Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and December 2022. The results revealed poor performance among manufacturers, with 70% of post-market surveillance (PMS) documentation failing to meet legal standards!
Furthermore, 14% of the manufacturers were not registered with Swissmedic, 39% of verified Class I devices were not notified correctly and 11% were unable to demonstrate compliance with new legal requirements.
Swiss Medtech urges all Class I medical device manufacturers to promptly assess and correct any compliance issues to comply with legal requirements.
Here you can find the full report.
According to the report, Swissmedic has initiated a focus campaign to assess the implementation of the new regulation for class I devices, which are not monitored by a Notified Body. Similar campaigns are also expected in the EU, as outlined in section 3 of the MDR, which details the market surveillance requirements for the Competent Authorities. Article 93 states:
- The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices …
- The competent authorities shall draw up annual surveillance activity plans …
It is important to note that the surveillance activities of Swissmedic and other EU authorities will not be limited to risk class I devices/manufacturers. MDSS anticipates that such investigations will continue in the coming years as manufacturers adjust to the new regulation. Therefore, the Swissmedic investigation in 2023 should come as no surprise, especially for class I products that should have been complying since May 2021.