Irish Medtech Association Senior Executive Dr Áine Fox cautioned that: “While industry has invested heavily in making changes to their businesses and training staff to be adequately equipped to comply with the new EU Medical Devices and IVD Regulations, the regulatory infrastructure is not ready. After more than half a decade of development and negotiation the EU has underestimated what is needed to ensure patients continue to have access to the 500,000 medical technology product groups that are currently on the global market after the regulations come fully into operation by the end of May 2020 for medical devices and May 2022 for invitro diagnostics.
“Medical devices are used to diagnose, monitor and treat patients. Before they can go onto the market manufacturers must demonstrate that their products meet EU safety, health and environmental protection requirements. The Irish Medtech Association and its members provided significant feedback and comment during development of the new regulations to reflect the evolution of this innovative sector, which saves and improves lives. But businesses are now being encouraged to develop contingency plans.
“There has been an alarming 32 per cent drop in the number of designated notified bodies in the EU between 2012 and 2018. This trend must be reversed urgently as these organisations are vital to review medical devices for certification in an independent and impartial manner. Because the implication of restricted market access is that hospitals and doctors will no longer have the same life-saving technologies available to them to treat patients.”
Irish Medtech Association Chairman and Stryker Neuro, Spine, ENT and Navigation VP R&D David Tallon added: “This problem has been aggravated further by the ongoing Brexit negotiations, which not only risks splitting the EU regulatory system and €110 billion market in two, it may also deny businesses access to notified bodies they’ve used in the past. As many as 43 per cent of Irish Medtech members rely on UK notified bodies to gain certification. We are calling on the EU and UK to ensure the mutual recognition for existing medical technologies and on the EU to find a solution to address the shortfall of notified bodies needed to implement the new regulations.”
A recent survey published by the Association found 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.
Irish Medtech Association Director Sinead Keogh said: “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 per cent) of Irish Medtech Association members using UK notified bodies to gain the 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 a product on the UK market, or use a UK-based notified body.”