Skill-up now to survive regulatory change
Life Sciences The medtech sector in Europe faces the most meaningful regulatory change in two decades. A new breed of up-skilled talent is urgently required to help it succeed.
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.
“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.”
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.”