This article has been updated to indicate that the European Union Medical Device Regulation deadline has been extended one year, until May 26, 2021.
According to a September survey from the Regulatory Affairs Professionals Society (RAPS), only 27% of medical industry leaders said they would be fully compliant by the European Union Medical Device Regulation (EU MDR) deadline, which at the time was May 26, 2020. If you are part of the 73% of companies that were behind, you’re not alone. And you have the opportunity to catch up, since the European Parliament has effectively moved the deadline by one year, to May 26, 2021. Don’t get complacent; 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, there may still be delays and business risks.
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 Regulatory 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.
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.
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.
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.
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.
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.
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” recently presented by IPM quality and regulatory experts Scott Babler and Tim Ehr at the 2019 American Medical Device Summit.
Contact one of our quality and regulatory experts to discuss your compliance program.
Service: Regulatory & Quality – Life Sciences | Product Development – Medical Technology
Industries: Life Sciences