The medical technology company Injeq’s development yielded the desired outcome after many years of efforts as the company’s IQ-Tip needle received CE approval on December 21, 2021.
The needle can be used in lumbar punctures from newborns to the elderly, treatment punctures of children with leukemia being one of the main indications.
For medical devices, the CE certification translates to a marketing authorization in Europe. In other words, the company can expect a new era of growth as a result of the certification.
Injeq IQ-Tip is revolutionary as it knows exactly where the needle tip is. The aim of this feature is to make challenging punctures easier for physicians and to promote patient safety. The first commercial application of the needle is intended for lumbar punctures, where the IQ-Tip system gives an audiovisual alarm when the needle tip detects cerebrospinal fluid during the procedure.
“For medical devices, the CE certification translates to a marketing authorization. We have now been able to launch the commercialization measures we have been preparing for the Europe and the first deliveries to Germany have already been made. CE approval is a result of the team’s long-term development work and hard final efforts”, says Tommi Rasila, Injeq’s Chairman of the Board of Directors and Interim CEO.
CE certification has been granted for the IQ-Tip needle under the stringent Medical Device Regulation (MDR) of the EU. The regulatory requirements of medical devices changed during the development project, pushing Injeq into considerable additional work and efforts, including new clinical investigations. The work was completed in the autumn of 2020. The conformity of the Injeq IQ-Tip system was assessed by the distinguished Notified Body, TÜV SÜD Product Service GmbH in Germany.
The CE certification demonstrates that the medical device fulfils all requirements set and is in compliance with all relevant regulations. Medical devices are divided into three risk classes according to their intended purpose and related risks. Injeq IQ-Tip needle is a class III medical device, which is subject to the strictest requirements, and is one of the first MDR 2017/745 certified new products in this category in Finland. The analyzer of the IQ-Tip system is a class IIa device, and the special cable is a sterile class I device, which were certified by the Notified Body already in June 2021.
“The device must fulfil the requirements of the MDR throughout its life cycle in terms of product safety, clinical performance, risk management and follow-up. As a medical device manufacturer we must have a certified quality management system, which is subject to annual audits”, says Jussi Seitsonen, Head of Quality.
Injeq’s first goal will be to bring the IQ-Tip system as a part of routine treatment practices of children with leukemia and neonates in Europe. During the first year, Injeq aims to find clinical reference users, particularly in leading university hospitals. The future goal is to facilitate challenging lumbar punctures of adults, and later, other demanding punctures, starting from Europe and expanding around the world.