The deadline to comply with the new Medical Devices Regulation (MDR) is fast approaching. If you sell medical devices in the European Union, it’s time to develop a successful transition strategy.
MDD vs. MDR: What’s Changing
From the introduction of software medical devices to the increased use of implants, the medical device industry has changed tremendously since the original Medical Devices Directive (MDD) regulations came into effect in 1992. The new MDR regulations, approved in March 2017, aim to increase medical device safety, place greater emphasis on thorough reviews by Notified Bodies, and ensure compliance is supported by data and technical documentation.
The Transition Timeline
The compliance date for medical devices is May 26, 2020. On May 26, 2024, MDD certificates will no longer be valid. It’s important to understand when your device certificates’ renew and when design changes are scheduled in relation to this timeline.
Tips for a Smooth Transition
Complying with the MDR and its more stringent requirements is a big undertaking. Here are a few tips to help you get started:
- Audit your current devices. Assess all of your current CE-marked devices relative to the new MDR guidelines. Clinical data, technical documentation, and labeling may need to be updated.
- Review your systems, processes, and agreements. It will be important to assess your overall procedures around clinical evaluation, technical documentation, risk management files, Clinical Evaluation Reports, post-market surveillance processes, and Economic Operator agreements.
- Find more resources. Once you know what gaps exist, you will need to conduct the work to get the required data and documentation up to date across your entire portfolio. For most, this will require hiring additional regulatory team members or finding a trusted partner.
Rely on Expertise
Don’t take a chance with your ability to do business in the European Union. If you’re unsure of how to navigate the MDR changes, reach out to an expert. The 80/20 Quality Consulting group is a leader in regulatory consulting and has over 20 years of experience in the medical device industry. Our team is ready to help you identify where you may have gaps, create a solid plan, and get certified by the deadline. The deadline is fast approaching—contact us today to get started.