Prior license to operate a medical device
In accordance with Royal Decree 192/2023, natural or legal persons engaged in the manufacture, manufacture to third parties, import, grouping or sterilisation of medical devices and the facilities in which such activities are carried out will require a prior operating licence granted by the AEMPS.
The establishments and activities of natural or legal persons engaged in the manufacture of custom-made products shall require a prior operating licence granted by the health authorities of the corresponding Autonomous Community.
The prior operating licence will cover both its own and contracted facilities and activities, with special attention to those carried out by critical subcontractors, and may even require an audit of their facilities.
Any modification of the conditions under which the license was granted must be previously authorized by the issuing body.
Application requirements:
- Have an organizational structure capable of guaranteeing quality.
- Availability of facilities, procedures, equipment and adequate personnel.
- Availability of a technical manager.
- Availability of a document archiving system (technical file and other required documents).
- Availability of a person responsible for the surveillance system, typically the company’s technical manager.
- Availability of a procedure for applying restriction or monitoring measures.
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