In the rapidly evolving world of medical devices, regulatory transitions can significantly impact product availability and compliance.
Mark your calendars for an important date: May 26, 2024.
This is the deadline for transitioning to the Medical Device Regulation (MDR) 2017/745.

confinis strongly advises its clients to take the following steps:

Evaluate Your Portfolio: Assess which of your products are affected by the MDR transition and ensure access to the extended transition timelines granted by the EU Regulation 2023/607.

Ensure Compliance: Verify that your Quality Management System (QMS) is aligned with MDR requirements and initiate the certification process with a Notified Body, if necessary.

Certain conditions allow for an extended transition period, such as having lodged an application with a Notified Body by May 26th, 2024 and have a contract signed by September 26, 2024, and ensuring your devices continue to comply with previously applicable EU legislation without significant changes in design or intended purpose.

Stay Informed: Regulations and guidelines are subject to updates. Stay abreast of these changes to navigate the transition smoothly.

confinis is here to support you

Should you have questions or need further clarification, don’t hesitate to reach out. We are committed to facilitating a seamless transition for you.