EU framework conditions
Two Regulations, the MDR and IVDR, will soon replace the EU Directives currently in effect for medical devices and in-vitro diagnostics. As EU law, they will be applied directly in the member states and do not require explicit implementation into national law.
Medical Devices Act on its way out, Medical Devices Implementing Act on its way in
Accordingly, the German Medical Devices Act, which remains in effect, is no longer necessary as the implementing statute for the Directives, as currently amended. It will be replaced by the Medical Devices Implementing Act, which will establish binding rules for manufacturers and operators of medical devices in Germany, as well as for other economic operators. It includes provisions which have to be enacted in national legislation, and not in an EU Regulation. This is particularly the case for penalties (prison sentences and fines), provisions concerning the jurisdiction of national authorities and other areas where specific national legislation is required. However, the latter provisions must not conflict with the provisions of the MDR and IVDR or have the effect of hindering competition. The Medical Devices Implementing Act forms part of the “Medical Devices EU Adjustment Act” and has existed in the form of a departmental bill (PDF) since 25 August 2019.
Safety officer and medical devices advisor
Unlike the Medical Devices Act, the Medical Devices Implementing Act no longer requires a safety officer. In the future, manufacturers will be required to communicate “safety corrective actions,” but there is no longer any need to expressly appoint an inhouse safety officer for this purpose. The tasks of the “person responsible for regulatory compliance” at the manufacturer in accordance with Article 15 of the MDR do not include the duties of the safety officer as currently understood in German law. The situation is otherwise with the “figure” of the medical devices advisor, which is retained in the Medical Devices Implementing Act. The requirements for expertise in the subject and the product have also been retained.
Clinical evaluations and performance evaluations
The MDR and IVDR focus in particular on the conduct of clinical investigations and impose stricter requirements for clinical investigations than in the Directives. This circumstance is accounted for in the Medical Devices Implementing Act, which dictates the conditions for clinical investigations at length, from the application procedure through conduct of the trials and monitoring. In fact, the Medical Devices Implementing Act actually goes beyond the requirements in the MDR. For example, the Medical Devices Implementing Act requires manufacturers to obtain approval from the supreme federal authority before launching a clinical investigation even for less-than-critical products. The requirements for clinical investigations whose subjects require special protection, the guidelines for cooperation with the ethics committee and the requirements for the protection of personal data collected in clinical investigations are also more detailed in the Medical Devices Implementing Act than in the MDR.
There are also other provisions of the Medical Devices Implementing Act which go beyond the requirements of the MDR. For example, there is a registration requirement for companies engaged in the sterilization or near-sterilization of medical devices and for manufacturers of Class III implantable custom-made devices. The language requirement is unsurprising: accompanying materials for medical devices must be in German. Exceptions may only be made in individual cases, and only for professional users.
The familiar penalty scale from the Medical Devices Act, calling for prison sentences of 3 and 5 years, remains unchanged. However, additional offenses have been included in the Medical Devices Implementing Act. For example, commencing or conducting clinical investigations/performance evaluations which conflict with the requirements of the MDR/IVDR, marketing products which are not properly registered and affixing misleading statements to the product and/or accompanying materials have been newly included or redefined as offenses for which penalties may be imposed.
Manufacturers would be well-advised to acquaint themselves with the content of the Medical Devices Implementing Act, especially companies planning on marketing their products in Germany or conducting clinical investigations/performance evaluations or product sterilizations in Germany as a service provider. Both the MDR and the Medical Devices Implementing Act apply in Germany!
In particular, manufacturers should examine their existing operating procedures and revise them if necessary. Particular attention should be paid to the provisions of the Medical Devices Implementing Act with regard to clinical investigations, registration requirements and vigilance, which are more detailed than those of the MDR. Adherence to the MDR’s requirements alone is not enough: it is also necessary to comply with the Medical Devices Implementing Act.