Swissmedic Announces Random Sampling
The Swiss Agency for Therapeutic Products Swissmedic announced on 23 April in a letter to manufacturers and authorised representatives of medical devices, that the supervisory and regulatory authority would be carrying out targeted spot checks in the coming months in order to fulfil its supervisory duties.
Look Closely
It is therefore advisable for manufacturers of medical devices of any risk class to take another close look: Do your PMS systems meet the requirements of the Swiss Medical Devices Ordinance (MepV)?
This includes not only the monitoring mechanisms that have actually been implemented, but also the coordinated plans in which these mechanisms, potential scenarios and risks are systematically recorded, analysed and assessed using decision matrices.
Better Safe Than Sorry
If the Swissmedic auditors identify non-compliant issues, this can prove costly for manufacturers: from expensive, urgent corrective measures and sales suspensions to hefty fines – and all potentially due to a mistake that could easily have been avoided.
In the latest Swissmedic 2024 priority campaign focusing on post-market surveillance, non-conformity findings were identified in 20 out of 30 cases. That is two-thirds of all manufacturers audited!
On the one hand, these statistics speak volumes about how complex and demanding the regulatory requirements are; on the other hand, they also highlight the significant gap between many manufacturers’ self-assessment and the findings of the auditors.
So it’s better to check once too often than once too little!
On the Safe Side
The advice from regulatory experts is therefore: check everything carefully first, then sit back and relax.
Our partners at Albo-Healthcare GmbH specialise in Swiss regulatory requirements and can, upon request, provide medical device manufacturers with a detailed assessment of their regulatory compliance, including plans and tools for improvement.
Contact us at BEO BERLIN or get in touch directly with our colleagues in Switzerland.
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