The European Commission and Members States are putting forward more steps to address the supply of medical devices in the EU. In this context, a new survey to monitor the availability of medical devices on the EU market is now available for manufacturers and authorised representatives.
Furthermore, from the latest EPSCO Council on Health, nine countries have supported an information note from the French delegation which expresses its worries that:
- The implementation of the MDR and the IVDR is affecting supply chains and may lead to the disappearance of the EU market on medical devices and IVDs;
- The EUDAMED database is not yet fully implemented, demanding quick solutions to address this issue.
As such, the French information note describes how the implementation of the medical devices and IVDs Regulations has imposed difficulties on economic operators to be compliant and that the risk of the lack of commercialization of several medical devices and IVDs is very present. It also identifies the burden small and medium-sized companies (SMEs) are going through. In addition, as EUDAMED is not yet fully functional, vigilance and post-market surveillance activities are hindered.
As shown in our previous posts, the number of MDR/IVDR certifications is still low, partly due to a delay by manufacturers in the application submission and preparedness. Thus, this information note reminds manufacturers that the existing MDR and IVDR legacy periods cannot be considered as a “grace period” but rather as an additional period to prepare to meet the Regulations’ requirements.
Overall, EU Member States highlighted the need for a more efficient regulatory system, especially regarding the certification of high-risk IVDs, to speed the transitioning of medical devices and IVDs and to achieve a solution for the EUDAMED system. In order to achieve this, some Member States called for EUDAMED modules to be gradually released and mandatory and to extend legacy transitional periods for IVDs, among other ideas.
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