When the European Medical Device Regulation (EU) 2017/745 (MDR) becomes applicable from 26.05.2021, the new Medical Device Law Implementation (MPDG) will also apply in Germany, replacing the Medical Device Law (MPG). In principle, the MDR takes precedence over national legislation, but legal topics not regulated in the MDR as well as national regulations expressly required by the MDR must be implemented by the member states in laws - in Germany, the MPDG. With regard to in vitro diagnostic medical devices, it should be noted that the corresponding requirements in the MPDG will not apply until the European Regulation on In Vitro Diagnostic Medical Devices (EU) 2017/746 (IVDR) becomes applicable, namely from May 26, 2022.
Overview of the content of the law
The scope of the MPDG has grown considerably with 99 paragraphs compared to 44 paragraphs for the MPG. It is divided into 10 chapters:
- Purpose, scope and definitions
- Notification requirements, placing on the market and putting into service of devices as well as their provision on the market, other provisions
- Notified bodies, testing laboratories, conformity assessment bodies for third countries
- Clinical trials and other clinical investigations
- Vigilance and surveillance
- Medical device advisors
- Competent authorities, regulatory powers, other provisions
- Special regulations for the German Armed Forces and for civil defense and disaster control
- Penal and fine provisions
- Transitional provisions
In the following, we present some important innovations.
Important contents and innovations in detail
The legal layman may assume that chapter 1 can be safely ignored. But operators of medical devices should take a closer look. This is because § 2 (2) extends the scope of the MPDG, in addition to the actual medical devices, to products that have not been placed on the market as medical devices but are used with the intended purpose of a medical device within the meaning of Annexes 1 and 2 of the Medical Devices Operator Ordinance. Additional definitions are only found in the MPDG if they are necessary to understand the German legal requirements.
As the title of Chapter 2 makes readily apparent, a whole range of topics are covered here. The MDR contains requirements for the registration of economic operators, e.g. manufacturers, in the European database EUDAMED. In addition, the MPDG contains notification requirements for other actors such as establishments and facilities that manufacture implantable custom devices of class III (§ 4 (2)). Information from the manufacturer may now also be written in English for the German market.
Chapter 3 focuses on regulations concerning notified bodies, testing laboratories and conformity assessment bodies for third countries. The responsibility for Notified Bodies and testing laboratories remains with the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
Chapter 4 on clinical trials and other tests alone comprises 47 paragraphs. The most important changes include:
- There must first be a positive vote by the ethics committee (Section 31 MPDG) before approval of the clinical trial can be applied for from the Federal Institute for Drugs and Medical Devices (BfArM). Whether there actually has to be an approval or only the absence of an objection by the BfArM depends on the risk class of the medical device to be tested.
- The previously mentioned applications for clinical trials are to be submitted via different online portals, namely the European database EUDAMED for approval by the BfArM and the German Medical Devices Information and Database System (DMIDS) for the vote of the ethics committee.
- Article 68 MDR is an example of the need for national legislators to regulate certain legal topics in more detail. For example, Article 26 of the MPDG stipulates that, with regard to the compensation that may have to be paid by the sponsor, an insurance policy must be taken out for the subjects, and this must be done on the terms stated.
- We are often asked about the conditions for so-called other clinical trials, which do not aim at CE certification, but only serve a scientific interest. Here, § 47 MPDG is relevant, which represents the national implementation of Art. 82 MDR. In addition, sections 1 (§ 24 ff.) and 2 (§ 64 ff.) apply to other clinical trials. What is new is that for scientific studies with a non-CE-certified medical device, there is only an obligation to notify the BfArM and no obligation to obtain approval, but a positive ethical vote must nevertheless be available (§ 47 (2)). For scientific studies with a CE-certified medical device, the obligation to notify the BfArM and the vote of the ethics committee do not apply (§ 47 (3) MPDG). However, the other legal requirements apply, such as those of data protection law and the professional law of physicians, as well as the provisions of criminal law.
Many other regulations in this context continue to apply in a similar form as under the old legal framework, but the previously relevant sub-legal regulations are dropped or replaced (see below).
Chapter 5 specifies MDR requirements for vigilance and supplements the new German Medical Devices User Notification and Information Ordinance (MPAMIV) (as a replacement for the previously applicable Medical Devices Safety Plan Ordinance (MPSV)). Overall, this increases the effort for vigilance (manufacturers) and market surveillance (authorities).
The medical device advisor as a German speciality remains with chapter 6. Only the recipient of reports on problems with the use of the medical device changes from the safety officer to the responsible person (Art. 15 MDR).
The most important regulation in Chapter 7 mandates the BfArM with the establishment and operation of a central medical device information and database system (DMIDS) by December 31, 2022 at the latest (§ 86 MPDG). In this context, compatibility with EUDAMED is to be ensured.
Special regulations apply to the German Armed Forces as well as to civil defense and disaster control, which are laid down in chapter 8.
Criminal and fine provisions are always within the regulatory scope of the member states and are regulated accordingly in Chapter 9 in Germany. It should be noted here that the penalty for deprivation of liberty can now be 1-10 years.
Chapter 10 subsumes different transitional provisions for the medical device information and database system, the "old products" placed on the market in accordance with the European directives, and clinical trials.
Sublegal regulations in Germany
The Medical Devices EU Adaptation Regulation (MPEUAnpV) has not only launched the MPDG, but has also made the changes to the sub-legal regulations in Germany listed in the table below:
