EAAR (European Association of Authorised Representatives) co-signed the joint discussion paper “Future governance of medical technologies in Europe’’ together with MedTech Europe, AESGP, COCIR, EUROM, and FIDE. The joint paper advocates for a reform of the EU regulatory framework for medical devices and in vitro diagnostic medical devices.
Proposed approach to MDR and IVDR challenges
Centralisation: a single, patient-centric structure ensuring timely access to safe devices while fostering innovation and competitiveness.
Accountability: the central governance should ensure regulatory consistency and alignment with other EU regulations.
Notified bodies: the decentralised Notified Body system remains essential but should be improved for efficiency, cost-effectiveness, and predictability.
Empowered governance: the new authority must have clear roles, adequate resources, and specialised expertise.
Impact assessment: a review should determine the best setup for a sustainable and robust regulatory system, sufficient budget and empowerment, transparent processes, reduced administrative burdens, a better collaboration with stakeholders, and time as well as cost efficiency.
Eight years of MDR and IVDR
Over the eight years into the EU medical device regulations (MDR and IVDR), structural challenges have emerged. The system lacks a central authority to ensure timely access to medical devices and IVDs, address inefficiencies, and promote the EU regulatory framework globally. Urgent reforms are needed to create a governance system that efficiently supports the availability of safe and innovative medical technologies while fostering innovation in the sector.
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