Online platforms could see European Union (EU) surveillance regulations block products for sale when they come into force this month.
While those who manufacture import and deliver products still carry the responsibility for making their products safe, online platforms will also need to ensure the stuff they sell is safe and compliant with regulations, lawyers say.
“All economic operators in the supply chain now face legal obligations to cooperate with market surveillance authorities regarding corrective actions that could eliminate or mitigate risks presented by products the contributed to make available on the EU market,” Michael Finn, partner at the law firm Pinsent Masons said.
The EU’s Market Surveillance Regulation (MSR) was signed off in 2019, but comes into effect 16 July 2021 and brings online platforms into the compliance regime for goods sold in the region.
In practical terms, if the regulator finds products that it believes represent a health risk, they can make the so-called “economic operator” take corrective action. That could mean bringing the product into compliance with regulations, or prohibiting or restricting the product getting to market. In practical terms, online platforms may have to withdrawal, recall or destroy products.
“Companies operating or wanting to operate in the EU should review the MSR and audit their current product portfolio to see whether they are currently in compliance with product regulations,” Finn said. “The MSR will give extra weight to how the existing product laws are enforced, so a review of business activities and product portfolios would be prudent.”
While the product categories in MSR do not specifically name medical devices, they are also caught by the regulations.
“Digital health companies should be aware that medical devices and IVDs do fall within the scope of the MSR,” Saadi Siddiky, a lawyer at Mason Hayes and Curran, said. “Therefore, all operators within the supply chain for such devices need to be aware of the general obligations that will apply to them from 16 July 2021.”