June, 2023 by Rebecca Reinkilde

The EU Medical Device Regulations: Predictions for Dental Implant Manufacturers

The Medical Devices Directive (MDD), in place since the early 1990s, was the primary regulatory framework for medical devices in the European Union for over two decades. However, regulators introduced the Medical Device Regulation (MDR) in May of 2021 in direct response to the evolving medical device landscape, with one of the goals being to ensure the highest level of patient safety.

The transition period to the new legislation has been extended from the original deadline of May 26, 2024, to December 31, 2027, for high-risk products and December 31, 2028, for medium and low-risk products.

The gradual shift from the MDD to the MDR has already started having a profound impact on medical device manufacturers, who must adhere to more rigorous procedures and meet higher standards for documentation, clinical evidence, and quality management systems.

This article will explore how the regulatory landscape is changing and what to expect as MDR deadlines get closer.

Clinical proof will be crucial for compliance (Clinical proof is essential)

It used to be enough for manufacturers to evaluate their products internally, but MDR requires independent third-party clinical proof of the quality and performance of a manufacturer's products. MDR aims to remove product risk by requiring a certified toxicologist’s review and approval of the documentation. 

Critics say the regulations will hinder innovation, significantly affecting how many products providers can bring to the market and increasing their initial costs. However, products will be safer for patients since having to provide documentation ensures providers have thoroughly tested devices before release.

In our view, these stronger regulations are necessary to avoid a “free-for-all” market with little to no regulation: patients should always be the top priority, and only thorough testing can ensure that products are truly safe and effective. That said, there will undoubtedly be a direct and measurable effect on manufacturers' ability to release new products and evolve current ones.

Detriment to other key business objectives (Innovation at risk)

The MDR is complex and contains over 150 pages, including addendums, guidelines, and supporting documentation. It is a comprehensive process to apply for an MDR certification and requires an in-depth understanding of the EU's regulatory requirements and compliance guidelines. Firms should plan for an extensive investment of time, money, and resources.

Clinical evidence is typically obtained through real-world trials and generally requires costly maintenance to keep up-to-date. As firms need to direct money and resources toward MDR, we expect a slowdown in product development and innovation in some cases. And budgets that are directed toward sales and marketing objectives may need to be redirected toward compliance initiatives.

Inability to meet MDR may cause shortages (Product shortage risk)

Studies are typically performed at the implant level, requiring applicants to set up costly trials to collect abutment and prosthetics usage data. Implant manufacturers typically 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 will face uncertainty about how they can continue offering a complete product catalog.

The new MDR regulations will most certainly result in a backlog of dental implant manufacturers' ability to introduce new products into the market. Products must be certified (or re-certified) before the deadline, or they will have to be pulled from the market.

It will be a real challenge for manufacturers if they cannot find a comparable replacement quickly to avoid a standstill in sales. Customers are quick to look elsewhere if they can no longer obtain the products they typically buy, and sudden loss of income due to incomplete product lines can become a substantial financial burden for any firm.

Less popular and older products will be prone to discontinuation (Old products phased out)

Older and less popular products are likely to be discontinued in the market, with the burden of the new requirements being too great to justify the cost and time investment needed; this will be especially true for specialized devices sold in smaller quantities.

On the other side of the Atlantic, some US manufacturers have decided that MDR approval is not worth the investment. As a result, those products will likely cease to exist in the EU after their MDD certificates expire.

Choosing the right partner is critical (Partnership is critical) 

Dental implant manufacturers need to be laser-focused on R&D, new product releases, sales objectives, and more—not on interpreting vast amounts of complex regulatory and legal language that are mandatory for meeting MDR regulations.

Only a select few firms can help you immediately tap into a portfolio of already cleared solutions. At Elos Medtech, we spent three years getting our entire product catalog MDR approved, while many other firms are now only in the early stages of obtaining MDR certifications.

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Most of the products we offer are already in-lab cleared, plus all of our products are 510(k) cleared, giving you direct, immediate access to a product line that meets the highest standards for the EU and US markets.

We have already updated our labeling to comply with regulations and are ready now to support you. Our fully MDR-compliant product lineup can help future-proof your firm and help you stay profitable with a fast turnaround time for offering MDR-approved devices.

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, including:

  •  Complete and open for major implant platforms
  • Digital workflow solutions for all implant indications
  •  Made for in-house or outsourced production
  •  Free and open libraries
  •  Product support and training
  •  An extensive network of software partners
  •  Customized packaging with your logo and product naming

 Elos infographic mdr 2023 b

Ensuring compliance amidst growing regulatory challenges is vital, but staying attentive to market success is equally important. For companies needing help knowing how to move forward, choosing a seasoned partner like Elos Medtech is critical to continued success.

 

June, 2023 by Rebecca Reinkilde
Libraries