A concerned client of Advena has shared their recent audit experience with their notified body, which we believe is worth highlighting to raise awareness.
The medical device manufacturer in question had recently withdrawn their UKCA certification. However, during their latest audit for CE certification, a major non-conformity was raised by the notified body due to the presence of the UKCA symbol on the label of some existing stock. This stock had been manufactured while the UKCA certification was still valid, but by the time of the audit, the certification had been withdrawn.
Although it may seem reasonable to assume that, since the stock was manufactured in full compliance with UKCA regulations, it could be stored until shipped or placed on the market, this assumption is incorrect. The critical issue is that the product cannot be placed on the market without a current, valid UKCA certificate.
This situation understandably causes some confusion, but it is a scenario that occasionally arises. Manufacturers are consistently advised to adopt a risk-based approach. When assessing the actual risks to end users or patients—especially considering that the stock in question was also CE marked, a more stringent certification process—there are no significant risks. However, despite this, the notified body insisted that the UKCA symbol be removed from the products before they could be placed on the market.
The notified body’s rationale was that “placing on the market” is not considered to occur when devices are merely stored in the manufacturer’s warehouse.
Key lessons for manufacturers:
- Carefully manage your stock. Devices under certification can only be sold if the certification is valid at the time of placing on the market. Simply storing them in your warehouse is not typically considered “placing on the market.”
- Proactively manage certification validity and inventory labelling to ensure continuous market access and avoid enforcement actions.
If you are unsure about the requirements you need to meet to remain compliant or would like to discuss this further, please don’t hesitate to reach out. We’d be happy to assist with any questions or concerns.
