Earlier this month, a paper was published by the Irish and German delegations to the Council of the EU regarding the forthcoming implementation of the new regulation (EU) 2017/745 on medical devices (the "Regulation”) in May 2020. The Regulation represents a significant overhaul of the existing regulatory framework, and aims to ensure patients and public health are protected, while enabling safe access to innovative diagnostic and therapeutic technologies.
Under the new Regulation, notified bodies (“NBs”) will have increased responsibilities for the assessment and certification of medical devices, in contrast with the current system whereby over 80% of such devices are self-declared by the manufacturer. Concerns about the capacity and availability of NBs to handle these demands have been frequently voiced by industry stakeholders, particularly as the number of NBs is expected to decrease by the time the Regulation takes effect.
In addition to NB capacity issues, the paper highlights likely challenges with system requirements, infrastructure, and secondary legislation necessitated by the Regulation, as well as the current lack of clarity and available guidance on the new regulatory system. Despite the lengthy implementation period, businesses in the sector should urgently consider their readiness for compliance with the new requirements.