Changes from resolution motion to resolution motion joint

Removed16. Calls for the establishment of a central governance structure or medical device office within the Commission’s Directorate-General for Health to centralise responsibilities and powers in the designation management and surveillance of notified bodies, the harmonisation of administrative practices, the development of guidance on the implementation and application of EU regulations applicable to medical devices and in vitro diagnostic medical devices, and the coordination of the applicability of other EU regulations to medical devices and in vitro diagnostic medical devices with other directorates-general of the Commission;

Added11. Calls on the Commission to facilitate the collection of clinical data from existing national registries for small patient groups treated or diagnosed with orphan and paediatric devices, in compliance with the protection of personal data; recognises the challenges faced by various SMEs in adapting to the legal frameworks; invites the Member States and the Commission to develop specific measures to support SMEs, including the provision of model application documents and forms, regulatory guidance and other assistance to reduce the costs and complexity of the regulatory frameworks;

Removed17. Calls for a stronger and more harmonised post-market surveillance system that makes use of real-world data and patient feedback to identify and address safety issues more rapidly; encourages, therefore, the establishment of a centralised EU database for post-market data as part of the module for vigilance and post-market surveillance of the European Database on Medical Devices that ensures transparency and facilitates cross-border cooperation in monitoring device performance and addressing risks;

Added12. Calls on the Commission to continuously monitor the availability of devices, particularly the last remaining devices of particular types, and to take appropriate action to keep them available in the EU market; in this regard, calls for an urgent full implementation of EUDAMED, which will enable information about medical devices and manufacturers to be processed to enhance transparency, provide better access to information for the public and healthcare professionals, and enhance coordination between Member States;

Removed18. Calls on the Member States to inform the central governance structure or office of the results of notified body audits and specific instructions issued to notified bodies concerning administrative practices and conformity assessment procedures; highlights the need for this central governance structure or office to coordinate Member States’ market surveillance and vigilance activities in order to enhance the efficiency of market surveillance across the EU;

Added13. Emphasises that any new rules or changes to existing rules must come with an appropriate transition period to allow all stakeholders sufficient time to adjust to the changes;

Removed19. Urges the Commission to strengthen international cooperation on the simplification, assimilation and mutual recognition of national certification processes, in particular with the US Food and Drug Administration;

Removed20. Calls for an appropriate transition period before the implementation of new rules; emphasises the need to set a transition period before the enforcement of new regulations that would allow enough time for manufacturers to prepare and for the necessary institutional infrastructure to be established; notes that this measure ensures that all stakeholders are fully equipped to meet the regulatory requirements without compromising the overarching objectives of the legislation;

14. Instructs its President to forward this resolution to the Council, the Commission and the governments and parliaments of the Member States.