UL International, the notified body responsible for assessing conformity, found that the technical file for the device did not adhere to new EU clinical evaluation requirements.
When it comes to CE certification, “clinical evaluation” refers to the ongoing procedure for collecting, appraising, and analyzing clinical data related to the device. This also means analyzing whether there is sufficient evidence to confirm compliance with safety and performance standards (when using the device according to the manufacturer’s instructions).
The new clinical evaluation rules affect medical device manufacturers in several ways:
● Regulatory authorities may re-review technical documentation before high-risk devices are approved for CE marking.
● Notified bodies (responsible for assessing whether the device is compliant) must submit new technical review reports.
● Devices may be reclassified or “unclassified,” meaning they will require new or additional documentation to be considered compliant. Devices that were in the same risk category before may be separated now, requiring different levels of clinical documentation.
● Comparative evaluations are subject to stricter requirements. Manufacturers may need to produce additional data or analyze those data more thoroughly to demonstrate compliance to notified bodies and other regulatory authorities.
Iradimed’s failure to comply with aspects of these new clinical evaluation requirements led to expiration of the CE mark and temporary removal of the product from the market.
Penalties for Non-Compliance With CE Requirements
If Iradimed had continued to sell the devices without a valid CE mark, the company could have been subject to penalties from the EU.
The CE mark signifies a product that meets applicable standards and requirements for public health, safety, and environmental impact. While not all products require CE certification, if a product is subject to mandatory certification, it is unlawful and potentially unsafe to put it on the market without a CE mark.
Companies that sell unapproved products in the European Economic Area may face the following consequences:
● Temporary removal of the product from the EU market
● Limited movement of the product within the EU
● Requirement to restart the compliance process from the beginning
● Loss of the CE mark
● Product recall
● Restrictions or outright ban on marketing
● If the company continues to act unlawfully or the product presents a serious safety issue, permanent removal of the product from the EU market
The severity and time-span of the consequences will vary based on the type of product and the scale of non-compliance involved.
Contact G&M Compliance for More Information About the CE Mark
G&M Compliance is a full-service compliance partner for the CE mark. If you are looking to sell products in the EU, we can help you go to market faster and easier.
G&M Compliance also offers the Certificate Alert and Tracking System (CATS) to help you stay on top of upcoming expirations and renewal dates. With right compliance partner, you can ensure you never miss a compliance deadline.