CE certificate IUB Ballerine renewed

11 July 2022

The CE-certificate of IUB Ballerine™ was renewed on 22 June 2022. This means that IUB Ballerine™ complies with all laws and regulations for medical devices with risk class III. Titus Health Care is distributor of various copper coils in the Benelux including IUB Ballerine™.

What is a CE certificate?
IUB Ballerine™ has had a CE certificate since December 2014. The CE certificate is required to market medical devices in Europe. A notified body (appointed by the government) assesses whether a product complies with the essential requirements, including assessing the clinical evaluation of the manufacturer. The notified body concerned (GMED) has assessed that the Ballerine spiral complies with all essential requirements, after which the CE certificate has been issued.

On 20 July 2021 the CE-certificate of IUB Ballerine™ was temporarily suspended due to missing information in the technical file. Newly manufactured IUB Ballerine™ spirals however had to wait for the renewed CE-certificate before they were allowed to leave the factory. The IUB Ballerine™ spirals that were already on the market of course comply with all quality requirements and were therefore allowed to be sold and installed. OCON Healthcare, the manufacturer of IUB Ballerine™, submitted all missing information to the notified body for evaluation in order to complete the dossier. The notified body then issued a positive opinion and renewed the CE certificate of IUB Ballerine™ on 22 June 2022. The suspension has been lifted.

What does this mean for healthcare professionals and women?
With the new CE-certificate OCON Healthcare is again allowed to produce and sell new IUB Ballerine™ spirals to distributors. Healthcare professionals and women can therefore choose to insert IUB Ballerine™. Always consult your healthcare professional about which form of contraception is best for your personal situation. For more information, please consult the leaflet of IUB Ballerine™.

FDA clearance for research on IUB Ballerine™ in the United States
Recently OCON Healthcare, the manufacturer of Ballerine announced that the U.S. Food and Drug Administration (FDA) the Investigational New Drug (IND) application for IUB Ballerine™. An important milestone that will allow the start of a study in 2023 that is crucial for the authorisation of Ballerine in the United States. IUB Ballerine™ is currently available in 25 countries and more than 120,000 women have already opted for IUB Ballerine™. More countries will soon be added including Canada, Mexico and several countries in Central and South America.