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In the context of the evaluation of the European Medical Device Regulation (Regulation (EU) 2017/745; MDR) and In Vitro Medical Device Regulation (Regulation (EU) 2017/746; IVDR), the European Social Insurance Platform (ESIP) acknowledges problems in the transition to the current legal framework, while also stressing that the implementation of the MDR and IVDR remains a necessary and important step towards improving patient safety and the quality of treatment with medical devices.
A thorough formal evaluation of the MDR and IVDR in all their legislative components is necessary, before considering further legislative changes to potentially lower the regulatory requirements. Information about potential market withdrawals and the resulting shortages should be incorporated as a central element of the planned evaluation.
In the meantime, ESIP recognises the need to swiftly implement legislative mechanisms to facilitate access to medical devices intended for the treatment of rare diseases ('orphan medical devices'). The following actions should be considered to establish a dedicated legal framework for orphan medical devices:
Introduce a clear definition of orphan medical devices, based on the recommendations of the Medical Devices Coordination Group (MDCG)
Establish a central authority responsible for authorising orphan medical devices, while their clinical evaluation will remain in the remit of Notified Bodies (NB)
Define criteria for the clinical evaluation and approval requirements for orphan medical devices including post-marketing plans for the collection of the missing clinical data
Establish diseases-specific central registries for orphan medical devices to ensure appropriate and timely collection of clinical data for orphan medical devices
Consider financial and technical support to highly specialised small and medium-sized enterprises (SMEs) developing orphan medical devices