Medical devices have become increasingly important in healthcare and are subject to ever more complex legal regulations. Setterwalls’ Life Sciences team has many years of experience in the medtech industry and can assist in any type of issue that may arise – from regulatory or contract law issues to strategic considerations regarding intellectual property protection.
Medical devices are used by consumers or in healthcare and include everything from patches to advanced surgical robots. In order for a product to qualify as a medical device, its manufacturer must specify a purpose and area of use for the product covered by the definition of a medical device, such as diagnosis, prevention, monitoring, treatment or alleviation of disease. However, the product does not achieve its primary intended action by pharmacological, immunological or metabolic means, as is the case with pharmaceuticals.
Medical devices are divided into different classes/groups. The classification reflects the risks associated with the products and Setterwalls has experience from this assessment. The classification controls, among other things, which procedures the manufacturer must apply to demonstrate that the products comply with the regulatory requirements.
The regulatory framework also impose strict requirements on labeling and safety in particular. Manufacturers of medical device products must be able to demonstrate safety and performance, and any risks and side effects must be described and minimized. The manufacturer of medical devices has a responsibility throughout the life cycle of the product. Information on, for example, use, risks and the like must be provided as well as any accidents or incidents reported. Setterwalls can assist with this.
Just as for medicines, medical device operators are also covered by a self-regulating ethical regulatory framework. In the same way as for the pharmaceutical industry, the regulations include cooperation and collaboration between medtech companies and the healthcare sector. Procurement law issues are also becoming increasingly common.
Setterwalls has many years of experience and can assist in all legal issues related to medical devices, whether it is classification, intellectual property issues, procurement law issues, labeling of the product or questions related to agreements, marketing or collaboration with the healthcare sector.