Compliance with the new MDR/IVDR regulation might cause affected companies additional work. It is crucial to evaluate your product portfolio based on the new regulations and conduct a risk and priority assessment. You will also need to look into the process for device registration and approval, the coordination and communication with the regulatory bodies.
Given the three and five-year transitional periods and the technical as well as organizational efforts, it is crucial to start this journey to compliance as early as possible. It is best to start the process with a sparring partner that is knowledgeable and who has already registered products with various authorities in order not to leave out any important detail.
Regulatory improvements always come with a price tag. In the case of the new MDR/IVDR regulations it is quite hefty as it brings fundamental changes. It will most certainly also increase the already high healthcare costs. It is difficult to predict how this will affect Switzerland’s medtech industry. What is quite sure already now is that it will inflict additional pressure on budgets, margins and the entire business planning in life sciences.
Factsheet: Are you ready for EU MDR? (PDF)