Analysis of Express Import Authorizations for medical devices

By European Regulation 2017/745 of 5 April 2017, a medical device is defined as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended to be used, alone or in combination, for human beings for any of the following specific medical purposes:

– Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.

– Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability.

– Investigation, replacement, or modification of the anatomy or a physiological or pathological process or state.

– Providing information using in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations.

Express import authorizations cover the use of a medical device in specific patients (individual authorizations), outside of the clinical research setting with medical devices, using devices that do not bear the CE marking or are to be used under conditions of use different from those already authorized.

These authorizations shall only be considered when the physician, under their sole responsibility, deems it essential to use a medical device that does not comply with legislation (does not have a CE marking or has one for other indications, etc.) based on the particular and special characteristics of the patient, in the interest of their health and the absence of other alternatives on the market.

There is no “off-label” use for medical devices; therefore, they can only be used for the intended purpose for which they have been CE marked, or in the context of clinical research in which these devices are being assessed. If it is considered that the device could be suitable for another purpose or other indications, relevant clinical research should be carried out to obtain supporting data.

Legislation applicable to these authorizations

On 5 April 2017, two new European Regulations for medical devices were adopted, which eventually became applicable between 2020 and 2022. The main consequence of the updated regulation was the increase of regulatory requirements for medical devices to put safer devices with higher quality standards on the market.

This current legislation applies to:

Medical Devices under Regulation (EU) 2017/745 of the European Parliament and the Council
In vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 of the European Parliament and the Council

Necessary documentation to apply for express import authorizations.

For the assessment and subsequent granting of an express import authorization by the Spanish Agency of Medicines and Medical Devices, an application containing the documentation described below must be submitted:

A document stating the main information on the medical device to be used.
A clinical report in which the physician clearly justifies the need for such treatment for the patient and the absence of alternatives.
The signed agreement of the manager of the site where the treatment is to be applied.
The informed consent of the patient in which the medical device is to be used, indicating its exceptional nature, whether or not it has a CE marking, and whether it is to be used for an indication for which the device is not approved, if applicable.
The full name of a person to whom the express authorization should be addressed with a postal and e-mail address.