(Information sent by the signatory company)
– ESAOTE completed the transition of its medical devices to the MDR-Medical Devices Regulation long before the expiration of the MDD-Medical Devices Directive 93/42/EEC certificates
GENOVA, Italy, December 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 compliance with the MDD (Medical Devices Directive 93/42/ EEC) to the new MDR regulation.
The mark CE of MDR pays increased attention to technical documentation, including clinical evaluation, post-market clinical follow-up and device traceability in the supply chain, and requires a very rich documentation package, reflecting rigorous testing procedures and quality standards. quality.
Although the validity of the MDD CE certificates will expire in May 2024, ESAOTE, a leading ultrasound, MRI and healthcare IT company, has proactively started the migration process several months ago, to update processes to the new standard, ensuring the highest level of quality in all phases of development. of products and manufacturing of its medical devices.
In 2022, ESAUTE has 25 ultrasound medical devices y 2MRI medical devicesall certified under the new MDR CE mark, issued by TÜV SÜD, and by the end of 2022, all ESAOTE ultrasound medical devices will go to the 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, CEO of Esaote. “Our Quality Management System team has promoted all actions towards this new regulation, which focuses on the quality and the securitysignificantly 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 and Certification System: https://www.esaote.com/about-esaote/innovation-technology/quality/
* Issuer: Official EC press release with the 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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