Etiquetado e Instrucciones de uso: Fundamentos del MDR para Productos Sanitarios

In the European Union, a medical device is not legal to place on the market with just the device in a box. It must carry the right labeling and an instructions for use, and these must meet the Medical Device Regulation. A buyer who imports medical equipment into the EU needs to understand what the labeling and the instructions for use must show, because a device with the wrong labeling is a compliance risk and a registration risk. This guide explains the MDR basics of labeling and instructions for use.

Why labeling is a legal requirement

The Medical Device Regulation sets out what information a device must carry on its label and in its instructions for use. This is not optional, because the label is how a user, a patient and a regulator know what the device is, who made it, and what it is for. Without the required labeling, a device cannot be shown to comply and cannot lawfully be placed on the market in the EU. Labeling is the first thing a regulator and a notified body check.

What the label must show

The label typically carries the manufacturer name and address, the device name, the intended purpose, the batch or serial number, the UDI, the sterile status where relevant, and the storage and handling conditions. It also carries the CE mark and the manufacturer’s responsibility symbol. The exact list depends on the device and on whether it is sterile or non-sterile. Each field has a requirement, and a missing one is a finding in an audit.

What the instructions for use must cover

The instructions for use are the way a manufacturer communicates how to use the device safely. They must cover the intended purpose, the clinical benefit, the indications, the contraindications, the warnings and precautions, the preparation, the steps for use, and the maintenance. The instructions must be in the language required by the market where the device is sold. This is where a device that is used by a professional or by a patient is clearly distinguished.

The level and the classification

The level of the instructions for use depends on the class of the device. A lower-class device that is simple and used by a layperson may need a different set of instructions than a higher-class device used by a professional. The rules set whether a device needs instructions at all, and where the risk requires more detail. Understanding the classification is the first step to knowing the labeling requirement. See how CE MDR compares to MDD for the change in the rules.

UDI and the registration link

The label also connects the device to the registration. The UDI identifies the device in the EU database, and the information entered there must match the label. A device cannot be registered with data that does not match what is on the label. This link between label, UDI and database is a common area for error in an import. See how a EUDAMED registration role and a free sale certificate fit the picture.

The authority and the standard

The labeling and the instructions for use requirements are set by the EU medical device regulation and are interpreted through the guidance published by the European Commission. The European Commission publishes the regulations and the guidance that define what a device must show on the label, so it is the reference a manufacturer and a buyer should use to confirm compliance.

Qué hacer

For a buyer, confirm that the device carries the required CE mark, that the label contains the required fields, that the UDI matches the registration, and that the instructions for use are correct and in the right language. Ask the manufacturer for the labeling and the instructions as part of the compliance pack, and verify them before the device ships.

Para la gama de equipos médicos detrás de esta guía, consulte nuestro escaparate de productos página.

Preguntas frecuentes

¿Por qué es importante el etiquetado bajo el MDR?

El Reglamento de productos sanitarios establece lo que un producto debe mostrar en su etiqueta y en sus instrucciones de uso. Sin el etiquetado requerido, no se puede demostrar que un producto cumple y no puede comercializarse legalmente en la UE.

¿Qué información debe mostrar la etiqueta?

La etiqueta muestra el fabricante, el nombre del dispositivo, el uso previsto, el número de lote o de serie, el UDI, el estado estéril cuando corresponda, las condiciones de almacenamiento y manipulación, y el marcado CE.

¿Qué deben cubrir las instrucciones de uso?

Cubren el propósito previsto, las indicaciones, las contraindicaciones, las advertencias y precauciones, la preparación, los pasos de uso y el mantenimiento. Deben estar en el idioma requerido.

How does the device class affect the labeling?

The level of the instructions and the labeling depends on the device class. A higher-risk device used by a professional has different requirements than a simple device used by a layperson.