For many devices, the cost of compliance with MDR and IVDR will be high and will require significant expertise. Manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new reforms. 

David Novotny and Angela Brown, Icon

The transition to the new European Union (EU) medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) represents one of the most disruptive transformations occurring in the medical device industry, touching every aspect of product development, production, distribution, and monitoring.

These regulations, which set forth more stringent safety and data requirements for devices distributed in the EU, are expected to greatly increase the complexity of keeping existing products on the market and introducing new ones.

The cost of complying with such stringent requirements will be high, requiring manufacturers to allocate a substantial budget annually for the next three years. Moreover, the transition is likely to cause hundreds, if not thousands, of products to leave the EU market.

Despite the challenges that these changes present, they may also introduce an opportunity for early movers to gain an edge over competitors who are slower to comply. To achieve success under MDR and IVDR, companies will have to generate and implement a strategic business plan.

A new business model

Until the new regulations go into effect, medical devices already on the market are considered safe by default. But with the deadlines approaching (May 2020 for MDR and May 2022 for IVDR), thousands of medical devices currently on the EU market will need to be recertified. Companies will have to submit vast amounts of clinical data in addition to implementing comprehensive post-market surveillance assessments and reporting.

Also, there is concern for the shortage of notified bodies (NBs), the entities needed to certify devices. MDR requires the European Commission to designate NBs to certify specific categories of medical devices. The influx of submissions will cause increased workloads that can overwhelm notified bodies, particularly for IVDs, creating backlogs that may delay product reviews.

Early movers may have the chance to gain market share over slower competitors that are unable to comply before the deadlines. In fact, this phenomenon is officially underway as of September 2019, when Biotronik became the first company to land MDR certification for a high-risk device. To follow this precedent, companies will need to create a comprehensive business plan that prepares them for success.

Why launch new products outside the EU?

MDR and IVDR significantly shift the global regulatory landscape. Historically, gaining a CE mark has been easier than obtaining FDA approval, yet the strict new data requirements and added steps of NBs and regulatory review may make pursuing approval in the U.S. quicker and easier. A single language, large patient populations, less-restrictive data-protection laws, robust IT infrastructure and central institutional review further contribute to study efficiency in the US. Similarly, countries in the Asia-Pacific and Latin American regions may be more attractive for some devices, particularly in regenerative medicine.

C-suite involvement

C-suite executives may play a critical role in preparing your business for success under MDR and IVDR. To engage them effectively, companies should consider involving upper management in the following processes:

• Cost assessment — Allocation of significant funds will be necessary to comply with the new regulations. This suggests that the chief financial officer (CFO) and chief operations officer (COO) should take the lead.
• Product triage — For many low-volume products, the added cost of MDR and IVDR will not be worth the expense, which may lead manufacturers to trim their offerings in Europe. This will have operational and strategic implications, suggesting a need for the involvement of the CFO, COO and CEO.
• Market entry strategy — Because the European clinical evidence requirements could end up being more stringent than U.S. requirements, U.S. market entry could potentially be more profitable, calling for a comprehensive market entry strategy.

With the first deadline quickly approaching in May 2020, manufacturers should immediately begin developing a strategic business model that will prepare them for success under the new reforms.

David Novotny is general manager and global head of medical device and diagnostic research services for Icon. He has more than18 years’ experience within the medical device, diagnostic, biotech and clinical industries.

 Angela Brown is director of  regulatory affairs for ICON’s medical device and diagnostics research unit. She has more than 20 years of regulatory affairs and quality assurance experience in the medical device industry, specializing in international regulatory affairs working with universities, start-up and blue-chip companies.