When it comes to launching a medical device, one of the first things to consider is which market to enter first. To ensure a successful start and generate revenue for the business, manufacturers and stakeholders must navigate through a web of standards, guidelines, and country-specific regulations.
One of the challenges facing manufacturers today is navigating regulatory compliance for medical devices. With new EU MDR and IVDR regulations and the upcoming Future UK Regulatory System, it can be difficult to understand the regulatory requirements in major markets like Europe and the UK. As such, it’s important for companies to carefully consider their options before entering any new market.
In terms of global market opportunities, the medical devices industry is projected to continue growing, reaching $799.67 billion by 2030 with a CAGR of 5.9%. While there are many potential markets to choose from, this article will focus on three popular options: the EU, the UK, and the USA.
When considering entering these markets first, it’s important to keep in mind key factors such as market size, need for the device, medical landscape dynamics, procurement processes used by major buyers
