Rise and shine Medical Device Software manufacturers! Get your coffee ready and sign-up for to our upcoming FREE breakfast club WEBINAR on October 19th, at 09.00! Join a 30-minute discussion with our experts about the MDR Transition period – What impact will it have on Medical Device Software (MDSW)?
In the beginning of 2023, EU countries agreed on introducing an extended transition period for MDR. For products that are CE-marked under MDD, MDR is mandatory (for most MDSW) from December 2027 or 2028 – depending on risk class. However, even though 2028 seems really far away, there are earlier timelines that must be met for MDD certified devices such as:
26.05.2024: Application conformity assessment Notified body
26.05.2024: Updated QMS (according to MDR article 10(9))
26.09.2024: Signed agreement with Notified body
What does this mean for the manufacturer? Do you have a strategy to fulfill these requirements? What challenges do you see?
Welcome to join us in these discussions and knowledge-sharing session about the MDR transition period and what it means for you as MDSW manufacturer.
Bring your appetite for knowledge, a sprinkle of curiosity, and let’s make this breakfast the most important meal of the regulatory day!