Swissmedic announces random spot checks on importers – BEO BERLIN recommends seamless documentation and proactive compliance management.
The Swiss Medical Devices Authority has announced that it intends to conduct random tests on individual importers who import medical devices into Switzerland with immediate effect. The aim of this measure is to ensure regulatory compliance against the backdrop of a number of revisions to Swiss regulatory practices.
Swissmedic reports that random spot checks will be carried out on site following written notification. In view of these circumstances, BEO BERLIN recommends that all importers review their processes and documentation and, if necessary, consult professional partners to avoid disruptions in the supply chain.
Background: Regulatory Provisions are Expiring
Some transitional regulations for old products expired on 26 September 2024. While exemptions allow some products to continue to be sold under the old regulations until 2027 or 2028, other products must be withdrawn from the market immediately or re-evaluated. In short, this is a process that cannot be handled in a blanket manner, but requires a large number of individual assessments. For this reason, Swissmedic is now specifically checking individual importers and products for compliance.
Biggest Problem: Incomplete Documentation
According to Swissmedic, the most common problem for importers and manufacturers is that the technical documentation for products is incomplete with regard to the new regulations. Naturally, manufacturers and importers who have been working with the now expired regulations for many years may not be immediately aware of new requirements or assessment categories, and a meticulous examination of the highly detailed documents is very time-consuming.
Swissmedic clearly assigns responsibility for testing products in accordance with the provisions of the EU MDR to manufacturers and importers:
„If you, as an importer, believe or have reason to believe that a product does not comply with the requirements, you must not place the product on the market until it has been brought into conformity.“.
If importers fail to comply with this obligation, whether intentionally or through ignorance, they risk legal consequences, including import bans on their products.
What Manufacturers and Importers Should do Now
Swissmedic expects complete documentation. In order to be able to present this in the event of an inspection, importers and manufacturers should not wait until the last minute, but should act proactively. BEO BERLIN recommends:
- Review your portfolio and determine which products are subject to the phase-out regulation.
- Make sure that
- A manufacturer's declaration is available and
- confirmation has been received from the notified body.
- Put the collected documents together and keep them ready for a Swissmedic spot check.
Expert support? BEO BERLIN!
As an experienced company in the field of regulatory compliance, BEO BERLIN is your ideal partner to assist you with the tasks mentioned above.
We work with you to develop comprehensive technical documentation, ensure quality management systems and organise your regulatory compliance in a cooperative and pragmatic manner.
For 25 years, we have been helping manufacturers and importers of medical devices navigate safely through all regulatory bottlenecks and rapids. Professionally and internationally. So that your products reach the market safely. Contact us!
