How to Achieve MDR Compliance

In 2017, the European Union introduced new guidance for the medical device industry. The new Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and applies to all manufacturers who intend to sell medical devices in the European Economic Area (EEA), which includes the 27 countries of the European Union, as well as Iceland, Lichtenstein and Norway. It has far-reaching implications not only for European companies, but for U.S. companies as well.
 
Compliance with the MDR is essential for products to receive the CE mark, which is required to sell medical devices in the EEA and the first step in the certification process to sell in many countries outside the EEA. The MDR applies to existing as well as new products, so all products that received a CE mark under MDD must be recertified under MDR; the certification status does not rollover.
 
Beginning on May 26, 2024, all devices placed on the European Market must be in conformity with the MDR. Because the certification process is extensive, it can take up to 18 months for a company to complete. Companies that do not begin preparing for re-certification now are at risk of missing the deadline and losing certification for their products.

Re-Certification Challenges and Why MDR Matters

Companies will find the certification process more demanding than under the MDD, both because it takes time to become familiar with the new regulation and because the regulation itself is more extensive. For example, the MDR document is 369 pages, while the MDD was only 60 pages.  The European MDCG (Medical Device Coordination Group) has issued about 100 guidelines on how to read the new regulations. They present a common understanding of how the MDR should be applied in practice, aiming at an effective and harmonized implementation of the legislation.
 
Given the complexity of the new regulation, as well as the bottleneck caused by the limited amount of MDR-certified Notified Bodies (NB), it is not surprising that as of today, only a small percentage of 25,000 companies have certified products under MDR.¹ According to a study commissioned by the MDCG Task Force on Certification Capacity Monitoring, MDR certificates have not been issued yet for over 85% of the 500,000 plus devices that were previously certified under the MDD.²
 
The inability to re-register products can have consequences that extend far beyond a company’s bottom line. When companies analyze their product portfolios and determine that seeking re-certification is too burdensome for products with low sales volume or low profit margins, certain device categories may have significantly reduced product options or even none at all, especially in niche areas like medical products and devices for infants and children. This decrease in the diversity of therapies and devices will shrink diagnosis and treatment options for patients, not only in Europe, but also in markets around the world.

Best Practices for Recertification

As companies in the U.S. navigate the certification process for MDR, there are opportunities to learn from organizations who have already completed the process and have been re-certified. Dunlee, a developer of reliable, high quality and innovative imaging components, received already re-certification of its replacement CT tubes and identified three areas that can help companies of any size save time and resources throughout the recertification process. 

Phase One: Planning

Before diving into the recertification process, companies need to plan accordingly and ensure the project is prioritized across the organization.
 

• Allocate budget: It is critical to secure funding and management support early for the additional human resources efforts that are required in the recertification process.
• Implement new structures: It can be helpful to create new structures, such as a governance program, which can include establishing a project leader and filling other positions.

Phase Two: Analysis

When planning is complete, it is time to assess your product landscapes and identify ways to make the recertification process easier.
 
Analyze product portfolio: Take a holistic look at your products and think strategically about specific products that should be discontinued. For example, your portfolio may contain some older products, for which demand has decreased over the years. In this way, the re-certification process can be used to clean up portfolios, while simultaneously reducing the effort required to re-certify all products. 
Conduct a gap assessment: A gap assessment of QMS and Technical Documentation (TD) with regards to MDR sets the stage for implementation. By investigating new requirements and identifying gaps related to processes, templates and records at this stage, companies can prevent surprises and unnecessary delays, and ensure they have all necessary steps done for the MDR process.

Phase Three: Implementation

After closing all identified gaps, you can move into the third phase: implementation. Ideally, work completed in the first two phases will make this phase considerably more efficient.
 

• Create a sample: If you have multiple products/technical files, complete one technical documentation as a “sample,” rather than working on all simultaneously. When the first document is complete, it can be sent to the NB for review and feedback. NBs may interpret the MDR documents differently, and by testing a sample with each NB, you can help avoid reworking and resubmitting the documents because of differing interpretations. Clarifying interpretations early with one sample can help ensure the NB gaps are closed and this insight can be used to finalize the remaining TDs subsequently.
• Check in on capacity: Ask your NB about its capacity about 3-6 months before documents are submitted, so the NB can plan accordingly and have the time and capacity to review the documentation. This will help ensure the NB has the capacity to review and minimizes the potential for a bottleneck, which can stymie many companies’ efforts to achieve re-registration quickly.

MDR is Coming, but It’s Not Too Late to Prepare

With a deadline for recertification on the horizon, it’s important that companies begin the process for recertification now. While the implications of one company missing the deadline are largely limited to a product’s market availability and the financial impact, the impact on consumers becomes greater if a number of organizations delay. By using the best practices above and applying other key learnings, organizations can navigate the process more efficiently and help ensure their business operations in the EEA continue and that consumers have access to important products in their day-to-day lives.
 
References:
¹ See sources study of the DIHK  Befragung zur EU-Medizinprodukteverordnung (dihk.de)
² MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation. MedTech Europe. Posted 15.07.2022. https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-availability-of-medical-devices-in-2022-in-connection-to-the-medical-device-regulation-mdr-implementation/