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- ESAOTE completed the transition of its medical devices to the MDR-Medical Devices Regulation well before the expiration of the MDD-Medical Devices Directive 93/42/EEC certificates
GENOA, Italy, Dec. 13, 2022 /PRNewswire/ -- All companies involved in the production and marketing of medical devices have been struggling in the last 2-3 years to achieve the migration of their products and processes to MDD compliance (Medical Device Directive 93/42/EEC) to the new MDR Regulation.
The MDR CE marking pays increased attention to technical documentation, including clinical evaluation, post-market clinical follow-up and traceability of devices in the supply chain, and requires a very rich documentation package, reflecting quality control procedures. rigorous testing and quality standards.
Despite the fact that the validity of the MDD CE certificates will expire in May 2024, ESAOTE, a leading company in ultrasound, MRI and healthcare IT, 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 phases of product development and manufacturing of your medical devices.
By 2022, ESAOTE 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 go into production under the MDR CE mark.
"At Esaote, we have created a dedicated cross-departmental project team across the company to complete the transition of all our medical devices from MDD to MDR in the most efficient manner," said Franco Fontana, Esaote's CEO. "Our Quality Management System team has driven all actions towards this new regulation, which focuses on quality and safety, significantly improving the regulatory rules for medical devices sold in Europe."
Currently, in the EU, around 23,000 certificates are covered by the MDD CE mark, which expires in 2024; currently only 4,100 are already certified under the MDR CE mark, with an average period of around 13-18 months to obtain the first certificate (manufacturer's QMS and initial product assessment).*
More information about the ESAOTE Quality Management System and Certifications: https://www.esaote.com/about-esaote/innovation-technology/quality/
* Issuer: Official EC press release with relevant data: https://health.ec.europa.eu/latest-updates/notified-bodies-survey-certifications-and-applications-2022-10-26_en
About Esaote
The Esaote Group, which this year celebrates 40 years of activity, is a leader in the biomedical equipment sector, particularly in the areas of ultrasound, magnetic resonance imaging and software for managing the diagnostic process. At the end of 2021, the Group had 1,280 employees, more than half of whom were in Italy. With headquarters in Genoa and Florence and its own production and research units in Italy and the Netherlands, Esaote is present in 100 countries around the world. www.esaote.com
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