Kelly Calls for Immediate Review of Medical Device Regulation to Ensure Patient Safety and Supply of Life-Saving Devices

Sean Kelly, MEP for Ireland South and Leader of the Fine Gael Delegation in the European Parliament, has called for urgent review of the EU Medical Device Regulation (MDR), emphasizing the critical need to streamline the regulatory process to prevent shortages of essential medical devices.

“The MDR was established to improve patient safety after several high-profile scandals, the way it has been implemented has led to significant challenges. Small and medium-sized companies, in particular, are struggling to navigate the complex bureaucracy, and this has resulted in delays and shortages of life-saving devices,” Kelly said. “We cannot afford to wait any longer. The Commission must act within the first 100 days of the new term to revise this regulation.”

Kelly, who sits on the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI), stressed that while the initial intent behind the regulation was commendable, the red tape now in place is doing more harm than good. “Devices like cardiac catheters, which are vital for children with heart conditions, are becoming harder to produce and certify due to excessive regulatory burdens. We need a targeted revision to cut unnecessary bureaucracy while ensuring the highest safety standards are maintained.”

He added, “The European Commission has all the tools it needs to address these issues. The legal frameworks are in place; it is simply a matter of implementing them in a way that strikes the right balance between patient safety and the continued availability of these essential devices.”

Kelly called for a swift proposal from the Commission. “We need to fix what isn’t working, and we need to do it fast. We’re calling for a streamlined process, particularly for paediatric and orphan devices, without compromising patient safety.”

The Fine Gael MEP also highlighted that delays in addressing these issues are putting patient lives at risk. “If we delay further, the shortages will worsen, and patients across the EU, particularly children, will suffer. The Commission must present a concrete proposal that removes unnecessary hurdles and guarantees access to crucial devices.”

Kelly concluded: “The revision of the MDR is not just about industry; it’s about ensuring the safety and health of patients across Europe. We must act now, and I will continue to push for this essential reform.”