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Transitioning to the Medical Device Regulation (MDR) 2017/745

In the rapidly evolving world of medical devices, regulatory transitions can significantly impact product availability and compliance.

Mark your calendars for an important date: 26th May, 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 26th May 2024 and have a contract signed by 26th September 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. Swipe through to read how to start the transition to the MDR for uninterrupted access to the EU market.
To access our custom letter and tailored questionnaire for reaching out to manufactures send us an email at info.ch@confinis.com

Should you have questions or need further clarification, don’t hesitate to get in touch. We are committed to facilitating a seamless transition for you!