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Who is a Third-Party Product Manufacturer?
Basically, individuals or legal entities that perform the Complete Manufacturing of products for third parties.
The new Royal Decree 192/2023, of March 21, regulating medical devices does not explain what Complete manufacturing means, but the AEMPS Circular regulating operating licenses, the new Instruction PS1/2023 published by AEMPS, gives some insight.
It mentions that Complete Manufacturing is performing all stages of manufacturing and that, performing any of the production stages of a product for third parties excludes you from obtaining the license.
What products does it refer to?
The aforementioned new R.D. 192/2023 regulating medical devices identifies Products as:
Medical devices.Accessories for medical devices.Annex XVI MDR Products, that is, those without a medical purpose, but aesthetic, to which the Regulation applies.Equipment and instruments for tattooing, permanent and semi-permanent skin makeup using invasive techniques. Therefore, manufacturers who perform the complete manufacturing of these products for third parties must obtain the operating license granted by AEMPS. Why the new Spanish RD on medical devices?
Although the MDR is directly applicable in the countries of the European Union, it is necessary to regulate at the national level the aspects that the European standard leaves to the regulation of each Member State.
With that premise, the Royal Decree 192/2023, of March 21, regulating medical devices, was published on March 21, 2023.
One of the novelties of the new Spanish R.D. on medical devices is the establishment of the need for a prior operating license also for manufacturers of Third-Party Products, a figure that does not exist in the MDR, and which is now regulated at the national level.
Prior operating license for third-party manufacturers
R.D. 192/2023 in its Article 7. Prior operating license for facilities, establishes that:
“The prior operating license will also be required for those individuals and legal entities that perform the complete manufacturing of products for third parties” If you are a company that manufactures complete medical products for third parties at deviCE Sistemas, we can assist you in the entire process of obtaining this prior operating license, as well as guide you through all the necessary steps to obtain it, and meet all the requirements requested by AEMPS.CALL US AND WE WILL HELP YOU WITH THE PROCEDURES!
The requirements for this prior operating license for third parties are established in the recently published INSTRUCTION PS 1/2023 ON THE PROCEDURE FOR PRIOR OPERATING LICENSE FOR MEDICAL DEVICE FACILITIES.
Basically, the requirements to obtain the license are the same as those that the legal manufacturer of the product must meet: quality management system and organizational structure, facilities, equipment, personnel, technical manager, and so on.
Among these obligations, it is worth highlighting the need to have a Technical Manager. Another difference with a “legal” manufacturer is that the third-party manufacturer does not need a figure responsible for regulatory compliance.