According to Regulation (EU) 745/2017, Medical Device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices: devices for the control or support of conception; products specifically intended for the cleaning, disinfection, or sterilisation of other Medical Devices.
Urdí-Solé & Associats, S.L. can offer its services for the following procedures in the field of Medical Devices in different countries:
Activities under Regulation (UE) 745/2017 (MDR)
- Advice as a Person Responsible for Regulatory Compliance (PRRC).
- Account creation and management in EUDAMED database.
- Inclusion of Medical Devices in EUDAMED database.
- Advice on the labelling and marketing of Medical Devices.
- Management and processing of certificates of free sale of Medical Devices.
- Advice and management of the authorisation for advertising of Medical Devices in front of the competent authorities.
- Communication of market placement in the different states of the European Union where this is mandatory or recommended (France, Belgium, Austria, …). Check here the market of your interest.
Procedures and communications in Spain:
- License for manufacturing and import of Medical Devices.
- Communication of the activity of distribution and/or sale of Medical Devices.
- Registration of Class I Medical Devices Person Responsible, custom-made devices and in vitro diagnostic Medical Devices manufactured in Spain.
- Communication of Marketing and commissioning of classes IIa, IIb and III, active implantable and in vitro diagnostic Medical Devices collected in the Annex II of the Royal Decree 1662/2000 and its modifications in the system of “Comunicación de Productos Sanitarios” (CCPS) of the Spanish Medical Agency (AEMPS).
- Inclusion in the financing offer of the Spanish Health National System of Medical Devices.
- Processing of the National Code of Medical Devices to be marketed in the Pharmacy channel in Spain.
Procedures and communications in Portugal:
- Communication of activity of “Distribução por Grosso” in front of the competent Portuguese authority, INFARMED.
- Communication as a manufacturer of Medical Devices to the competent Portuguese authority, INFARMED, in the “Sistema de Informação para Dispositivos Médicos” (SIDM).
- Communication as a distributor of Medical Devices to the competent Portuguese authority, INFARMED, in the “Sistema de Informação para Dispositivos Médicos” (SIDM).
- Processing of the National Code of Medical Devices to be marketed in the Pharmacy channel in Portugal.
Please contact us if you wish to have more information of our services.
Information for the processing of personal data for the purpose of providing professional services
URDI SOLE I ASSOCIATS SL is Responsible for treatment of the personal data of The interested party informs him that this data will be processed in accordance with the provisions of Regulation (EU) 2016/679 of 27 April 2016 (GDPR) and is therefore provided with the following information on the processing:
End of treatment: provision of the professional services requested, including communication with you, and billing, collection and accounting of our fees.
Legitimation of the treatment: for the provision of the entrusted service, the contractual relationship established with you (art. 6.1.b GDPR); for the invoicing, collection and accounting of our fees, the fulfillment of our legal obligations (art. 6.1.c GDPR).
Data retention criteria: they will be kept for no longer than is necessary to maintain the purpose of the treatment; when they are no longer necessary for this purpose and the applicable legal time limits have expired, they will be deleted by the appropriate security measures to ensure that the data is anonymised or completely destroyed.
Communication of data: in addition to the necessary assignments by legal obligation, it is planned to transfer your data to the entities related to the provision of the services in charge that are needed, whenever necessary to achieve the purpose of the processing (public administration, notaries, public records, etc.).
Rights of the interested party:
– Right of access, rectification, portability and deletion of your data and limitation or opposition to its processing.
– Right to file a complaint with the Control Authority (aepd.es) if it considers that the treatment does not comply with current regulations.
Contact details to exercise your rights:
URDI SOLE I ASSOCIATS SL. Tr de dalt, 134 – 08024 Barcelona