Goodbye to the Medical Devices Act, and hello to the Implementing Act for Medical Device
The current Directives for medical devices and in-vitro diagnostics will be replaced in the future by two EU Regulations, Regulation (EU) 2017/745 on medical devices (the Medical Device Regulation, MDR) and Regulation (EU) 2017/746 on invitro diagnostic medical devices (the In-Vitro Diagnostics Regulation, IVDR) (PDF) . The entry into force of the MDR was postponed by one year due to outbreak of the coronavirus pandemic, to 26 May 2021. The IVDR will take effect on 26 May 2022. Once the two Regulations take effect, there will be no need to implement them into national law, so that the German Medical Devices Act (only in German) will no longer be valid in its current form. Once the MDR takes effect, it will be replaced by the Implementing Act for Medical Devices Law. In accordance with § 2 of the Implementing Act, the Act applies to devices within the scope of Regulation (EU) 2017/745. The Medical Devices Act as amended as of 25 May 2021 will continue to apply for in-vitro diagnostics up to and including 25 May 2022. It will also be necessary to make additional changes to Germany's national laws concerning medical devices.
Future national regulations
The new Ordinance on the reporting of suspected serious adverse incidents involving medical devices and on the exchange of information by the competent authorities (the Medical Device User Reporting and Notification Ordinance (MPAMIV) (PDF) serves to implement the MDR and the IVDR and regulates the reporting of suspected serious adverse incidents. When it takes effect, the Ordinance will replace the Medical Device Safety Plan Ordinance and its provisions include definitions of the term "incident" and of the various spheres of responsibility and formal requirements with regard to the reporting of incidents.
Also new is the Fee Ordinance to the Implementing Act for Medical Device Law, which serves to create a schedule of fees for individually attributable public services provided by the competent federal authorities in accordance with the MDR and the Implementing Act, as well as the Ordinances issued for the implementation of that legislation.
The Medical Device Method Assessment Ordinance will have to be revised due to replacement of Directive 93/42/EEC by the MDR and changes will have to be made to the Pharmacy Operation Ordinance as a result of the replacement of the Medical Devices Act with the Implementing Act for Medical Device Law. The same applies for the Medical Device Prescription Ordinance.
Changes will also be made to the Medical Device Operator Ordinance as national law adapts to the MDR. These changes will include new provisions on the reprocessing of single-use devices in accordance with the specifications of Article 17 of the MDR and the Ordinance will also implement the requirement in Article 18(2) of the MDR for health institutions to provide patient information about implants.
Consequences of non-compliance
The Medical Device User Reporting and Notification Ordinance is directed primarily at government agencies, but also affects operators and manufacturers of medical devices and in-vitro diagnostics. The new Ordinance contains relatively few requirements which directly affect manufacturers, compared to the "old" Medical Device Safety Plan Ordinance. Nevertheless, medical device manufacturers are required to be familiar with and implement the provisions of the new Ordinance as well as those of the MDR and IVDR and the Implementing Act for Medical Device Law as part of their regulatory compliance requirements. It is also essential for manufacturers to be aware of changes in national regulations so that they can fully adhere to their requirements. Ignorance of these changes and the failure to implement the new regulations in their internal processes may be viewed as a breach of the manufacturer's duty of care and its duty to safeguard traffic, and could therefore create the risk of liability in tort in addition to the existing product liability risk.