Out-Law News | 04 Sep 2019 | 2:45 pm | 3 min. read
One of the main changes proposed is a move to strengthen the existing powers of the Federal Institute for Drugs and Medical Devices (BfArM) to intervene in cases where it has concerns about risks medical devices on the market pose to patient safety.
Currently the power to require medical device manufacturers to remove their products from the market in Germany rests with state authorities in the country. The BfArM advises those authorities on the action to take but cannot compel the state bodies to prohibit the use of devices it considers dangerous or defective.
The draft legislation, which was reportedly presented to German government departments earlier this summer, would centralise the powers to prohibit the use of certain medical devices in Germany with the BfArM.
The proposed new medical devices laws in Germany must work in tandem with the two EU regulations on medical devices that were finalised in 2017, said specialists in life sciences Marc L. Holtorf and Dr. Julia Traumann of Pinsent Masons, the law firm behind Out-Law.
The Medical Devices Regulation (MDR) will take effect from 26 May 2020, while the In-Vitro Diagnostic Devices Regulation (IVDR) will take effect from 26 May 2022. Both regulations will directly apply in EU countries and do not need to be implemented into national laws.
"Germany's plan to impose further rules and regulations on manufacturers of medical devices is a critical issue," said Holtorf and Traumann. "The new European legal framework should remain as uniform and consistent as possible, and the EU member states should not create their own rules. However, it seems reasonable to centralise the monitoring of products such as artificial knees or hip joints, cardiac pacemakers and surgical instruments on the federal level as it is already the case with regard to the risk assessment."
Like existing rules, there is no formal system for pre-market authorisation of medical devices envisaged under the new EU regulations. However, medical devices would have to establish an evolving 'quality management system' to ensure compliance.
The quality management system must include, among other things, "a strategy for regulatory compliance" and a 'clinical evaluation' for each device, which medical device manufacturers are obliged to carry out to demonstrate their compliance with set safety and performance requirements.
A clinical evaluation is defined as a "systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer".
Medical device manufacturers must also designate "at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices". That person must be either formally qualified or professionally experienced for the role.
For traceability purposes, most medical devices will have to have unique identifiers. Those details will be recorded in an EU database.
Medical device manufacturers must continue to make an EU declaration of conformity for their devices, and most of the products must bear a 'CE' marking to certify that compliance.
As part of their quality management system, manufacturers must also establish a 'post-market surveillance system' (PMSS) which should be "proportionate to the risk class and the type of the device in question", according to the Council proposals.
The PMSS is designed to ensure that any problems identified in the use of medical devices are noted by the manufacturers to prevent future faults or ensure corrective action, as well as "serve the purpose of transparency".
Holtorf and Traumann said that even though the MDR and the IVDR do not need to be implemented into national laws, German minister of health Jens Spahn has previously highlighted that extensive changes to Germany's national medical device law will be necessary to account for the new EU regulations and avoid duplication and contradictory provisions.
In addition, the EU regulations mandate each EU member state to act to implement certain aspects of the new rules, and further provide flexibility to those countries to supplement the EU regulations in other areas if they wish to do so. This is a further factor in Spahn bringing forward his proposals for reform, they said.
To inform the proposals for reform, Germany's Federal Ministry of Health has brought together a variety of stakeholders to debate the way forward through a national working group for the implementation of the MDR and IVDR.
Members of the working group include a variety of government departments, including the Ministry of Health, other federal authorities, including BfArM, the Paul Ehrlich Institute (PEI) and German Institute for Medical Documentation and Information. A number of state authorities, the central authority of the states for health protection with regard to medicinal products and medical devices (ZLG) and industry representatives, including the Federal Association of Pharmaceutical Wholesalers, are also represented.
There are seven subgroups to the working group, each focusing on individual areas of medical device regulation, such as manufacturer obligations and market surveillance.
According to the Ministry of Health (BMG), the objective of the working group and its sub-groups is to identify problems related to the implementation of the MDR and the IVDR and to develop corresponding solutions. In many cases, the problems relate to the interpretation of the MDR and the IVDR, and the BMG strives to achieve a common understanding as far as possible. Since most questions must be clarified at European level, the BMG, BfArM, PEI and ZLG will share their proposals with sister bodies across the EU through European working groups.
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