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Obligations of Medical Device Importers in the EU and Spain
 

The entry into force of the MDR has brought many changes in the obligations and responsibilities of medical device importers.

In this article, we will analyze their responsibilities and obligations both at the level of the European Union and in Spain.

The importers of medical devices, that is, those individuals or companies established in the EU that introduce a product from a third country into the EU market, have the following obligations:
In Spain, they need the Import Facility License granted by AEMPS. They must have a Technical Manager who will ensure the import and release of the products. They may have sampling procedures for reception and release. They are responsible for checking all imported medical devices:
That the product has the CE marking and the EU declaration of conformity has been drawn up; That the manufacturer is identified and has properly designated an authorized representative; That the manufacturer is registered in EUDAMED (when applicable). That the product is labeled in accordance with this Regulation and accompanied by the necessary instructions for use, if applicable; That the manufacturer has assigned a unique identifier (UDI) to the product and the UDI-DI-BASIC appears in the EU declaration of conformity. They must register in EUDAMED Indicate on the product or its packaging or in a document accompanying the product:
their name, registered trade name, or trademark, their registered office and address where they can be contacted and located. Ensure that the label information provided by the manufacturer is not obscured by other labels. Ensure compliance with the storage and transport requirements of the products for which they are responsible. Maintain
a record of complaints, Record of non-compliant products Record of recalls and withdrawals of products, Provide the manufacturer, authorized representative, and distributors with any information they request to investigate complaints. When identifying a product introduced into the market as non-compliant and posing a serious risk, notify the competent authorities. (specific procedures for incident management and surveillance). When identifying a product introduced into the market as non-compliant, notify the manufacturer and authorized representative to take appropriate corrective measures (withdraw the product, correct it, etc.). Specific procedures for incident management, surveillance, and traceability). If they have received complaints, they will notify the manufacturer and authorized representative to act accordingly. (Complaint management procedure). Maintain documentation of medical devices for at least 10 years and 15 for implantables.
 
The Operating License for Medical Device Importers
Regarding the Prior Operating License for Facilities granted by AEMPS, various documentation must be submitted for it to be granted.

To begin with, it is necessary to provide the layout of the facilities that will receive the goods along with an explanatory report of each area of the layout. This report must specify the machines, tools, or equipment available and involved in the import or preservation process of medical devices in each area.

Additionally, administrative data of the company must be provided, such as the deeds in which the corporate purpose must be related to the import of medical devices; the company’s CIF and the responsible person’s DNI.

Regarding the organization of the company, a functional organization chart must be presented, which must include the figure of the technical manager, along with an explanation of the functions and responsibilities of each position.

As mentioned, the technical manager is a key figure to ensure the safety of the product, in this case, that all documentation related to the product, the import process, and preservation are correct. For this reason, documents of designation of the technical manager, a contract with them, their responsibilities, university degree, and DNI must be provided. All correctly signed.

Finally, the submission of procedures related to the obligations required of importers is required, such as procedures for complaints and incidents, the surveillance system, product and supplier verification before purchase, import, reception, and product traceability and release.

At deviCE Sistemas we know the necessary processes for importers to obtain the operating license and demonstrate correct and safe processes.