Yuri Ceragioli -

The EU Regulation 2017/745 on medical devices (MDR) came into force in May 2021 but there are still several points of the MDR that are not fully applicable or are applicable only to some devices and companies and there are some points that are not fully clear, in particular as concerns the impact of the MDR on the local requirements.

The Italian MoH has recently issued an official communication relevant to some aspects of the MDR. In particular, as concerns the local requirements the Italian MoH:

  • confirmed that the Italian Medical Device Database is still working and companies that intend to put their medical devices on the Italian market have to register the devices on the Italian Medical Device Database
  • confirmed that all the local procedures foreseen for the request of authorization of medical device promotional material addressed to the general public are still applicable
  • clarified that manufacturers of custom-made medical device certified according to the MDR, must notify to the Italian MoH the list of devices put into the Italian market

Regulatory Pharma Net is available to provide your company with any updates on the medical device regulatory framework  and to assist on all regulatory needs related to medical devices.

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