Image source: Adobe Stock/wladimir1804
MDR CE marking pays greater attention to technical documentation, including clinical evaluation, post-marketing clinical follow-up and traceability of devices in the supply chain, and requires a very rich documentation package, reflecting rigorous testing procedures and quality standard. Despite the validity of the MDD CE certificates will expire in May 2024, Ultrasound, magnetic resonance and healthcare IT company Esaote has proactively started the migration process several months ago, to update the processes to the new standard, ensuring the highest level of quality in all the products’ development phases and manufacturing of its medical devices.
Our Quality Management System team has driven all the actions towards this new regulation, which focuses on quality and safety, significantly improving the regulatory rules for medical devices to be sold in EuropeFranco Fontana
The company reports that in 2022, it has 25 ultrasound medical devices and 2 MRI medical devices all certified under the new MDR CE Mark, issued by TÜV SÜD, and by the end of 2022 all Esaote ultrasound medical devices will switch to production under the MDR CE Mark. “At Esaote, we have created a dedicated company-wide, interdepartmental project team to complete the transition of all our medical devices from the MDD to the MDR in the most efficient way,” said Franco Fontana, CEO of Esaote. “Our Quality Management System team has driven all the actions towards this new regulation, which focuses on quality and safety, significantly improving the regulatory rules for medical devices to be sold in Europe.”
Currently, in EU around 23,000 certificates are covered by the MDD CE Mark, due to expire in 2024; at present, only 4,100 are already certified under the MDR CE Mark, with an average period of about 13-18 months to obtain the first certificate (manufacturer’s QMS and initial product assessment) (Source: European Commission).