The 3 Big Drivers Accelerating Change in MedTech
By Carl Manthe, Director and Medical Technology Industry Lead, Integrated Project Management Company, Inc. The U.S. MedTech industry is a dynamic and rapidly evolving landscape,…
Medical device and diagnostics companies found out the hard way that complying with the European Union In Vitro Diagnostic Regulation (IVDR) is more challenging than expected. Though final safety certification deadlines have been extended, time is not on your side. All CE-certified devices must comply with IVDR by May 2025 or upon certificate expiry.
If you want to continue to sell in Europe, it’s time to take on—or strategically choose to avoid—the challenges of compliance.
Companies with products approved under the In Vitro Diagnostics Directive (IVDD) may not have fulfilled all the IVDR requirements. Products must comply with harmonized safety standards. Companies must establish, document, and implement a risk management plan that identifies and eliminates potential hazards both during manufacture and post market. And registration, performance, surveillance, and other information has to be maintained in the European Database on Medical Devices (EUDAMED).
Here are the challenges to complying with IVDR on time and ways to tackle those challenges.
Submission deadlines are looming.
Submissions from diagnostic manufacturers, including technical documentation and signed proposals, are due as soon as May 2025. Unless the European Commission decides to extend the deadlines—and there’s no indication it will—this is it.
Compliance Deadlines for Each In Vitro Device Class
- May 26, 2025: All IVDD CE certified devices, Class D self-declared IVDD devices
- May 26, 2026: Class C self-declared IVDD devices
- May 26, 2027: Class B and A sterile self-declared IVDD devices; all devices must comply with the IVDR
For details, visit The European Union In Vitro Diagnostics Regulation
Actions: If you haven’t already, act now. Gain management approval, make the commitment, and step on the accelerator. Identify the resources you need, start preparing and gathering information for EUDAMED, and begin risk management planning.
It requires top-down strategic planning.
Companies may choose not to go through the hassle of IVDR compliance. If executives make that choice, they have to accept the loss of income and potentially a first-mover’s advantage from participating in the European market. However, if they choose to submit, they must prioritize the effort and arm the compliance team with the time and resources to achieve compliance on time.
Actions: Compliance will require aggressive prioritization, planning, replanning, and potentially change management. Implement a systematic approach and identify what is important to achieve the goal. Select which products are strategically most important to the business. Enlist executives to be advocates and communicators to ensure the organization knows it’s a priority. If necessary, get help from a consultant or third-party company to lead planning and implementation.
Notified bodies are strapped.
While there are hopes to add notified bodies, they are still going to be a bottleneck. Review turnaround time can be 12 or even 15 months, and other products are already in line.
Actions: Contact multiple notified bodies now to get in line. Determine if expedite fees would be worth the investment and get approval for the additional outlay.
Resources are limited.
Even before the “great resignation,” resources were constrained. The number of employees, the level of experience, and subject matter expertise have declined at many companies. Hiring, training, and retaining staff, as well as capturing historical internal knowledge, continue to be challenging.
Actions: If the program is deemed a priority, the decision to allocate the appropriate resources is easier. Assign the internal resources with the most applicable experience and expertise. Train SMEs on documentation and operating procedures. Hire third-party consultants to fill in leadership, knowledge, and/or staffing gaps where needed.
Supply chains can be unreliable.
The pandemic revealed supply chain risks that won’t be solved quickly. Disruptions are still delaying some materials and causing price volatility on others.
Actions: Work with your supply chain team and vendors to proactively purchase parts or materials ahead of time. Factor supply chain risk, not just the landed component cost, into your supply chain calculations. Get management approval to pay expedited fees to avoid delays. You may even consider contracting duplicate materials from a backup supplier.
There are new performance evaluation requirements.
Performance evaluations need to be demonstrated in accordance with the General Safety and Performance Requirements (GSPR) using the analytical performance (APR), clinical performance (CPR), scientific validity (SVR), and performance evaluation (PER) reports.
Actions: Work with your functional teams to create a cohesive performance evaluation plan (PEP). Make sure the conclusions and data in the supporting reports conform with the GSPR. If you need additional studies to gather that data, plan early to allow time to conduct the studies and analyze the resulting data.
There are new labeling and EUDAMED requirements.
Not only do companies have to get packaging and labeling ready and up to IVDR standards, but they also have to navigate EUDAMED’s classifications, registration, and maintenance protocols.
Actions: Carefully follow EUDAMED requirements for unique device identification (UDI) and device registration, performance studies, vigilance and post-market surveillance, and performance evaluations.
EU IVDR compliance is not just resubmitting your products.
In most cases, achieving EU IVDR is not just a paper exercise in resubmitting your application. There are new requirements, especially in the realm of performance data. You may not have the necessary data to make a proper submission and may need to undertake studies to produce it.
Actions: After prioritizing your products and understanding the new requirements, review the prior filings and design history files to evaluate the available data and information. Identify any gaps. Decide if you need to remediate or supplement the information available, and begin this work as soon as possible. This might be the longest part of your submission timeline.
IPM’s work on EU MDR projects can help guide your EU IVDR compliance efforts. Download “EU MDR: Achieving On-Time Compliance with Lasting Benefits.”
Authors:
Vinesh Naik, Consultant
Kara Nystrom, Consultant
Integrated Project Management Company, Inc.
Contact one of our quality and compliance experts to discuss how we can develop a customized, cross-functional roadmap to meet critical deadlines.
Service: Quality and Compliance
Industries: Life Sciences, Medical Technology