The EU Medical Device Regulations: Fears and Frustrations for Dental Implant Manufacturers
For over twenty years, the Medical Device Directive (MDD) has regulated medical devices in the EU, and assured safety and performance. However, with rapid advancements in technology, evolving healthcare needs, and emerging challenges, the EU recently introduced more robust and comprehensive Medical Device Regulations (MDR) to replace the aging MDD.
The MDR ushers in a new regulatory era for medical devices with stricter requirements to ensure higher product safety, efficacy, and quality standards. Moving forward, all dental implant devices will be held to increased scrutiny of their quality and rigid requirements for clinical evidence.
And though many of the changes will be beneficial overall, critics say the regulations will hinder innovation, significantly affecting how many products providers can bring to the market and increasing their initial costs.
In the face of so much change, dental implant manufacturers are understandably worried and frustrated by the challenges ahead and the uncertainty of how to best plan and proceed.
Lack of clarity around timing and costs
The MDR requires a comprehensive process to apply for certification and to succeed, and firms need to have an in-depth understanding of the EU's regulatory requirements and compliance guidelines.
Many dental implant manufacturers are frustrated and need more tools and understanding to ensure compliance with the requirements. They’re rightly worried about whether in-house resources can manage the task, how much time and money will be needed to get an entire product catalog approved (or even just a few select products), whether they can stay competitive during the process, and how many products they might have to pull from the market in the future.
The necessity to conduct clinical testing is crucial within the new MDR requirements. Clinical evidence is typically obtained through actual patient trials and generally requires costly maintenance to keep up-to-date. Moreover, putting resources towards MDR could slow product development and innovation, leading to even more barriers toward ongoing sales and marketing objectives.
The challenge is increasingly difficult for manufacturers with a more extensive product catalog since they will likely be delayed. At Elos Medtech, we spent three years getting our entire product catalog MDR approved, and many other firms are now only in the early stages of obtaining MDR certifications.
Firms may face unexpected challenges with customers looking elsewhere to fulfill their product needs if they can't meet the timelines for their product approvals. Moreover, the risk of MDR compliance rejection can also result in slower product releases with lost revenue while waiting for a new application to be processed.
Market access challenges
Studies are typically performed at the implant level, requiring applicants to set up costly trials to collect abutment and prosthetics usage data.
Implant manufacturers usually work with various third-party providers, who may lack the resources to set up expensive trials to gather data on abutment and prosthetics usage. In these cases, implant manufacturers must find ways to ensure they can still offer a complete product catalog.
Moreover, older and less popular products are likely to be discontinued in the market because the new requirements are too great to justify the cost and time investment needed; this will be especially true for specialized devices sold in smaller quantities.
A hindrance to innovation
Stricter MDR requirements and tighter controls pose real challenges to innovation in the dental implant market. Increased emphasis on robust clinical evaluations and evidence, extended approval timelines, and more costly product development means that implant manufacturers will be deterred from developing new technologies unless they are a sure bet for revenue generation.
Liability concerns for non-compliance
There are a variety of implications for non-MDR compliance ranging from fines to product delays, legal action, delayed product launches, loss of market share, and recalls to extensions of manufacturing licenses.
If a product is rejected during the MDR certification process, it will result in slower product releases with lost revenue while waiting for a new application to be processed. Even if products are already on the market with the MDD approval, they must be removed after MDR goes into effect.
Your trusted partner for achieving MDR compliance
Ensuring compliance amidst growing regulatory challenges is critical, but staying attentive to market success is equally important. Choosing the right partner is crucial for companies that need help knowing how to move forward.
At Elos Medtech, we have already made the significant time, financial, and intellectual investments required to put all our products through the rigorous MDR approval process. As one of the first to adapt to the new regulations, we are ready to offer you an effortless transformation to being able to offer fully compliant products.
While the usual turn-around time for an implant manufacturer working alone to become MDR compliant is two years or more, Elos Medtech can dramatically speed up that process. In just six months, we can be your legal manufacturer, and you can be ready to sell abutments repackaged with your company brand.
Plus, we’re already prepared with a plan for maintaining our products’ certification status, which is also a costly and laborious process since dentists have to work with product providers to deliver clinical data on an ongoing basis.
Elos Medtech is a pioneer in our industry and has consistently been pushing the boundaries of innovation. We were the first company to introduce a high-precision scan body to digitalize implant restorations: the Elos Accurate® Scan Body, the entry key to a truly open digital workflow.
We have partnerships with premium, global implant brands that use the Elos Accurate® Scan Body in their libraries and workflows today. With our MDR-compliant Elos Accurate® product line, you'll have access to the same benefits.
You'll be well-positioned to earn new business with a full line of precision products that give your users direct access to a truly open digital workflow. Focus your investment dollars on improvement, innovation, and new product development instead of working backward. We'll help you avoid pitfalls like gaps in your product portfolio from delays in approval and financial risks around customer retention.