CE certificate suspended or withdrawn
A notified body has the following authorities: to issue, suspend and definitively withdraw a CE certificate. A notified body can do this whenever a manufacturer of a medical device or IVD (temporarily) cannot fulfil requirements imposed by law.
Difference between suspension and withdrawal
- A suspension is a temporary measure. During a suspension the manufacturer is given time to implement improvement measures which are intended to ensure that the medical device or IVD complies with the legislation. Once the medical device or IVD is again compliant, the notified body can terminate the suspension.
- The withdrawal of a CE certificate is a definitive measure. The manufacturer must then go through the entire process again in order to obtain a CE certificate.
What effect does this have on products which are already in stock?
The suspension or withdrawal of a CE certificate only has an effect on those products which the manufacturer has not yet sold. Products which are already with a supplier (distributor) or health care institution can, however, still be used. After all, when these products were sold by the manufacturer, the CE certificate was still valid.
Following the suspension or withdrawal of the certificate the manufacturer is not allowed to market any new products.
Can the Inspectorate suspend or withdraw a CE certificate?
The Inspectorate is not authorised to suspend or withdraw a CE certificate. However, the Inspectorate can request the notified body to do this. The Inspectorate can also impose an enforcement measure on the manufacturer in the event of violations. This is possible, for example, if a manufacturer markets the medical device or IVD without a CE certificate.
Can the Inspectorate prohibit a medical device?
The Inspectorate can order the trade, import, export or delivery of a medical device or IVD to be suspended or terminated.
The Inspectorate is only allowed to do this if there is a significant risk to public health or the safety of citizens. Only the Minister can prohibit devices or their use in the event of a serious danger to public health.