Between Between August and December 2022, Swissmedic launched a focus campaign to investigate how the new regulation was being implemented with regard to Class I Medical devices.
It reviewed declarations of conformity, evidence that Swissmedic had been notified of the devices, and post-market surveillance plans reports in a random sample of 27 manufacturers (approximately 8% of all Swiss manufacturers identified at the time the data analysis was
conducted).
Their findings are as follows:
- Manufacturers not registered with Swissmedic or Swissmedic not correctly notified
- 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.
- Declarations of conformity
- 11% of the manufacturers whose declarations of conformity were reviewed were unable to demonstrate fulfilment of the new legal requirements (no declaration of conformity in accordance with MedDO/EU MDR).
- Without this proof, however, devices may not be placed on the Swiss market. Swissmedic notified the manufacturers of corresponding measures, as a result of which the majority of manufacturers subsequently submitted confirmation of compliance with the new requirements.
- Manufacturers who did not provide confirmation were prohibited from placing the devices in question on the market.
- Post-market surveillance documentation review
- Overall, 70% of the post-market surveillance documentation reviewed failed to meet legal requirements.
- As a result, manufacturers were unable to demonstrate continuous and systematic surveillance of their devices on the market.
- The majority of these deviations from legal requirements (non-conformities) concerned data collection and the evaluation of (serious) incidents and trends.
- As part of the review procedure, manufacturers were given the opportunity to rectify the deficiencies identified within a specified deadline.
- Swissmedic will continue to review manufacturers’ updated documentation and monitor the corrective actions.
- If the deviations are not rectified, Swissmedic will impose additional measures.
What does the inspection/review demonstrate?
The review demonstrates that:
- manufacturers of Class I medical devices are not adequately implementing the Medical Devices Ordinance, despite it having been in force for 18 months.
- This applies particularly to post-market surveillance.
What did the focus campaign succeed in doing?
The focus campaign succeeded in obtaining corrective actions from the affected manufacturers and in making the market as a whole aware of the implementation of the new requirements
On swissdamed
The Swiss Database on Medical Devices – swissdamed – which is currently being developed, will increase transparency as regards the devices on the Swiss market and give Swissmedic a data resource for more comprehensive, wider-ranging controls.
Source: Swissmedic