The Danish Parliament has passed a new act introducing, among other things, rules on the provision of implant cards to patients. The rules will apply as from 26 May 2021.
The new Act on research ethics treatment of clinical trials of medical devices, etc., introduces new obligations regarding the provision of implant cards. The object of the new obligations is to align Danish legislation with new EU rules.
EU Regulations on medical devices
The EU directives on medical devices will be replaced by Regulation (EU) 2017/745 on medical devices (MDR) on 26 May 2021 and Regulation (EU) 2017/746 on medical devices for in vitro diagnostics (IVDR) on 26 May 2022. The MDR contains rules on implant cards and information, which the manufacturer must provide together with implantable medical devices. This concerns in particular information making it possible to identify the device, warnings and other precautions to be observed by the patient or health care professionals, information about the expected useful life of the device as well as other information ensuring that the device is used in a safe manner.
The MDR defines an implantable device as any device, including those that are partially or wholly absorbed, which is intended (i) to be totally introduced into the human body, or (ii) to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days must also be deemed to be an implantable device. A number of implants are exempted from the rules on implant cards and related information, including sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
Furthermore, an obligation is imposed on Member States to require that health institutions make the implant cards and the related information available to the patient.
With the provision of an implant card, patients as well as health care professionals will be able to quickly identify the implant in order to take this into account in connection with subsequent examinations and treatment of the patient. The patient will also have access to updated information to ensure that the device is used in the best way possible.
Danish practice so far
Currently applicable Danish law does not contain rules stipulating that manufacturers must provide an implant card together with an implant. Consequently, there are in addition no rules imposing on healthcare providers an obligation to provide an implant card to patients having received an implant.
New requirement for the provision of implant cards
In order to be able to meet the new requirements in the regulation on medical devices, a provision is now incorporated into the Danish Act on Medical Devices according to which Danish health institutions must make implant cards and the information following from the regulation available to the patients having received implants.
This means that both manufacturers and health institutions, such as clinics and hospitals – public and private – must ensure compliance with the new rules. For manufacturers in particular, this will mean new obligations in continuation of the obligations on information, labelling, etc.
For more details on the statutory amendments, click here.