The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition?
In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of ‎QUNIQUE Group, a quality and regulatory consultancy.
Bassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later.
Some of the highlights of the show include:
COVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity.
EU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market access.
EU MDR/IVDR Challenges:
Additional guidance needed during transition to apply these regulations.
Regulations put expectations that are not ready, such as EUDAMED.
Increased requirements on clinical evidence via higher clinical and performance evaluation requirements.
Continuous reporting increases expectations on resources for new and existing medical devices.
EU MDR/IVDR Timeline: Number of notified bodies isn’t the most important part. How much capacity do those notified bodies have to address market needs?
Tips for Medical Device and In-vitro Diagnostic Companies:
Read the regulation(s).
Understand implication(s) of regulation(s) on system(s).
Identify/re-evaluate notified bodies that can address needs.
Manage timeline/deadline for submission, implementation, certification.