Customized Sanitary Product.
MDR e IVDR .
Customized Sanitary Product.
Tailor-made medical devices are those specially manufactured according to a medical prescription for a specific person based on his anatomy, special needs or condition.
In the Customized Medical Device, it is the responsibility of the requesting healthcare provider to ensure that the specific design features of the product are appropriate for the individual.
In Spain, manufacturers of Custom-Made Medical Devices do not have to obtain the Prior License to operate facilities granted by AEMPS, but an authorization or Operating License from the Autonomous Community in which it is a manufacturer. However, once the Custom-Made Medical Device has been marketed, the AEMPS must be notified.
Manufacturers of this type of Medical Devices must have an organizational structure capable of guaranteeing the quality of the products and the execution of the appropriate procedures and controls.
Likewise, they must have adequate facilities, procedures, equipment and personnel according to the activities and products in question. And, as well as the manufacturers of serialized medical devices, they must have a Technical Manager whose qualification accredits an adequate qualification according to the products he/she is in charge of, who will directly supervise the activity carried out by the company.
The manufacturers of Customized Medical Devices must have a documentary file that stores the documentation generated with each product manufactured and keep a record of all the products available for use in the national territory.
This documentary archive shall have the following documentation:
• Documentation relating to the quality system and specifications of each product manufactured, including labeling and instructions for use.
• Documentation that allows products to be tracked within the production and control chain, as well as their unequivocal identification.
• Documentation relating to the experience gained from the use of the products, including that derived from the monitoring system, as well as complaints and returns.
• Documentation that provides an understanding of the design, manufacture and performance of the product so that conformity with the applicable regulatory requirements can be assessed.
• The documentation relating to marketing, which shall contain the product’s identification data (trade name, model, serial number), the date of manufacture, the date of shipment, supply or delivery.
Likewise, manufacturers of Customized Medical Devices must have a Person Responsible for Regulatory Compliance who can demonstrate his/her expertise as such by accrediting professional experience of at least two years in a relevant field of manufacturing.
These manufacturers have to comply with Regulation (EU) 745/2017 MDR, in all that applies to them, however, they will not be able to carry the CE Marking nor will the Declaration of Conformity be the same as mass produced products.
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