Implant card vs. implant registry
The Medical Device Coordination Group (MDCG) recently published new guidelines for member states, the industry and interest groups concerning the implant card required by the MDR (Article 18 of the MDR). At the same time, Germany's Federal Cabinet adopted a bill on 3 April 2019 "to establish a German implant registry and further amend Book Five of the Social Code" (the Implant Registry Act). This law and the associated registry, set in motion by Federal Health Minister Jens Spahn, should take effect as early as 2020. The meaning and purpose of the implant card in accordance with Article 18 of the MDR depend on the individual case: it is not intended for the purpose of registration or to provide an overview of devices. The three main objectives of the implant card are:
- enabling identification of the implanted device and ensuring access to information about the device;
- enabling identification of relevant information for the patient;
- providing information about the patient.
Aside from the design of the implant card, Article 18 of the MDR also contains substantive requirements. Article 18 I a) of the MDR specifies the information which manufacturers are required provide on the implant card, including:
- the device name;
- serial number, lot number;
- unique device identification (UDI);
- name, address and website of the manufacturer; and
- the device model.
Article 18 II of the MDR is addressed to the member states and requires them to direct their health institutions to provide implant cards to the affected persons. In order to ensure standardization despite national implementation, there is to be a European or international design for the implant card. Formal requirements are also formulated. For example, the external dimensions of the implant card are to conform to those of a credit/ATM card or ID card.
The body which is primarily responsible for the implant registry is the German Institute for Medical Documentation and Information (DIMDI), which operates under the aegis of the German Health Ministry, although this task may be assigned to the Federal Institute for Drugs and Medical Devices (BfArM) in the future. The focus of the registry is on the product. DIMDI will set up and operate the registry, as well as serving as a central data repository. The primary goal of the registry is to improve patient safety and help identify risks from implantable medical devices at an early stage. But it is also designed to improve quality assurance for implants and for research purposes, as well as possibly acting as an early warning system. Key provisions of the Implant Directory Act include a provision requiring manufacturers to register their products in the product database as well as stricter transparency guidelines, e.g. through annual reports issued by DIMDI and the Federal Institute for Drugs and Medical Devices.
Summary and conclusion
The implant registry and implant card are not to be equated, but are also not entirely independent of one another. Both measures have a similar goal in mind: improving patient safety.
However, the implant card is an individual measure which is to be closely coordinated with and adapted to each specific patient and device.
The implant registry, on the other hand, is being established for the purpose of mandatory and systematic long-term observation so as to improve the quality of care received by all affected patients.
Accordingly, coordination between manufacturers of implantable devices, health institutions and the competent authorities concerning the guidelines for the implant card and implant registry is indispensable.