Over the past few years, numerous M&A transactions have involved medical products law. Various small and medium-sized companies active in the sector have merged to take advantage of economies of scale and …
In the course of the spread of the COVID-19 disease, caused by the virus SARS-CoV-2, there is an increasing shortage of medical devices. There is also an acute need for newly developed medical devices, such as rapid tests. The products are subject to the provisions of the Medical Devices Directive 93/42/EEC. The regulations define the requirements for technical design, manufacture and sale.
With its recommendation (EU)2020/403 of 13 March 2020, the European Commission (EU Commission) presented measures to accelerate and simplify the procedures for the distribution of medical devices and personal protective equipment. However, a recommendation of the EU Commission is, pursuant to Article 288 TFEU, not binding, so that implementation requires corresponding national legislation.
The prerequisites for the placing on the market of medical devices are regulated in German law in the German Medical Devices Act (MPG) and the corresponding regulations to the MPG in conjunction with the relevant EU directives. According to these, a CE mark must be affixed to the product so that the product may be placed on the market. This does not apply to medical devices with a special approval pursuant to Section 11 (1) MPG and in-vitro diagnostics intended for performance evaluation purposes. Prerequisites for the CE marking are the fulfilment of the basic requirements according to Section 7 MPG and the execution of the prescribed conformity assessment procedure. The conformity assessment procedure is carried out by notified body or notified institutions.
In order to address the current high demand for appropriate medical devices and personal protective equipment (PPE), the EU Commission's recommendation provides for measures to ensure that medical devices are made available on the market more quickly. In particular, manufacturers should now be able to place products on the market in exceptional cases without the otherwise required CE marking. In the case of medical devices, member states should therefore consider allowing exceptions to the conformity assessment procedures. 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.
In Germany, the provision under Section 11 (1) MPG allows compliance with the recommendation of the EU Commission for medical devices. According to this provision, the Federal Institute for Drugs and Medical Devices (BfArM) can grant temporary special approvals for medical devices upon request for health protection purposes. In view of current events in connection with the coronavirus, the Institute for Drugs and Medical Devices believes that the granting of special approvals is in the interest of health protection. Thus the mandatory requirement of Section 11 (1) MPG is met (read here). Accordingly, special approvals can be granted for rapid tests, medical respiratory masks etc.
The application for a special approval is made informally. We recommend prior consultation with the Institute for Drugs and Medical Devices BfArM. The application must be demonstrate that the products in question meet the relevant safety and performance requirements such as those of the applicable technical standards. In the case of an application for a rapid test, the applicant must in particular prove sufficient sensitivity and specificity by appropriate documentation.
Please note that the MPG shall cease to be in effect as of 26 May 2020. It will be replaced by the Medical Devices EU Adaptation Act (MEPUAnpG) which was passed by the German Bundestag on5 March 2020 to adapt medical device law to the Medical Devices Directive (EU) 2017/745 ("MDR"). The Federal Council (Bundesrat) approved the law on 27 March 2020. In accordance with Section 7 in conjunction with Section 85 EPUAnpG, also the MEPUAnpG authorizes the Institute for Drugs and Medical Devices, BfArM, to grant special approvals for medical devices. According to the explanatory memorandum, the new Section 7 MEPUAnpG corresponds to Section 11 MPG. The link to the draft law for the MEPUAnpG can be found here. However, in view of current developments, there is a discussion at EU level to postpone the entry into force of the MDR by one year, so that the MEPUAnpG might also not come into force until 2021. The MDR is accompanied by tightening measures such as unannounced inspections and stricter tests of the notified bodies, so that the regulations would be counterproductive for facilitating the marketing of medical devices.
Due to the current amendment to the Protection Against Infection Act (IfSG), the Federal Ministry of Health is furthermore authorised pursuant to Section 5 (2) no. 4 InfSG to take measures for the distribution of medical devices by issuing statutory regulations, in particular to permit exceptions to medical device regulations governing the manufacture, marking, approval, clinical testing, use, prescription and dispensing, import and export, introduction and liability. Such measures are compatible with EU law with regard to Article 59 MDR. According to this, it may be necessary to allow exceptions in the interest of public health and in order to ensure supply. In this respect, legal regulations could be issued in a timely manner to further facilitate the placing on the market of medical devices, at least temporarily, such as exemptions from the conformity assessment procedure.
(Lawyer, Licensed Specialist for Medical Law)
(Lawyer, LL.B.)
