Mid-Size Medtech Company With a Borderline Product Defines Strategy for EU Launch

Client Challenge

A mid-size medtech company had products on the market in the United States (US), but no European Union (EU) presence. Their goal was to launch one of their US-approved borderline products in the EU market.

The company sought support in developing a regulatory strategy for the EU launch of this product, with an aggressive timeline to launch. The client chose Alira Health because they had a team of in-house experts covering all types of medical devices, including borderline products and extensive experience with notified bodies dealing with this type of device.

Our Approach

The Alira Health Regulatory team proposed a stepwise approach.

Step 1: Confirming Medical Device Classification

The team needed to understand if the product could be considered a medical device under the Medical Device Regulation (MDR), and under which classification rule. To do so, the team took these actions:

• Analyzed each of the ingredients present in the product separately
• Documented the ingredient’s individual properties, mode of action and their concentrations in the product as well as how they worked together
• Understood and documented the intended use and claims of the product as a whole
• Conducted a comprehensive classification analysis

Step 2: Conducting Gap Analysis

Because the client had already launched the product in the US, the team was able to compare their evidence package from the FDA approval with the MDR requirements for the EU. The team performed these tasks:

• Identified and mapped the existing gaps between what the client had and what they needed
• Prioritized the gaps based on the amount of data to be generated and based on their impact on the client’s budget and timelines
• Developed a strategy to fill in these gaps

For example, the team identified a major gap in terms of long-term toxicology studies and recommended that the client address this immediately because it would affect their planned schedule.

Step 3: Identifying and Contracting a Notified Body

The team needed to connect with an EU notified body, a challenging task because medtech companies struggle to find notified bodies due to their limited availability. The team took these actions: 

• Developed a pool of potential notified bodies able to evaluate this product
• Filtered the list based on those that offered expedited review to meet the client’s timeline
• Established a relationship with one of the notified bodies
• Presented the rationale for the product’s classification and related documentation to them

Outcomes

The Alira Health Regulatory team delivered a strategy that supported the client on their first step towards launching a borderline medical device in the EU market.

The notified body agreed that the product was a medical device and agreed with the proposed classification under the MDR based on the information provided by the Alira Health Regulatory team. The notified body signed an agreement with the client to start the MDR certification procedure for certification in the EU.

Key Success Factors

The Alira Health Regulatory team guided the client through the first stage of entering the EU market. The team deployed their expertise in challenging borderline products and their experience in expediting the regulatory process to develop a strategy that would lead to a positive outcome as quickly as possible.

Alira Health’s regulatory experts knew how to approach the notified body and leveraged their deep understanding of the MDR requirements to successfully make the argument that this product should be classified as a medical device. The client was not familiar with the MDR and needed step-by-step guidance throughout the process. Alira Health managed client expectations, worked with their ambitious timeline, and helped the client to reach this major milestone.