195 days to go and still lost in the EU MDR transition?
From today on, 195 days are left to ensure that your products comply with the requirements of the Medical Device Regulation 2017/745 (MDR). For those still struggling to navigate the jungle of the MDR with its 123 Articles and 17 Annexes, our last minute MDR transition checklist might be your silver lining.
The transition deadline of the MDR is set for May 26, 2020 which means that in less than 222 days, your medical devices need to comply with the applicable requirements in order to obtain or maintain a valid CE certificate. Those using the “grace period” might have more time for the full implementation but be aware that requirements such as but not limited to Post Market Requirements are immediately applicable!
Since the full implementation comes with plenty of challenges and pitfalls, our experts at knoell have developed a last minute checklist to help you become MDR compliant in a time and cost effective manner. Using our checklist allows you to:
- verify the actual status of your processes and device related documentation;
- identify time critical steps to achieve compliance with MDR;
- plan and track the transition process for you and your team in order to meet the requirements.
knoell’s MDR checklist will enable you to identify the areas within your quality system that require change and/or modification. Each section of the checklist is cross-referenced to the applicable MDR requirements, and provide easy and clear step-by-step instructions to become compliant with the new regulations. knoell’s MDR checklist provides the information you need to validate your “gut instinct” regarding your company’s compliance to the new regulations, which will save your team precious time in the MDR decision making process.
Get in touch with us today!