By Carl Manthe, Director and Medical Technology Industry Lead, Integrated Project Management Company, Inc. We all have limited time and resources, both in our personal…
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 Device Regulations (MDR). The bad news: the extension applies to notified bodies, not to medical device companies, whose submissions are due by May 26, 2024.
While it’s not quite time to throw in the towel, if you want to continue to sell in the European market, it’s time to get moving.
Companies with products approved under MDD may not have fulfilled all of the MDR requirements. Products must be in compliance 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, clinical, surveillance, and other information has to be maintained in the European Database on Medical Devices (EUDAMED).
Here are eight challenges to complying with MDR on time and ways to tackle those challenges.
Medical device companies’ submissions, including technical documentation and signed proposals, are due to notified bodies by May 26, 2024. Unless the European Commission decides to extend the deadline—and there’s no indication it will—this is it.
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.
|Medical Device Class||Deadline to Submit to Notified Body and Have Acceptable Quality Management System in Place||Transition Timeline|
|Class III custom-made implantable devices||May 26, 2024||May 26, 2026|
|Medium- and Low-Risk Legacy Class IIa and Class I devices||May 26, 2024||December 31, 2028|
|High-Risk Legacy Class III and Class IIb implantable devices||May 26, 2024||December 31, 2027|
Note that only manufacturers with valid MDD/AIMDD certificates and those who have taken reasonable steps to transition to the EU MDR will be granted the extension. This also assumes there are no significant changes in the design or intended purpose of medical devices. For details, visit The European Union Medical Device Regulation.
Companies may choose not to go through the hassle of MDR 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 and 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.
While there are hopes to add notified bodies and their review deadlines have been extended, 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.
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.
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 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.
Not only do companies have to get packaging and labeling ready and up to MDR 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, clinical investigations and performance studies, vigilance and post-market surveillance, and clinical evaluation plans (CEP) and reports (CER).
Some companies delayed the launch of MDD-compliant medical devices due to Covid restrictions. They may have enhanced the products pre-launch. However, significant changes to existing products due to software and/or hardware upgrades may trigger a brand-new submission.
Actions: Get ready to prepare a new submission, as well as verification and validation of the existing product.
In most cases, achieving EU MDR compliance is not just a paper exercise in resubmitting your application. There are new requirements, especially in the realm of clinical 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.
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.”
Vinesh Naik, Consultant
Eric Hill, Senior 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 that ensures deadlines are met.
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