Devices for children and rare conditions are most at risk from EU MDR

Does more regulation mean fewer devices? Surveys show device companies are pruning their portfolios.

By Amelia Hufford and Phillip Stoltzfus at 3Aware and Bassil Akra at AKRA TEAM GmbH

Uncertainty lingers for medical device manufacturers and clinicians in the wake of the application of Regulation (EU) 2017/745 (EU MDR). The EU MDR replaces the previous Medical Device Directives (MDD/AIMDD) and applies to all medical devices and manufacturers, even legacy-compliant devices.

Manufacturers face a long, burdensome and costly process to get certification for products that may have been available in the EU for many years. As a result, many are choosing to narrow their portfolio of offerings or delay the launch of innovative products on the European market, with one survey finding more than half of device companies are planning portfolio reductions, including discontinuation of a third of the products from those companies. Especially hard-hit are small and medium-sized enterprises, which represent 95% of medical device manufacturers in Europe. For healthcare institutions, this often means devices are simply unavailable on the market.

The EU MDR changes the amount, relevance and type of clinical data needed to market a medical device in the EU. If the manufacturer cannot leverage sufficient clinical data from existing sources, they must generate additional clinical data to address the various indications and patient populations covered by their promotional materials, including IFU.

Carrying out clinical studies is expensive, time consuming and, in many cases, unethical when referring to legacy and well-established devices. In some cases, the cost of generating clinical data outstrips the return on investment. While some manufacturers are turning to experienced partners to help meet this new bar, others are simply discontinuing products in the EU. A recent study confirms that 54% of respondents report that their company intends to remove devices currently CE marked under the directives from the EU market.

Orphan and pediatric devices at risk

Some of the products at most risk of being removed from the EU market are devices used to treat children or patients with rare indications.These devices generally have low sales and a reduced return on investment when compared to more common devices. If the cost of regulatory approval rises significantly, manufacturers are particularly likely to withdraw these devices from the market. Many devices are developed as a custom device or as a smaller version of a device manufactured for adults, and are often developed by small companies lacking extensive regulatory support resources. These manufacturers are not as prepared to manage the demands of increased requirements and often struggle to budget for such a shift in legislation.

Those manufacturers that do embark on clinical studies are met with challenges, particularly ethical concerns. Beyond the administrative challenges, the study must be designed and assessed to balance risk appropriately for the population under study, and the level of acceptable risk is different for minors and limited patient populations than it is for typical adults.

Off-label device usage is another source of uncertainty. When no appropriate alternative exists, many clinicians use products that are marketed for one indication but useful for another to treat vulnerable patients. For instance, a renal stent designed for adults has been used off-label in pediatric interventional cardiology. There is currently no reliable way for manufacturers to track the impact of these off-label uses, so by delisting a product in the EU, they may be withdrawing a product with an important, though rare, pediatric use.

Adapting to changing times

Manufacturers now face the challenge of tighter regulations while ensuring potentially life-saving and life-improving devices are available. For most, generating real-world evidence (RWE) is the biggest hurdle, so understanding and evaluating sources of real-world clinical data is vital. Medtech post-market surveillance and portfolio benefit-risk profiles are being reshaped by the insights into device performance and patient safety that RWE provides.

Rapid response and preparation are vital to a smooth transition with limited negative impact. The relevance and reliability of clinical data required by MDR has proved a significant challenge, with some companies narrowing their offering in the EU as a response. Unimpeded access to clinical data and efficient generation of highest-quality RWE will help manufacturers and regulators certify products and maintain compliance in a sustainable manner — and most importantly — ensure patients and clinicians are not left in the lurch.

Amelia Hufford, 3Aware co-founder and SVP of clinical and regulatory science, has 20 years of experience in scientific and clinical research including 10 years within the medtech industry, guiding the approval and continued market access of many medical products. She and 3Aware have pioneered methods of uncovering key elements of patient outcomes following treatment, negating the need for costly study investment and revealing a product’s value for patients.

Bassil Akra, CEO and owner of AKRA TEAM GmbH, was previously VP of strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH and has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Akra played an essential role during the implementation of the medical device regulation in Europe and was involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG) and International Standards.

Phillip Stoltzfus, 3Aware VP of marketing and PR, has more than 20 years of experience in academic medicine, community-based health care and healthtech, supporting biopharma and medtech. He has supported the launches of three start-ups offering first-of-its-kind solutions in their respective markets.

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.