From May 20, 2020 on, two new pieces of law will apply to medical device manufacturers:
- The Medical Devices Adaptation Act-EU (MPAnpG-EU), which was adopted in a modified version on March 5, 2020 by the German Bundestag as a draft law, as well as
- The Medical Devices Implementation Act (MPDG).
The Medical Devices Implementation Act (MPDG) will replace the Medical Devices Act (MPG). It is interesting for manufacturers of IVDs that the MPDG initially only applies to products (i.e. medical devices) that are subject to Regulation (EU) 2017/745. Initially, the in vitro diagnostic medical devices within the meaning of Regulation (EU) 2017/746 are not covered. For these products, the MPG in the current version continues to be applicable until the beginning of the application of Regulation (EU) 2017/746 on May 26, 2022.
Even if the MDR already is a fully applicable legislation and, like all EU regulations, does not need to be transposed into national law, national regulations are required, e.g. to define which authorities are responsible in the respective country, fix penalties such as prison terms and fines or describe specific national requirements or regulations. This includes e.g. the regulation of whether reprocessed medical devices are allowed to be placed on a national market in the respective EU country.
What is changing specifically with the MPDG?
The MDR and IVDR already provide the legal framework. In contrast to the MPG, the MPDG therefore no longer contains many stipulations such as the conformity assessment procedure. The duration for prison sentence (3-5 years) remains unchanged, but the law defines additional criminal offenses, e.g. placing counterfeit products on the market. This is particularly precarious, since a person who places counterfeit products on the market is generally accused of criminal commercial trade violations, which can result in up to 5 years imprisonment. The non-MDR-compliant start or continuation of clinical trials can be punished with imprisonment. The same is applicable for the placing on the market of medical devices without having registered them or not having registered the legal manufacturer. Also punishable is providing misleading information on the product, the packaging, the instructions for use or in advertising materials.
This requires special attention on the part of the manufacturers when creating and approving advertising materials. The MPDG has also expanded the catalog of fines, but fines remain at a maximum of EUR 30,000. De facto, the “person responsible for regulatory compliance” takes on the tasks of the safety officer, but at the same time inherits many more responsibilities. However, there will still be medical device consultants (Medizinprodukteberater) in Germany who have to demonstrate appropriate expertise. Requirements for the application, implementation and monitoring of clinical studies are regulated in detail and partly go beyond the requirements of the MDR. A significant change in the competence of the authorities results from the fact that in future the Federal Authorities (and not the state authorities) will be responsible for taking protective measures against unacceptable risks. Ordering a recall, prohibiting sales or sending Field Safety Notices to the public will therefore probably be carried out directly by the BfArM in the future. The MPDG contains requirements that go beyond the requirements of the MDR in the following areas:
Clinical trials: The requirements for clinical trials must also be met if these studies do not serve to demonstrate the benefits, safety and performance of the products, but rather new scientific knowledge. The MPDG obliges manufacturers to not start clinical trials, even with less critical products, without prior approval by the higher Federal Authorities.
It also raises the bar for clinical trials on special subjects (minors, prisoners, etc.). Additionally the law describes the interaction with the ethics committee and its procedure in more detail. Personal data collected during clinical trials must be pseudonymized by the investigator before submission. The law contains an obligation to register with the authorities for companies that sterilize medical devices or companies that perform low-germ processing of medical devices. This also applies to companies that manufacture implantable custom-made products of class III.
Language requirement and labeling: Information supplied with the product (labeling) must be written in German. Exceptions apply to products that are intended for professional use. Devices for demonstration purpose must be explicitly labeled (at least if they do not meet the requirements of the regulations).
Uncertainties regarding classification: In the event of a dispute about the classification between the manufacturer and the Notified Body, the higher Federal Authority decides.
Measures on the part of the authority: Section 74 of the MPDG obliges the authorities to act when an Economic Operator is inactive. Due to a lack of definition, it remains unclear how quickly an Economic Operator has to act.
Handling of the MPDG by the manufacturer
It is strongly recommended that companies that manufacture or market medical devices in Germany, companies that conduct clinical trials or that act as sterilization service providers study the MPDG in detail. Unfortunately, there is currently still no consolidated catalog of requirements. MDR compliance alone is not sufficient. Manufacturers cannot avoid checking their procedural instructions and adapting them to the requirements of the MPDG if necessary. To do this, a gap analysis is an essential initial step.
Manufacturers and distributors of medical devices in Germany, but also those who conduct clinical studies and provide sterilization services cannot avoid studying the MPDG. Pure compliance with the MDR is not sufficient. Processes must also be checked for conformity with the MPDG after modification to the requirements of the MDR and modified if necessary.