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Swissmedic has performed inspections at class 1 manufacturers
Swissmedic inspections at Class I manufacturers have confirmed a pattern EUMEDIQ sees regularly: regulatory overload without a notified body in the picture. An explanation of the implications for onboarding and oversight.
Swissmedic has performed inspections at class 1 manufacturers within Switzerland
The result is impressive, but not surprising due to our experience as Authorised Representative in EU, Switzerland and UK. During our onboarding process EUMEDIQ, we check not only completeness of Technical Documentation of our customer, we also do a plausibility check in order to estimate our business risk. Especially, class I manufacturers without notified body need to undergo an onboarding audit in order to assess the conformance of both, product (documentation) and quality management system. And we see that these class I manufacturers are often overwhelmed with the regulatory requirements.
For our business this means that class I manufacturers impose a higher risk and workload then manufacturers monitored by an accredited Notified Body.
KEY TAKEAWAY
Class I Manufacturers Carry Higher Regulatory Risk
Swissmedic inspections of Class I manufacturers in Switzerland confirm what EUMEDIQ has observed as an Authorised Representative: Class I manufacturers operating without a notified body are frequently overwhelmed by regulatory requirements. EUMEDIQ's onboarding process therefore includes a plausibility check on technical documentation and an onboarding audit to assess product and quality management system conformance, since these manufacturers carry a higher business risk than those monitored by an accredited notified body.
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