According to GlobalData estimates, there are more than 20,000 medical devices currently in the pipeline globally, with almost half in the early stages of development. Approximately 15.2 percent of pipeline medical devices are in Europe and will be strongly impacted by changing EU MDR and in-vitro diagnostic medical devices regulation (IVDR).
Aliyah Farouk, a medical devices analyst at GlobalData, said: “The EU’s MDR will negatively impact the number of pipeline products approved in the U.K. They will impose a greater scrutiny and stricter requirements on areas such as technical documentation and clinical evaluation, as well as enforcing stringent rules on notified bodies.”
The regulations will be in full practice following a transition period to allow manufacturers, notified bodies and authorities to comply with the changes.
Farouk continued: “Many companies are already struggling with the demands of the MDR, such as updating their IT systems and reassessing clinical trials for certain products. Failing to meet the new standards will mean delays for new device approvals. Additionally, a high proportion of pipeline products will be caught in a transitioning approval process, which could temporarily lead to a decline in the volume of approved devices. The new MDR will also affect existing devices competing with MDR complaint devices, which put safety as a priority. Therefore, one device could be seen as less safe than another, potentially resulting in an impact on hospital purchasing decisions.”
Although the United Kingdom formally left the EU on Jan. 31, the two sides are still connected, as there are months of negotiations to follow. The U.K. has agreed the terms of its EU departure, but both sides still need to decide what their future relationship will look like. This issue will need to be discussed and agreed upon during the transition period (a.k.a., the implementation period), which began immediately after Brexit day and will end Dec. 31.
During this period, the U.K. will continue to follow all of the EU's rules and its trading relationship will remain the same.