Swissmedic Audit Reveals Compliance Issues with Class I Medical Device Manufacturers

Swissmedic, as expected, has started auditing and inspecting relevant economic operators. For example, Swiss-authorized representatives were subject to systematic and focused inspections in the first half of 2022, including Class I medical device manufactures regarding how the EU MDR as well as MedDo requirements were being implemented.

Swissmedic identifies compliance issues with Class I medical device manufacturers

We anticipate that inspections and audits will increase in frequency in the coming months and years, and most recently this impacted Swiss manufacturers of Class I self-certified medical devices. Between August and December 2022, Swissmedic launched a campaign to investigate how the EU MDR as well as Swiss MedDO requirements were being implemented by these manufacturers. As these devices are otherwise not assessed by independent bodies, the inspections shed some light on areas where manufacturers may improve their level of compliance. 

Manufacturers of Class I medical devices not meeting post-market surveillance requirements

The review demonstrates that manufacturers of Class I medical devices are not adequately implementing the new regulatory requirements, despite them having been in force for 18 months. This applies particularly to post-market surveillance (PMS). Fulfilling PMS obligations is an essential aspect of the new regulations, which require this to be done consistently and systematically throughout the life cycle of the devices concerned. The goal is to ensure and enhance patient safety. Manufacturers are obliged to prepare a PMS Plan as well as a PMS Report, and these documents ought to also align with the manufacturer’s internal procedures for PMS. These documents will, in particular, be scrutinized during any review of Technical Documentation. In many cases, non-conformities were related to data collection and the way manufacturers evaluate and respond to field-safety incidents and trends.  

In addition, Swissmedic identified that a considerable percentage of Class I medical device manufacturers were not able to produce Declarations of Conformity which reflect the updated requirements. Here are some quick numbers… 

27 Swiss class I medical device manufacturers were randomly inspected by Swissmedic:  

• • 11% of the products did not have proof of compliance with the new requirements and therefore could not be marketed, or had to be taken off the market; 
  • 39% of the devices and 14% of the manufacturers were not correctly registered with Swissmedic; and 
  • 70% of the documentation on surveillance of the devices on the market did not meet the new requirements. 

Swissmedic, at this time, has no reason to believe that the situation at foreign manufacturers is fundamentally different, and so will continue to monitor this if necessary. MedEnvoy, in our reviews of the Technical Documentation for device manufacturers, concurs with this view and we often identify areas where compliance can be improved. 

We are here to assist with any questions you may have. If you are looking for more specific guidance on meeting new requirements, for example in terms of your PMS obligations, do not hesitate to get in touch.