On May 5, 2017, the EU medical device regulation (2017 / 745, referred to as EU MDR) was issued and took effect on May 26, 2017. The new regulation sets up a three-year transition period. Due to various reasons (such as lack of sufficient announcement agencies, brexit, COVID-19, etc.), it was announced in April 2020 that it was extended for one year and has been officially implemented on May 26, 2021.
After the review of the Italian Ministry of health and the approval of the MDRCG, the Italian Ministry of health officially submitted the authorization for Bureau Veritas Italy to the European Commission on July 4, and officially announced it on the website of the public association announcement agency 28 days later as scheduled. On August 3, 2022, Bureau Veritas Italia S.p.A. (notified body No.: NB 1370) officially became the MDR notified body of EU medical device regulations, and was also the 32nd notified body to obtain MDR qualification.
Bureau Veritas Italy will officially announce the agency as CE-MDI, which can provide services for the medical device industry. As the former notified body of CE-MDD, Bureau Veritas Italy has its own advantages and experience, and will provide professional services for medical device manufacturers aiming at the EU.
At the same time, Bureau Veritas China will soon provide CE-MDR certification services for Chinese enterprises, and hopes to provide more perfect professional technical services for Chinese medical device enterprises in the future.