How changes to medical device regulation have increased training needs

Tom Melvin

Associate Professor in Medical Device Regulatory Affairs, School of Medicine,
Trinity College Dublin

The regulatory system for medical devices has changed significantly, which means medtech firms increasingly require people who understand the new requirements.

Ireland’s growing medical technologies (medtech) industry is the largest per capita employer in Europe. Firms in the sector make everything from heart valves, health apps and hip replacements to wheelchairs and neural transmitters.

Strict regulations in medical devices

Naturally, this is a highly regulated space. “The EU legislation surrounding these devices is intended to ensure the safety of patients without stifling innovation,” explains Tom Melvin, Associate Professor in Medical Device Regulatory Affairs, School of Medicine, Trinity College Dublin. “It’s a careful balance.”

However, medical device regulation in Europe has changed significantly, with more complex and stringent rules coming into force in May 2021. Anyone involved in the design, development, manufacture and distribution of medical devices intended for the EU market — including biomedical engineers and medical, legal, scientific and policy researchers — needs to understand how the updated rules affect patient safety and medtech innovation.

“There are now more plans, reports and processes that need to be adhered to in order to improve clinical evidence requirements and safety oversight,” says Professor Melvin. “Having an understanding of this new regulatory landscape is vital because it’s becoming an increasingly relevant part of a device’s translational journey from concept to implementation.”

Under the new rules, each medtech organisation
must appoint at least one person who is
responsible for regulatory compliance.

Increased demand for regulatory affairs training

Training needs for regulatory affairs have significantly increased, which is why Trinity College Dublin has created a new postgraduate part-time course called the MSc in Medical Device Regulatory Affairs.

This has been funded by the Human Capital Initiative and is delivered as a blend of four in-person sessions on campus, with the remainder delivered remotely. The course has been designed for students who are already employed and need work-life balance. The course’s first-ever intake, with many international students, comes from a mix of science, engineering and clinical backgrounds.

Career advantages for students

“Under the new rules, each medtech organisation must appoint at least one person who is responsible for regulatory compliance,” says Professor Melvin. “So, one of the drivers for the course is to help those individuals carry out their role with confidence. Other students already have regulatory and industry experience and want to deep-dive into topics of interest.”

Professor Melvin hopes the new MSc will benefit students in different ways. “It may help them develop further academic interests or find areas of interest that will boost their future careers,” he says. “Regulatory affairs have seen a lot of growth over the last three or four years and offer many employment opportunities across Ireland and Europe.”