The turbulent times we are experiencing, when the demand for sanitary products has skyrocketed, have highlighted the importance of having standards that guarantee the quality of these products.

What do we call medical devices?

A medical device is defined as “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by the manufacturer specifically for diagnostic and/or therapeutic purposes and that are instrumental in its proper functioning, intended by the manufacturer to be used in humans for the purposes of:

• Diagnosis, prevention, control, treatment or relief of a disease.
• Diagnosis, control, treatment, relief or compensation of an injury or deficiency.
• Research, substitution or modification of anatomy or a physiological process.
• Regulation of conception, and that it does not exercise the principal action desired to be obtained inside or on the surface of the human body by pharmacological, immunological or metabolic means, but to whose function such means may contribute.

(Royal Decree 1591/2009)

Medical devices are regulated by common standards across the European Union, and CE marking by the manufacturer certifies that the product complies with all this legislation. As is the case with work equipment, a medical device that does not have this seal cannot be marketed within the European market.

What does the health CE guarantee?

The CE sanitary marking guarantees that a product has been manufactured and is intended for use in accordance with the safety and quality regulations established by the European Union. A product with this mark will have the appropriate technical documentation, will have been tested and evaluated, will comply with the relevant legislation and will have a quality assurance system.

How do you get the health certificate?

The medical CE marking It is a complex process involving numerous regulations and directives. For the process to be efficient, it is very useful to have the advice and support of a company with extensive experience in the management of sanitary CE marking, such as Grupo TICE.

What steps do we need to follow to obtain CE marking for medical devices?

First of all, the product must be classified. Depending on the classification, different regulations will be considered for obtaining certification. The next step will be to obtain the manufacturing or import licence, in the case of seeking to market a product that has not been manufactured by us. Subsequently, the clinical evaluation is carried out and, following that, laboratory tests. At this point, the product's ‘Technical file’ is compiled, and finally, the necessary quality system is implemented to comply with all regulations relating to medical devices.

After the satisfactory resolution of all these phases, the CE sanitary mark is obtained.