Essentials of European Medical Device Regulatory Affairs - October 2019
MDR Transition timing
2014 Device No.1 Certified under current MD Directive
2019 Device No.1 Re‐certified under current MD Directive or MDR
2024 Device No.1 Re‐certified under MDR
2016 Device No.2 Certified under current MD Directive
2021 Device No.2 Re‐Certified under MDR
2015
2017
2019
2020
2021
2024
2025
May 2017 Transition period starts
Q1-Q3 2019 NBs re-designation under MDR so far 5 only NBs can issue MDR certs
May 2024 All MDs must be certified under new MDR
May 2020 Transition period ends
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IVDR Transition timing
2017 Device No.1 Certified under current IVD Directive
2022 Device No.1 Re-certified
2020 Device No.1 Re-certified under current IVD Directive or IVDR
2022 Device No.2 Re‐certified under IVDR
2019 Device No.2 Certified under current IVD Directive or IVDR
under IVDR
2016
2017
2018
2019
2021
2023
2025
May 2017 Transition period starts
Early 2025 Devices placed on EU market must be certified under new IVDR
2019 NBs re-designation so far No NBs can issue IVDR certs
May 2022 Transition period ends
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