Sinead Keogh
Ibec Director, Medtech and Engineering
Decisive action from the EU is needed to ensure new medical devices regulation functions as intended.
There are more than 500,000 different types of medical technologies on the market ranging from glasses and wheelchairs to pacemakers and MRI scanners.
Medtech is arguably the most innovative sector in Europe with more than 14,200 patent applications filed with the European Patent Office (EPO) in 2020, representing a 2.6% growth compared with the previous year.
This is not only due to the diversity of products, but also the short product lifecycle of 18-24 months which is underscored by a commitment to delivering improved medtech for both healthcare professionals and patients.
Ensuring regulations support innovation and access
To get into the health system, manufacturers must demonstrate that medical technologies meet EU-wide safety and performance requirements. These are assessed by notified bodies who award CE marks.
The new EU Medical Device Regulation (MDR), which came into effect 26 May 2021, represents the greatest change for the regulatory system in over 20 years. While the medtech industry is a proven supporter of the EU MDR’s goals, and has invested significantly into the transition process, major challenges still need to be addressed:
- Tackle certification bottleneck by addressing notified body capacity and facilitating early dialogue for new devices.
- Avoid an innovation backlog and retiring legacy devices with appropriate evidence requirements.
Competitiveness in changing global landscape
The EU has historically been a location of choice for the launch of new medical technologies and Ireland has benefited from this with investments. However, a lack of predictability relating to MDR coupled with an increasingly predictable regulatory environment in other markets, such the US under the Food and Drug Administration (FDA), means that the EU is no longer seen as the most attractive location to develop and launch new medical technologies.
This issue risks being further compounded by some investors choosing not to invest in early-stage companies with plans to launch new products in the EU given the lack of business predictability.
As the global trading environment becomes more competitive, the ability to innovate will help business to build resilience.