The EU’s new in vitro diagnostics (IVDR) and medical devices (MDR) regulations represent a major change to the regulatory landscape. They will impact authorities and Notified Bodies, as well as hospitals, laboratories and patients. Unless national governments and the European Commission invest in the necessary regulatory infrastructure, they will not be ready to properly implement these rules on time. This has serious implications.
The medical technology sector employs more than 650,000 people in 26,000 companies across Europe, all working to improve health and transform lives. Medical technologies are essential - we are talking about hip replacements, heart and brain stimulators and hospital beds, as well as tests for HIV, cancer and blood bank screening.
There are three reasons why we are concerned: the challenges facing Notified Bodies that approve new products, the lack of clarity over governance and tight transition times.
One of the largest changes is a requirement for Notified Bodies to oversee almost all IVDs - tens of thousands of products. This will mean an increase in workload of more than 780 percent. They will also need to review several hundred thousand diverse medical technologies within the next two-to-four years.
Not only will Notified Bodies need more people, they will need a huge influx of expertise and time to train new staff. Our concern is that Notified Bodies may not be available early enough in the transition period and that it may take too long to ramp up the needed capacity and experts to review the many products out there.
National competent authorities, designating authorities and agencies also need to invest in people, IT systems and infrastructure to match their expanded role. The Commission itself has only eight core people actively working on this major regulatory revamp.
For the system to work, authorities need to dedicate experts who can support implementation of each regulation - the IVDR as well as the MDR. Clarity over who will draft the guidance documents is needed. We believe the Commission is best placed to publish guidance, as they have done in the past under the medical devices directives.
The clock is ticking. The MDR applies from May 2020 and the IVDR from May 2022. Some sources suggest it could take 18 months or longer for Notified Bodies to receive their license to operate under the new legislation.
If there are then delays in the product review/approval stage, the transition times begin to look impossibly short. The prospect of a hard stop in the approval of existing and new technologies is all too real. Put yourself in the place of a business leader with a small portfolio of diagnostic tests and a new one in development.
Not only may they be unable to launch the new test, they may also be unable to continue providing existing ones. MEPs can help by raising awareness of these challenges at national level and encourage the Commission to put in place the resources needed to make these new regulations work. With political will, a healthcare crisis can be averted.