Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties.

The prior public consultation is the initial stage of development of the Spanish Ministry of Health’s regulation of medical devices. This process allows stakeholders to provide input, i.e. there is not a draft text of the regulation yet.

With the entry into application of (EU) 2017/745, the Medical Device Regulation ("MDR"), just around the corner, the Ministry of Health's goal is to adjust national regulations on medical devices (Royal Decree 1591/2009) and active implantable medical devices (Royal Decree 1616/2009) to the provisions of the MDR, as well as to keep, develop, and implement those aspects that the MDR entrusts to member states.

As expected, the idea is to repeal the Royal Decrees currently in force and bring together in a single legal text the provisions relating to medical devices and active implantable medical devices.

In accordance with the prior public consultation, the new Spanish regulation will address, among other issues, the following:

  • Requirements and procedures for (i) the regulation of “in house” medical devices manufactured and used in a health facility; (ii) the regulation of the reprocessing of single-use medical devices; and (iii) the regulation of implant cards.
  • Incorporation of a national registry of distributors.
  • Regulation of a language regime.
  • Requirements for conducting clinical investigations.

Interested parties have until 20 March, 2020 to submit the contributions they consider appropriate.