Dear Sirs,
On 26th May 2021, Regulation (EU) 2017/745 on medical devices (MDR) entered into force. Orthoservice Ro+Ten has already applied the new requirements for products manufactured after that date. All products supplied from now on will conform with the requirements of the MDR.
However, as specified by the European Commission, there is a transitional period for the adaptation regarding both products compliant to the MDD (Directive 93/42/EEC) already on the market and the new requirements on product labelling.
Indeed, according to MDR Article 120(4), medical devices lawfully placed on the market pursuant to the MDD may continue to be made available on the market or put into service until 26th May 2025.
According to MDR, Article 123, until the EUDAMED database is fully functional, the corresponding provisions of Directive 93/42/EEC shall continue to apply for the purpose of meeting the obligations regarding exchange of information including, in particular, registration of devices and economic operators.
Fully implementation of the EUDAMED database is foreseen for May 2022.
Moreover, the obligation for placing the UDI carrier on medical devices applies from 26th May 2025, according to MDR Article 123(3)(f).
Orthoservice Ro+Ten is fully aware of the above obligations and will lawfully pursue them within the foreseen timeframe.
Best regards