Customized Medical Device
Customized Medical Devices are those specially manufactured according to a medical prescription for a specific person based on their anatomy, special needs, or condition.In the case of a Customized Medical Device, it is the responsibility of the requesting healthcare professional to ensure that the specific design characteristics of the product are suitable for the person.In Spain, manufacturers of Customized Medical Devices do not need to obtain the preliminary operating license for facilities granted by AEMPS, but rather an authorization or Operating License from the Autonomous Community where they are the manufacturer. However, once the Customized Medical Device is marketed, it must be reported to AEMPS.
Manufacturers of this type of Medical Device must have an organizational structure capable of ensuring the quality of the products and the execution of the relevant procedures and controls.They must also have suitable facilities, procedures, equipment, and personnel according to the activities and products involved. Additionally, like manufacturers of serial medical devices, they must have a Technical Manager whose qualifications demonstrate appropriate expertise based on the products they oversee, who will directly supervise the activities carried out by the company.
Manufacturers of Customized Medical Devices must have a documentary archive that stores the documentation generated with each manufactured product and maintain a record of all products available for use within the national territory.This documentary archive must include the following documentation:2 Documentation related to the quality system and specifications of each manufactured product, including labeling and instructions for use.2 Documentation that allows tracking of products within the production and control chain, as well as their unequivocal identification.2 Documentation related to the experience gained from the use of the products, including that derived from the surveillance system, as well as complaints and returns.2 Documentation that allows understanding of the design, manufacturing, and performance of the product, so that its compliance with applicable regulatory requirements can be evaluated.2 Documentation related to marketing, which will contain the product’s identifying data (trade name, model, serial number), the manufacturing date, and the shipping, supply, or delivery date.
Similarly, manufacturers of Customized Medical Devices must have a Person Responsible for Regulatory Compliance who can demonstrate their expertise by having at least two years of professional experience in a relevant field of manufacturing.These manufacturers must comply with the Regulation (EU) 745\/2017 MDR as applicable to them; however, they cannot bear the CE Marking, and the Declaration of Conformity will not be the same as for serially manufactured products.