Iradimed was forced to halt sales of its 3880
MRI-compatible vital signs devices in the European Union (EU) after the
expiration of their CE Mark.
Iradimed will receive a 6-month CE certificate
for its other products while it resolves the issue with the 3880 patient
monitors. During that time, it has halted shipments of the 3880 patient vital
signs monitors to all markets in the European Economic Area (EEA).
The manufacturer of MRI-compatible medical
devices estimates the expiration will reduce 2019 revenue by 2%. This loss of
revenue highlights the importance of monitoring certifications and taking
action early to comply with new regulatory requirements.
EU Clinical Evaluation
Requirements
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.
Contact G&M Compliance to learn more about
the CE Mark.