Publications

EUROPEAN UNION

1. European Commission proposes one-year postponement for application of the medical devices regulation: see our alert dated April 8, 2020, in which we discussed this issue.

2. Export authorization for certain types of medical protective equipment outside the European Union: in Commission Implementing Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorisation (amended by Commission Implementing Regulation (EU) 2020/426 of 19 March 2020), the European Commission decided to make the exportation of certain medical protective equipment (listed in the annex to the Regulation) outside the European Union temporarily subject (for six weeks from publication of the Regulation) to authorization, whether or not it originates in the European Union.

This authorization is not applicable, however, for exportations to Norway, Iceland, Liechtenstein and Switzerland, to the overseas countries and territories listed in Annex II to the Treaty on the Functioning of the European Union, and to the Faroe Islands, Andorra, San Marino and Vatican City.

DOMESTIC LEGISLATION

1.Measures adopted in recent weeks to tackle the economic and social impact of COVID-19 with particular implications for the healthcare and pharmaceutical industry.

In our alert dated March 23, 2020 we analyzed the key information to be noted by companies in the sector.

2. Lifting of fee for authorization procedures for clinical trials with medical devices and for prior operating permit procedures for manufacture of medical devices, all related to the COVID-19 health crisis:

Additional provision six of Royal Decree-Law 13/2020, of April 7, 2020, adopting certain urgent measures in relation to agricultural employment, for the duration of the public health emergency caused by COVID-19, has lifted the fees determined in:

1. caption 8.12 of Group VIII in article 123.1 of the Spanish Medicines Law in relation to the prior operating permit procedure, with respect to any exceptional permits granted by the AEMPS (Spanish Medicinal Products and Medical Devices Agency) for the manufacture of any medical devices needed to protect public health and to ensure supplies in the COVID-19 health crisis; and
2. caption 8.19 of Group VIII in article 123.1 of the Spanish Medicines Law in relation to the authorization procedures for clinical trials with medical devices, conducted in relation to the health crisis caused by COVID-19.

3. Special measures for the grant of prior operating permits for facilities and for bringing into use certain types of medical devices without the CE marking as a result of the COVID-19 health crisis.

In Order SND/326/2020, of April 6, 2020, establishing special measures for the grant of prior operating permits for facilities and for bringing into use certain types of medical devices without the CE marking as a result of the health crisis caused by COVID-19 (Order SND/326/2020), the Health Ministry establishes, among other provisions, the special measures listed below in relation to surgical masks and surgical gowns, as a result of the health crisis caused by COVID-19.

1. Prior operating permit for facilities: the AEMPS will be able to grant an exceptional permit or a temporary amendment of the existing permit for the manufacture of medical devices needed to protect public health in the health crisis caused by the COVID-19 virus.
2. Guaranteeing supplies: the AEMPS is called upon to issue as many express authorizations as it can for the use of any products required to meet the needs created by the COVID-19 virus and which have not been met with the conformity assessment procedures specified in article 13 of Royal Decree 1591/2009, of October 16, 2009, on medical devices, all of the above in the interests of protecting public health.
3. Liability: any financial liability that may be attributed by reason of the exceptional prior operating permit for facilities or the use of products without the CE marking will be assumed by the Spanish public administration service (Administración General del Estado), provided the medical device has been delivered to the Health Ministry to attend to people infected by the COVID-19 virus or help control it, and no type of business profit has been obtained by the individual or legal entity authorized to manufacture it and bring it into use or by any others who participate in that process.
4. List of products falling under Order SND/326/2020: the AEMPS is authorized to include new products among those falling under the order depending on the evolution of the health crisis.
5. Period of validity: the provisions in Order SND/326/2020 will be applicable until the end of the state of emergency declared by Royal Decree 463/2020, of March 14, 2020, and, where applicable, of its successive extensions.

4. Clinical diagnosis centers made available to the autonomous communities

In Order SND/344/2020, of April 13, 2020, establishing exceptional measures to reinforce the National Health System and contain the health crisis caused by COVID-19, the Health Ministry determines that the autonomous communities will have available to them any privately-owned healthcare institutions, services and establishments located in the autonomous community concerned that are not providing services in the National Health System, together with their staff.

5. Exceptional measures to guarantee access for the population to products recommended for use as measures of hygiene to prevent contagion by COVID-19.

In Order SND/354/2020, of April 19, 2020, the Health Ministry defines the procedure for determining the maximum retail selling price for medical devices and for any products needed to protect the health of the population against COVID-19, determines the information that must be provided on the labelling of hygiene masks, and defines the conditions on which retail sales by unit are allowed to be made of surgical masks that do not have individual packaging.

The order came into effect on April 19, 2020, the date of its publication in the Official State Gazette -BOE- and will remain so until a Health Ministry order so determines.