Best foot forward: Which market to enter first?

by | Mar 21, 2024 | EU, IMed Consultancy, MDR, New Markets, UK, UKRP, USA

New markets - Mexico

A changing regulatory environment

In today’s rapidly evolving landscape of healthcare and technology, navigating the realm of regulatory compliance for medical devices has become an increasingly complex endeavour. With advancements in medical technology, the development and deployment of innovative devices have brought forth immense opportunities for improving patient care and revolutionizing the healthcare industry.

At the same time, however, major markets such as Europe and the UK are experiencing unprecedented regulatory shake-ups in the form of the introduction of the new EU MDR and IVDR and the Future UK Regulatory System. These regulations aim to safeguard patient safety, ensure device effectiveness, and maintain ethical standards throughout the product lifecycle, from design and manufacturing to post-market surveillance.

However, achieving regulatory compliance in this intricate landscape is no simple task. It requires a deep understanding of the evolving regulatory landscape, meticulous planning, robust quality management systems, and effective risk assessment strategies.

In this new blog series dedicated to International Market Entry, IMed’s team looks at three major markets for medical devices- the EU, the UK and the USA- highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions and prepare for engaging with regulatory experts that can help them enter foreign markets successfully to expand the global presence of their products.

This first of four instalment is dedicated to the global regulatory scenario and its opportunities.

Understanding the global regulatory scenario

Medical device manufacturers are facing a time of unprecedented uncertainty in the global regulatory landscape, mainly driven by the changes revolutionising the EU and UK markets. First, the introduction of the new EU MDR, with its protracted roll-out and delays to ensure suitable provisioning and to face the challenges imposed by the global pandemic, then Brexit, which effectively draws the UK out of the European regulatory environment and imposes the creation of new guidelines and regulations.

To add to this climate of uncertainty there have been various extensions for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation, with full compliance now set to come into force at end of 2027 for high-risk devices and at the end of 2028 for medium and certain lower risk devices.

Whist full compliance requirements for some products may be delayed in the EU, critical elements of regulation have already been enforceable for some time. Specifically, PMS requirements under the MDR have in fact been applicable since 26th May 2021 for all medical devices sold into the EU, regardless of a device’s MDR CE Marking status.

For businesses placing devices on the Northern Ireland market, where the EU MDR and EU IVDR have applied in Northern Ireland respectively since May 2021 and May 2022 there are several options for compliance based either the UK or EU regulatory systems.

Choosing the right market for your medical device

In this complex environment it is hardly surprising that medical device manufacturers with new devices, or that want to expand into new territories, are confused. Costs, timelines, shifting deadlines and potential extensions, these are all elements of uncertainty that make the decision regarding market entry, and particularly which market to enter first, highly complex.

There is of course no clear-cut answer for medical device manufacturers evaluating which market to enter first, but understanding the strengths and weaknesses of the regulatory systems currently active in these major markets can help frame the decision-making process.

Without a doubt, device maturity, therapeutic area and classification will drive the selection of the market most likely to yield success, but venturing forth without experienced guidance and advice means taking unnecessary risks in what is currently a changing and complex regulatory landscape.

The importance of relying on international regulatory experts

Securing the support of international regulatory experts will not only help navigate the complexities of specific markets, managing the expectations of their authorities efficiently and rapidly, but can help identify areas of overlap between the different geographies’ requirements to help structure longer term expansion strategies.

Read more about it on our white paper, available on our Resources page, or contact the team at IMed Consultancy for deeper insight into the UK, US and EU regulatory scenarios: hello@imedconsultancy.com

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