Licenses and authorizations for the manufacture, distribution and commersialitation of medical devices.
According to Regulation EU 745/2017, a medical device is 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 devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Urdí-Solé & Associats, S.L. can offer its services for the following procedures in the field of medical devices in different countries:
• License for the manufacture and import of medical devices.
• Communication of the activity of distribution and/or sale of medical devices.
• Advice on labelling and placing on the market of medical devices.
• Register of Responsible Person for Class I Medical Devices, custom and in vitro diagnostic products manufactured in Spain.
• Communication of Marketing and commissioning of medical devices classes IIa, IIb, III, active implantable medical devices and medical devices for in vitro diagnosis included in Annex II of Royal Decree 1662/2000 and modifications in the Communication platform of CCPS Health Products of the Spanish Medical Agency (AEMPS).
• The inclusion of medical devices in the financing offer of the Spanish National Health System.
• Processing of the National Code for medical devices to be marketed in the Pharmacy channel in Spain.
• Advice and management of the authorization of the advertising of medical devices in front of the competent authorities.
• Management and processing of certificates of free sale of medical devices.
• Communication of the activity of Distribução por Grosso in front of the competent Portuguese authority, INFARMED.
• Communication as a manufacturer of medical devices in front of the competent Portuguese authority, INFARMED, through the System of Information for Medical Devices (SIDM) platform.
• Communication as a distributor of medical devices in front of the competent Portuguese authority, INFARMED, in the System of Information for Medical Devices (SIDM).
• Processing of the National Code of medical devices to be marketed in the Pharmacy channel in Portugal.
• Communication of the placing on the market in the different states of the European Union where it is mandatory or recommended (France, Belgium, Austria, ...). Consult the country you are interested in.
Activities under Regulation (EU) 2017/745 (MDR)
• Advice as a Person Responsible for Compliance with Regulations (PRRC).
• Creation and management of the account in the EUDAMED database.
• Inclusion of medical devices in the EUDAMED database.