Products are classified according to the rules contained in Annex IX of Royal Decree 1591/2009.

In clinical research with medical devices there are different situations that must be clearly differentiated in order to know the requirements applicable to each of them:

1) Medical devices without CE marking (Article 62 of the Regulation).

2) Medical devices with CE marking. Use according to their instructions and the approved intended purpose.

3) Medical devices without CE marking or with marking, but regardless of their intended purpose.

In accordance with current legislation on medical devices ( Regulations (EU) 2017/745 on Medical Devices and (EU) 2017/746 on In Vitro Diagnostic Medical Devices ), these products may circulate freely within the Community territory provided they are provided with the CE marking.

Serious incidents associated with a medical device or with the information provided with the medical device must be reported and the incident is such that it has caused or, if it occurs again, could cause:

• Death
• A serious deterioration in the health of the patient, user or other person, such as:
  • Life-threatening illness or injury.
  • Permanent impairment of a bodily function or permanent damage to a bodily structure.
  • A process that requires medical or surgical intervention to prevent permanent impairment of a bodily function or permanent damage to a bodily structure.
• A serious threat to public health.

A Field Safety Note ( FSN ) is therefore a communication to customers and/or users sent by the manufacturer or a representative in relation to a Field Safety Corrective Action .

The FSCA may include:

• The return of the medical device to the supplier.
• Product modification.
• The exchange of the product for another.
• The destruction of the product.
• The adaptation of the product by the buyer according to the modification or design change made by the manufacturer.
• The manufacturer's recommendations regarding the use of the product or the monitoring of patients in whom the product has been used (for example, when a product has been discontinued or withdrawn from the market but is still in use, as is the case with implants, or changes in the analytical sensitivity or specificity of diagnostic medical devices).

Marketing and commissioning in Spain of medical devices and in vitro diagnostic medical devices

Any economic agent that markets products in Spanish territory, other than custom-made products, must be included in the Marketing Registry of the Spanish Agency for Medicines and Health Products. This registration must be carried out prior to the marketing activity through the channel enabled for this purpose in the electronic headquarters of the Spanish Agency for Medicines and Health Products.