Spanish guidance on operating licences prior to the installation of medical devices
The Spanish Competent Authority released on the 1stof April 2022 a new guidance detailing the procedure to obtain an operating license before installing a medical device. This new procedure is updated to the Medical Devices Regulation 2017/745, and the In Vitro Devices Regulation 2017/746 and applies to:
- Importers (including those of custom made devices);
- Third-party sterilizers;
- Those who assemble CE marking products on kits or procedure packs;
- Medical devices and their accessories;
- In vitro diagnostic devices and their accessories;
- Active implantable medical devices;
- Permanent make-up and tattoo devices;
- Contact lens without a corrective function.
On the other hand, distributors do not need to obtain this license given by the Spanish Health Agency (AEMPS). The application for this license has to be done through the IPS platform, and the AEMPS will inform of the end decision in three months. General requirements to obtain such a license are the following:
- A Quality Management System and an organizational structure in which the responsible technician and the PRRC (from the manufacturer or EAR) are reflected;
- Information on the name and address of the manufacturing site means used to perform the manufacturing activity and procedures and qualifications, if applicable. In cases of suppliers, they would also need to be stated;
- Existence of procedures to train the personnel on medical devices and license-related activities;
- Qualifications (e.g., through CV and working contract) and responsibilities of the responsible technician;
- PRRC details as per article 15 MDR;
- A surveillance contact point;
- Existence of documentation records of the devices (kept for ten years since first placed on the market and fifteen years for active implantable medical devices).
Further details are stated in Annex I of the guidance. Moreover, there are specific requirements for those who assemble CE marking products on a medical device kit or procedure pack, specially on packaging and labelling. The license petition has to be done using the template given in Annex II of the guidance.
A tax also needs to be paid, and the application for the license must be performed a maximum of 10 days after the tax payment.
The license is valid for a limited term (generally five years), which will be stated in the license document. There is a possibility to revalidate the license, with extra documentation required.
This guidance is expected to be updated in the future when the prospective national law on medical devices, active implantable medical devices and in vitro diagnostic medical devices comes into effect.
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Pablo de Mingo Monge
Junior Consultant, Publications Department
AEMPS. (01 April, 2022). Instrucción PS1/2022 sobre el procedimiento de licencia previa de funcionamiento de instalaciones de productos sanitarios. Versión: PS 1/2022. Retrieved on 21/04/2022 from https://www.aemps.gob.es/informa/notasInformativas/productosSanitarios/2022/PS1-Instruccion-2022.pdf?x43061
EUR-Lex. (5 April, 2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 21/04/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424
EUR-Lex. (5 April, 2017). Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Retrieved on 21/04/2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128