2020 PPE is referred to in Sec. 9 MedBVSV: Sec 9 Para. 1 MedBVSV puts marketable PPE in the United States of America, Canada, Australia or Japan into the focus of interest. The marketability of this PPE is controlled by the responsible market surveillance authority in accordance with Sec. 24 Para. 1 ProdSG, Sec. 9 Para. 1 MedBVSV.
Other PPE can obtain the status of marketability in Germany by way of Sec. 9 Para. 2 MedBVSV. According to this, it is essential that “in an assessment procedure by a suitable body on the basis of a test principle published by the Central Office of the Federal States for Safety Technology [Zentralstelle der Länder für Sicherheitstechnik; ZLS] on its website, it has been established that they offer a level of health and safety comparable to the basic health and safety requirements according to Annex II of Regulation (EU) 2016/425“, Sec. 9 Para. 2 1st sentence MedBVSV. In contrast to the draft of 06.04.2020, this no longer refers to a specifically notified body. This means that the six recognised test centres currently in existence will continue to be able to test on the basis of the Testing principle for Corona SARS-CoV-2 pandemic respiratory masks Rev. 1 of 26.03.2020 developed by the Institute for Occupational Safety and Health of the DGUV (IFA) and DEKRA Testing and Certification GmbH, although the six recognised test centers are not all notified bodies.
These masks are the so-called corona masks or CPA. Again, the marketability is checked by the responsible market surveillance authority according to Sec. 24 Para. 1 ProdSG, Sec. 9 Para. 2 2nd sentence MedBVSV. PPE which is marketable according to Sec. 9 Para. 2 2nd sentence MedBVSV must again be “provided by the competent market surveillance authority with a confirmation, which must be enclosed with each delivery unit and provides information” that it is not PPE according to the PPE -Directive, Sec. 9 Para. 3 MedBVSV. As far as the above-mentioned delivery units are concerned, pragmatic solutions are likely to prevail in practice, even with the blessing of the market surveillance authorities. Corresponding statements from market surveillance authorities can in any case be heard “off the record”. The ZLS points out that the procedure pursuant to Sec. 9 Para. 2 MedBVSV does not replace a conformity assessment under Regulation (EU) 2016/425, so that these PPE tested in the accelerated procedure may not bear the CE mark.
In conclusion, it remains the case that PPE in the sense of Sec. 9 Paras. 1 and 2 MedBVSV, which is considered marketable by the responsible market surveillance authority in accordance with Sec. 24 Para. 1 ProdSG, is “selected by the employer and made available to the employees”, Sec. 9 Para. 4 MedBVSV, in contrast to Sec. 2 Para. 1 No. 1 PSA-BV.
Conclusion: With the entry into force of the MedBVSV, the previous status of (national) tolerance of simplified marketability of PPE in general and of self-protective masks (FFP masks and CPA) in particular is legally secured. The entry into force of the MedBVSV is thus to be welcomed without reservation, even though further legal questions will have to be answered, in particular those relating to the definition of the legal concept of the delivery unit. Furthermore, it should be pointed out that any restrictions on dispensing, e.g. only to healthcare workers, have definitely not been included in the MedBVSV.
Link to the document: Medizinischer Bedarf Versorgungssicherstellungsverordnung – MedBVSV
For further information: Schucht, NJW 2020, 1551 ff.
Do you have any questions about this news or would you like to discuss the news with the author? You are welcome to contact: Dr. Carsten Schucht