Ireland’s medtech sector, along with the rest of Europe, is facing one of the most meaningful regulatory change in two decades. How companies cope with implementation of these changes will be critical and could be the difference between success and failure.

Medtech companies are experienced in dealing with regulatory change - but the current changes bring unprecedented challenges to Ireland’s 450 medtech companies.

What’s needed, is a cadre of skilled regulatory talent that can help companies successfully navigate the new global regulatory territory successfully – and in close collaboration with industry, the association aims to help create them. Ireland’s medtech sector has a proud history of success with as many as 18 of the world’s top 25 medtech businesses having a base here and strong indigenous companies making a global mark and combined annual exports of E12.6 billion.

“The medtech sector is now experiencing global regulatory change at an unprecedented and relentless pace.” - Dr. Áine Fox, Senior Executive of the Irish Medtech Association.
 
“New regulatory requirements - sometimes with stringent implementation timelines - are emerging from multiple global jurisdictions. However, the cumulative impact on medtech manufacturers with products in multiple global markets is not always considered.”

“To help meet this demand for professionals with this important expertise, the Irish Medtech Association Skillnet has specialist programmes in the area of regulatoryaffairs, including a fundamentals in regulatory affairs programme, and a Masters in Medical Technology Regulatory Affairs”. Fox points out: “The revision of ISO13485:2016, designed to ensure medical device manufacturers’ quality management systems (QMS) comply with the regulations in the EU, Canada, Japan and Australia, has effectively created new QMS requirements for medical device manufacturers in markets outside the US.”
 

Ongoing challenges

 
While there are welcome moves towards global regulatory harmonisation, this will take time. Fox says: “In the meantime, key regulatory differences across markets present a continuing challenge to manufacturers.” At the same time, many regulators are increasingly asserting their mandate to protect public health with new proposals and changes. Fox points out: “The US Food and Drugs Administration (FDA) and other global regulatory bodies are showing significantly increased expectations for robust, high-quality human factors studies to support medical product and combination product regulatory submissions.”
 
Regulators are also increasingly focusing on a risk-based regulatory approach to health IT and cybersecurity as new eHealth technologies and solutions are developed. Aware that patients are playing a more active role in their own healthcare, regulators are also examining how device manufacturers can share data with patients. New technology is also bringing new regulation: draft regulatory guidance has recently been issued on technical considerations for manufacturing 3D printed devices.

At European level, new regulations concerning medical devices and in-vitro diagnostic medical devices contain significantly more detail than the current Directives. Secondary legislation - still to be developed - will fundamentally determine how effectively and smoothly industry can adapt to the new EU regulatory framework.
 
“We will continue advocacy with key stakeholders in conjunction with MedTech Europe as secondary legislative acts are developed and become ‘live’.”

Faced with this blizzard of regulatory change medtech companies will need to upskill. Fox says: “Expertise and skills in interpreting and complying with existing and emerging regulations will be critical in the face of increasing regulatory workloads. Companies will need to invest time and money to improve their upskilling strategies for their regulatory affairs professionals.”

She adds: “Medtech companies need to be fully aware of emerging guidance and trends in order to prepare for the future. Regulatory affairs is increasingly recognised as a having a whole-business impact for organisations, so demand for regulatory talent who can understand the implications of the changing global regulatory landscape is increasing.”