In the event of a free trade agreement with the EU, the UK will continue to be bound by current EU laws, thereby adhering to the new Medical Device Regulation (MDR). This will significantly change the landscape of the medical device industry, says GlobalData, a leading data and analytics company.
According to GlobalData estimates, there are over 20,000 medical devices currently in the pipeline globally, with almost half in the early stages of development. Approximately 15.2% 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, Medical Devices Analyst at GlobalData, comments: “The EU’s MDR will negatively impact the number of pipeline products approved in the UK. 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 continues: “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.”