A new exclusive report by 9to5Mac suggests that it may take longer than many users hope for the new ECG feature on the Apple Watch Series 4 to arrive in the U.K. While Apple pursued U.S. Food and Drug Administration (FDA) approval before announcing the Apple Watch Series 4 earlier this month, the company is reportedly still in discussions with health regulators in numerous other countries, leaving some uncertainty when — or if — the feature will ever expand beyond the borders of the U.S. 9to5Mac’s Ben Lovejoy spoke with the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) on what the process would be for the Apple Watch to gain such approvals in that country, and while he discovered that the basic process itself isn’t particularly complicated, and in fact seems similar to that followed by the FDA, Apple could also be asked to conduct a “clinical investigation,” which would be a more in-depth medical study designed to test the effectiveness of the feature.
To complicate matters further, the MHRA would likely not be satisfied with the study that Apple has already done, Lovejoy notes, since the MHRA requires that companies notify them in advance of their intention to carry out such a study, providing at least 60 days’ notice. The study must then be approved by the MHRA before it begins, and the process can be delayed further if the MHRA raises any questions. Apple must then actually carry out the study, which the MHRA says could “potentially add years” onto the process. However, Lovejoy does note that since the U.K. is still part of the European Union, Apple could obtain permission from the relevant agency in any other European country, which would satisfy the U.K. agency under EU regulations, although it remains unclear what process, if any, Apple is currently following for European certification.