Legacy device on borrowed time? Let’s push it over the line.

Regulatory Affairs Consulting

We can help you move legacy medical devices and IVDs onto MDR (2017/745) or IVDR (2017/746) certification before the transition deadlines.

Have you completed your MDR or IVDR transition?

Do you know the final dates that you can place your devices on the market under the directives?

Have you submitted all of your technical documentation for Notified Body assessment?

We can help you accelerate progress, and complete the transition.

Commission Implementing Regulation (EU) 2021/607 defined the extension to timelines for MDR.
26 May 2021: All devices not covered by a transitional period must comply with MDR (i.e. new devices).
26 May 2024: Last date to lodge an application with a Notified Body.
26 May 2026: Class III custom-made implantable devices must have a Notified Body certificate.
31 Dec 2027: End of transition period for Class III and Class IIb implantable devices.
31 Dec 2028: End of transition period for Class IIb (non-implantable), Class IIa, Class I sterile, Class I measuring, Class I reusable.
REGULATION (EU) 2024/1860 defined the transitional extensions.
26 May 2022: All devices not covered by a transition period must comply with IVDR.
26 May 2025: Last date to lodge an application with a Notified Body for Class D devices, and previously certified devices.
26 May 2026: Last date to lodge an application with a Notified Body for Class C devices.
26 May 2027: Last date to lodge an application with a Notified Body for Class B and Class A sterile devices.
31 Dec 2027: End of transition period for Class D devices, and for devices that had a notified body certificate under IVDD (e.g. self-test IVDs).
31 Dec 2028: End of transition period for Class C devices.
31 Dec 2029: End of transition period for Class B and Class A sterile devices.
You need to carefully check the classification of the device under the directives and the regulations, and compare the routes to conformity.
In the world of non-active devices, Class I Reusable Surgical Instruments are the main example. These devices did not require a certificate under the directives, but do under the regulations.