Alira Health

Alira Health

The Challenges for Medtech in a Complex Regulatory Landscape in 2024

The regulatory landscape for medtech in the European Union (EU) is increasingly complex, continuously evolving, and challenging to navigate. At the same time, in the United States (US), medtech manufacturers can benefit from opportunities for assistance, such as the Breakthrough Devices Designation (BDD) and pre-submission meetings, which can result in faster approval.

To learn more about changes in the regulatory landscape in the US, the EU, the United Kingdom (UK), and Switzerland and what manufacturers should consider when developing their regulatory strategies and prioritizing their target markets, we spoke with Mercè Guerra, Manager, Regulatory Affairs, Alira Health.

Published on:
April 17, 2024
What markets are medtech manufacturers prioritizing today?

Mercè: Recently, our regulatory team has seen companies headquartered both outside and inside the EU prioritizing the US market, especially if they are launching their first product. We’ve identified two main reasons behind this trend, which we expect will continue for the next years. The first is the complex regulatory landscape in the EU. Medtech companies were concerned from the moment it became clear that the draft MDR (Medical Device Regulation) contained enormous changes from the previous Medical Devices Directives. Manufacturers worried about the impact on their existing devices and/or the delay in new device launches. Extensive guidance was needed to help companies fully understand the concepts and requirements. The guidance was slow to emerge, and much is still being published.

The second reason is that the FDA has taken actions to facilitate medtech manufacturers through their development and regulatory approval, making it easier to launch their products in the US. For example, the BDD offers continuous guidance from the FDA for those complex devices that qualify. With this guidance, companies can hopefully achieve faster approval. The EU currently has no such program.

In the US, manufacturers can benefit from the 510(k) pathway, an approval pathway that relies on the demonstration that a manufacturer’s product is at least somewhat equivalent to an existing product. This often allows companies to avoid generating clinical data, meaning this pathway is usually faster, although the downside is a potential restriction on the product’s indications for use. But companies generally accept an initial restriction because they can place the device on the US market and work on the regulatory requirements to expand the indications later.

Another benefit of seeking regulatory approval in the US first is that the FDA offers a formal process, the Q-Submission program, in which manufacturers submit a package with regulatory and device development questions, receive written feedback from the FDA, and have the opportunity to meet with FDA experts. Companies can have several valuable interactions with the FDA during the product development process, in sharp contrast to the EU where the Notified Bodies, entities that issue certificates for medical devices in the EU, are forbidden from having any consultancy activity with manufacturers.

A major factor in setting regulatory priorities is the evidence you have from clinical trials and other activities, including data you have gathered in other countries. Assess the evidence package you have from different points of view – regulatory, medical, biostatistics – and determine the gap between what you have and what you need.
Mercè Guerra Manager, Regulatory Affairs
How do the UK and Switzerland fit into the picture?

Mercè: Both the UK and Switzerland are large attractive markets for medtech manufacturers. Post-Brexit, the UK presents an additional challenge for manufacturers interested in both the EU and UK markets because they must now comply not only with the MDR but also with different UK requirements. There are some transitional provisions in place and most products with the CE mark in the EU or that are already compliant with the MDR will be accepted in the UK until 2028, contingent upon some specific administrative procedures, such as UK legal representation and registration on a UK website. But when the transition period ends, devices will have to be fully compliant with the UK regulations.

Switzerland is also now an independent regulatory country, but their new requirements closely follow the MDR, so Swiss compliance will be relatively straightforward for MDR-approved products.

In our experience, companies are focusing on the EU first and launching their products in the UK and Swiss markets before the transition period ends. Then the next step will be to comply with those countries’ regulations.

Given this landscape, how should companies set their regulatory priorities, especially with their first product launch?

Mercè: First, you must understand how your device will be classified in each region based on their regulatory framework because their rules differ. The device classification impacts the requirements you need to fulfill.

Based on the classification, it is crucial to prepare a complete regulatory strategy covering all the regulatory requirements applicable and drafting all the scenarios that could apply for the development of your product in the EU, then compare it with the US and other regions of interest. The scenarios should include the regulatory requirements, opportunities, risks, and benefits for each market, including timelines and testing requirements.

A major factor in setting regulatory priorities is the evidence you have from clinical trials and other activities, including data you have gathered in other countries. Assess the evidence package you have from different points of view – regulatory, medical, biostatistics – and determine the gap between what you have and what you need to meet the regulatory requirements for the markets you want to enter.

You can populate your regulatory strategy with all this information and then plan the pathways to regulatory approval in the different markets.

Of course, while regulatory issues are a major factor in your overall strategic approach, we highly recommend that you consider a market access analysis to understand the price and reimbursement (P&R) possibilities of the device in each market. To find the best market to enter with the highest likelihood of P&R success, your combined market access analysis and regulatory analysis will inform your decision.

What do companies with FDA approval for their products need to know about the EU environment?

Mercè: In addition to understanding the MDR, companies looking to launch in the EU need to know how to work with the Notified Bodies and the specificities of the EU Regulatory environment. While the FDA is a single entity that conducts many activities related to product development, including clinical trials and device approvals, the EU currently has more than 40 Notified Bodies, which are private entities focused specifically on device approvals. Not all Notified Bodies review all types of devices, so you may need to contact many of them to find out if they can evaluate your device. You also need to communicate with them about their costs, administrative procedures, and in particular, their availability and expected timelines for the evaluation.

Also, if you’re just starting clinical trials in the EU, you need to be aware that while the framework of the MDR is the same for all EU countries, the administrative procedures for each of the National Regulatory Agencies are different. And if you have a multi-country clinical trial, you need approval from each country in which the trial will be held.

You should learn about the EU environment early on so that your expectations are clear and you fully understand the landscape, the different bodies you need to work with, and the steps you must follow. You’ll want to integrate your planned regulatory interactions into your product timeline and overall strategic priorities.

What should a medtech company with a new product do first?

Mercè: If you’re launching a new product, you naturally want to have maximum success in the right markets as soon as possible. To achieve your goals in this evolving regulatory environment, you need not only a comprehensive regulatory strategy but also a comprehensive clinical and market access analysis.

Our clinical, regulatory, medical strategy, biometrics, real-world evidence, and market access experts can guide you through the often-daunting process of prioritizing your target markets.

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