IMed Consultancy explores the pros and cons of the regulatory scenario in key international markets within a changing regulatory environment
IMed Consultancy, a rising regulatory and compliance consultancy provider with over 50 years of experience supporting UK and international medical device and invitro device manufacturers launch and maintain their products on global markets, presents a guide to market entry looking at the EU, the UK and the USA. The whitepaper, available here: https://imedconsultancy.com, looks at these three major markets for medical devices, highlighting some key considerations relating to entering each of these geographies “first” to help manufacturers make informed decisions.
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.
“Manufacturers and stakeholders must navigate through a web of complex standards, guidelines, and country-specific regulations before they decide which markets will be the most profitable to enter and which ones they should tackle first, laying the groundworks for further expansion in the most time-efficient and cost-effective way possible. We felt the need to try and untangle some of this web for them, to ease their decision process and to hopefully shed some light on the different opportunities these areas have to offer.” comments Leeanne Baker, Managing Director and Quality & Regulatory Consultant.