EU Parliament Pushes for MedTech Regulation Revisions

The European Parliament is urging the European Commission to address significant challenges in implementing the Medical Device Regulation and In Vitro Diagnostic Regulation. These regulations are currently causing delays in device certification and approval, particularly impacting SMEs and resulting in restricted patient access to essential technologies. The Parliament emphasises the need for systematic revisions to the legislation to tackle these pressing issues effectively.

The call for action arises from mounting difficulties in the regulatory landscape, where inconsistent procedures across EU notified bodies lead to unpredictable timelines for device certification and market access. These hurdles have critically affected SMEs, which struggle to navigate the complex regulatory framework. The EU Parliament’s resolution also highlights the need for transparent and binding timelines for conformity assessments, aiming to streamline processes and reduce unnecessary administrative burdens. Prominent Parliament member Peter Liese is advocating for prompt legislative changes, while stakeholders like MedTech Europe support the Parliament’s initiative.

As the pressure for reform intensifies, the European Parliament’s resolution seeks to pave the way for more efficient and transparent regulatory processes in the medtech sector. While urgency is prioritised, stakeholders, including Věra Jourová from the European Commission, emphasise the importance of a data-driven approach in formulating these changes. The outcome of this initiative could greatly influence the medtech industry’s regulatory environment, ultimately enhancing patient access to innovative technologies.

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