Irish Medtech Association Director Sinead Keogh said: “We have been advocating for an outcome to talks that reflect the unique nature of the medtech industry and its role in delivering patient care. We need to minimise disruptions to existing supply chains with many raw materials and component parts originating or transiting through the UK leading to uncertainty as we look to the future.
“Two-thirds of Irish Medtech members surveyed identified disruption of transit through the UK to the rest of the EU as the top Brexit concern. That’s along with half of companies saying they expect Brexit to negatively impact the cost of customs and the same number saying skills shortages in the areas of distribution, customs and logistics were a risk to their businesses.
“Another important issue is the mutual recognition of CE marks. Before going on the market, manufacturers in the EU are responsible for demonstrating that their products meet EU safety, health and environmental protection requirements. The CE mark symbolises that they meet these strict requirements and can be sold safely. Notably, with nearly half (43%) of Irish Medtech Association members using UK notified bodies to gain CE mark, mutual recognition is essential, notably for existing technologies on the market.
“All CE marked medical technologies granted by notified bodies in the UK or granted by an EU continent based notified bodies should continue to be recognised. This means that existing and valid CE marking certificates issued by UK Notified Bodies should continue to be recognised until their expiration date. We urge companies to contact their notified bodies to assess any potential impact should they have product on the UK market, or use a UK based notified body.
Irish Medtech Association Board Member, Cook Medical VP EMEA and MD Cook Medical Ireland, Bill Doherty said: “As an industry we have cautioned against regulatory divergence which one in four Irish Medtech members have identified as a concern in a recent Ibec survey. The new Medical Devices and IVD Regulation being implemented now in stages will only come fully into effect after the Brexit deadline. The UK played a key role in shaping the important Medical Device and IVD Regulations, since they were proposed in 2012. To now split the €110 billion European medtech market into two regulatory systems would be bad for business and patients alike.
Irish Medtech Association Chairman and Stryker Neuro, Spine, ENT & Navigation VP R&D David Tallon, said: “The Irish Medtech Association will continue lobby internationally to encourage EU leaders and policy makers to implement these recommendations to ensure the sustainable growth of the sector and patient safety. However, we urge companies not to delay in reviewing their business strategies or enacting contingency plans. While a recent survey of Irish Medtech members revealed that 91% of members have or are introducing contingency plans. Nearly one in ten said it was too early to plan.”
- Brexit and the Irish medtech sector report.pdf - 3,300 Kbytes