8 Challenges to EU MDR Compliance and How to Tackle Them
Some good news: In March, final product safety certification deadlines were extended until 2027 or 2028 depending on the device class for European Union Medical…
In March 2023, the European Commission got approval to extend the European Union Medical Device Regulation (EU MDR) deadline, which is a relief for patients who need those devices. The extension does not, however, give extra time to the manufacturers to submit to their notified bodies. And they could use the time. EU Commission data released in December show that about 8,000 applications have been submitted. Under the old system, there are about 25,000 certificates. So, if your company is behind, you’re not alone.
EU MDR Deadlines
- May 26, 2023: Notified body final submission of signed proposals and technical documentation
- May 26, 2024: Final submission to notified body
- Dec. 31, 2027: MDR compliance for higher-risk devices that have been submitted by May 2024
- Dec. 31, 2028: MDR compliance for medium- and lower-risk devices that have been submitted by May 2024
EU MDR compliance involves significant work, including product portfolio review and prioritization, product up-classifications, expanded clinical requirements, significant documentation, new labeling, and post-market surveillance. Therefore, if your EU MDR program is not executed effectively, your ability to market in the EU is at risk.
Based on our work in supporting organizations’ EU MDR efforts and more than 30 years leading compliance projects with hundreds of medical device companies, IPM’s quality and compliance team has developed an approach to achieve on-time EU MDR compliance with lasting benefits. Following are steps you can take to accelerate successful compliance.
Confirm Your Current Status
Collect workstream data from all teams inside and outside of the organization and determine the most current program status. A brainstorming or tracking tool can be a simple way to provide an organized list of activities. The goal is to objectively define where you are, what remains to be completed, and how to best use your resources to meet the compliance deadlines.
Develop an Integrated Master Plan
Aggregate all the information, standardize terms and milestones, create a master tracker, and secure stakeholder alignment and buy-in. It is vital to have one source of truth that covers all the work and deliverable status and can serve as the roadmap to achieving compliance. You can use the master tracker to derive a master schedule that shows the critical path. You can also apply tools like Microsoft Power BI to clearly visualize the information by any tracked parameter and help optimize resource utilization.
Utilize Effective Program Management
An integrated plan needs a dedicated leader who will constantly monitor the status, drive progress, identify and mitigate risks, and find ways to remove impediments. A communication plan to effectively manage the flow of information among stakeholders and proactive organizational change management to promote sustained change should always be part of solid program management.
Review Plan and Adjust Resources
Analyze the integrated plan to confirm progress and assess resource needs. Leverage your experienced teams and knowledgeable resources (subject matter experts, project management support, quality, risk management, etc.) to deliver milestones on time. Since all team members have their day jobs as well, tough decisions may need to be made to prioritize tasks and free up resources.
Reevaluate Your Product Portfolio
Prioritize product order based on recertification dates or the need to make product changes. If products have been reclassified, you will need more time to comply. Evaluate criteria such as ease of conversion, return on investment, market opportunities, external partners, and bandwidth to rationalize each product line. Some products may need to be delayed or even removed from the EU market if you can’t achieve compliance, so ensure that the best decisions are being made for the business.
Use Invigorated Processes to Accelerate
Think differently about solutions. The workload can be reduced through portfolio rationalization and rigorous risk management. Take advantage of experienced teams; as they learn, they can apply their knowledge to speed the process. Resources and advice are available outside the organization; consider investing in third-party solutions rather than inventing them.
For a deeper dive into how you can accelerate your EU MDR compliance to ensure success, download “EU MDR: Achieving On-Time Compliance with Lasting Benefits” presented by IPM quality and compliance experts Tim Ehr and Scott Babler at the American Medical Device Summit.
Contact one of our quality and regulatory experts to discuss your compliance program.
Services: Quality and Compliance | Product Development
Industries: Life Sciences | Medical Technology