Between August and December 2022, Swissmedic reviewed declarations of conformity, evidence that Swissmedic had been notified of the devices, and post-market surveillance plans and reports in a random sample of 27 manufacturers (approximately 8% of all Swiss manufacturers identified at the time the data analysis was conducted) to investigate how the new regulation was being implemented regarding otherwise unmonitored devices.
As work progressed, it became apparent that 14% of the manufacturers in the sample were not registered with Swissmedic when the review took place. Initially, it was found that Swissmedic had not been correctly notified of 39% of the Class I medical devices reviewed. The outstanding and incorrect manufacturer and device registrations / notifications were dealt with during the review.
Overall, 70% of the post-market surveillance documentation reviewed, failed to meet legal requirements.
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