Following the EU regulation updates, the German legislator amended regulations relating to medical products to better align with the changing market. Existing databases were also updated so authorities and consumers could utilize information channels faster and more efficiently.
Effective July 29, 2014, the following are legal changes enforced in Germany regarding medical devices:
- German decrees on sales channels for medical products (MPVertrV) and prescription requirements for medical products (MPVerschrV) have been merged to create one strong regulatory framework. As a result of this merger, prerequisites are now enforced concerning storage. The requirement discusses how storage must be executed in such a way to ensure quality maintenance. In addition, the dispensing of in vitro diagnostics (IVDs) equipment for confirming pathogens of a certain infectious diseases is limited to doctors, medical laboratories and other inpatient and outpatient facilities within the healthcare system. For self-test IVD, professional consultation is to be provided as needed.
- The German decree on medical product safety planning (MPSV) explains that the tester of the medical device is only required to report serious adverse events to the sponsor, and it is the sponsor’s responsibility to report the event to the proper authority. If a medical device and/or sample material is suspected of involvement in an incident, it is the tester, user and operators responsibility to ensure that they are not discarded until the investigations are finalized. Additionally, specific reports and notifications stated in MPSV now include serious adverse events that may be connected to clinical trials.
- The German decree on medical product clinical trials (MPKPV) defines the necessity for pre-clinical evaluation with underlying scientific knowledge to be included with any application to conduct clinical trials.
- The German DIMDI (German Institute of Medical Documentation and Information) decree (DIMDIV) now includes briefings and has modified the data storage period. The decree also gives notified bodies access to falsified certifications as well as the incident database (limited to products notified bodies have issued a certification for), and ethics committees access to relevant serious adverse events reports.
The following are legal changes regarding medical devices that will come into effect on October 1, 2015 in Germany:
- The German decree on medical product operators (MPBetrV) has increased demands on the reprocessing of specific critical medical devices. For instance, the decree requires the quality management system of the reprocessor to be certified by a competent body recognized by the appropriate authority. Also, the requirements for implanting medical devices is increasing immensely. These requirements cover all implantable medical devices. Formerly, MPBetrV was limited to only “active” implants. As a result, written patient information must now be provided with all implanted medical devices, and an implant pass/implant card is to be given to the patient containing specific information about the patient and the device.
- The language is being modified in §16, paragraph 1 and 2 of MPSV to clarify the responsible parties who manage corrective measures.