COVID-19: PRESSURE POINTS: Order SND/326/2020, of 6 April, which establishes special measures to grant prior operating permits for facilities and to use certain medical devices lacking CE certification as a result of the medical crisis linked to the COVID-19 outbreak (Spain)

The Order establishes a number of special measures for medical devices listed in the annex to the Order, surgical facemasks and surgical gowns:

• Permit.  A prior operating permit for facilities (as established in article 9 of Royal Decree 1591/2009, of 16 October, which regulates medical devices) will still be required to manufacture medical devices necessary in the fight against the COVID-19 pandemic and the requirements established in that provision must be met. However, the Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios) may, upon receipt of an application from the interested party, grant an exceptional permit or temporarily modify an existing permit to manufacture medical devices necessary to protect public health during the COVID-19 health crisis.
• Guaranteed supply. The Spanish Medicines Agency has been called upon to issue as many express authorisations are possible to use devices necessary to meet the needs generated by the COVID-19 outbreak and which have not undergone the evaluation procedures as required by article 13 of Royal Decree 1591/2009, of 16 October, all with the aim of safeguarding public health.
• Safety standards. Exceptionally, depending on the product in question and after having assessed the guarantees that the manufacturer is offering, the Spanish Medicines Agency may establish which health safety standards of those established in article 4 of Royal Decree 1591/2009, of 16 October, are applicable.
• Liability. Any liability that may ultimately be placed on the administration as a result of the exceptional prior operating permit, permits for the use of devices lacking CE certification, in application of article 15 of Royal Decree 1591/2009, of 16 October, or the safety standards not required in respect of a device shall be borne by the General State Administration, in accordance with the applicable provisions of Law 40/2015, of 1 October, on the Legal Regime applicable to the Public Sector, provided that the medical device has been delivered to the Ministry of Health with the aim of attending to those affected by the COVID-19 pandemic or to help to control that pandemic, where the person or entity authorised to manufacture the medical device has not received any profit for doing so.