MDR / IVDR was published on 5 May 2017, MDR is applicable from 26 May 2020, IVDR from 26 May 2022.
Certificates issued between 25 May 2017 and 25 May 2020/2022 (IVDR) remain valid till their validity, but latest on 27 May 2024 they shall become void. (Article 120)
CE Certiso applied for MDR designation on 29 November 2017, and in December 2017 for IVDR designation.
CE Certiso can issue MDD/AIMDD certificates latest on 25 May 2020 (IVDD: 2022).
After this date certificates cannot be modified!
To be able to close the certification process CE Certiso accepts applications for MDD/AIMDD (change or new product) latest till September 2019.
In case the device contains medicine the deadline is May 2019.
In case the process cannot be closed until May 2020, it shall be repeated according to MDR.
Planned changes/new products (MDD)
Our clients are kindly requested to submit a plan of MDD submissions, MDR/IVDR application within 30 days after receiving the formal informative document.
In case the plan does not arrive latest on 31 May 2019 we cannot maintain any MDD capacity for any company.