The Royal Decree 1591/2009 It is a legal text, published in the Official State Gazette (BOE) by the Spanish Government, which applies to all the autonomous communities within Spain and regulates medical devices.
In Article 24, Royal Decree 1591/2009 introduces the concept of the Register of Responsible Persons for the Placing on the Market of Medical Devices. In other words, it stipulates that there will be a register in which those responsible for placing a medical device on the market must register and notify the authorities of their products.
How does the registration process work? What should I do if I want to register as the person responsible for placing my medical devices on the market? Read on if you want to find out the answers to these and other questions relating to registration!
Register of Persons Responsible for Placing Medical Devices on the Market: What exactly does Article 24 of Royal Decree 1591/2009 state?
Article 24 of the Royal Decree 1591/2009, regulating medical devices In Spain, the text reads as follows:
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Any manufacturer established in Spain that places Class I products, as well as custom-made products, on the market, will carry out a notification to the Spanish Agency for Medicines and Healthcare Products so that it can be included in the Register of Persons Responsible for Placing Products on the Market which remains the same, and will contain the the address of its registered office and the description of the products in question. This obligation shall also apply to the authorised representative where they are established in Spain.
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Any changes to the details set out in the previous section will be communicated in accordance with the procedure set out in this article. Also notification of termination will be given the placing of products on the market.
In summary, The wording of this legal text presents us with the following situation:
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- Manufacturers of Class I or custom-made medical devices, must register with the Register of Responsible Persons for the Placing on the Market of Medical Devices.
- The Data Controller shall be the legal entity responsible for to notify the placing on the market of products, as well as any amendment or the termination itself.
Would you like to find out more about the Royal Decree regulating medical devices?
GTF brings you the latest news about the Register
From the Gabinete Técnico Farmacéutico M. Camps, we would like to inform you of the new app which has been drawn up by the AEMPS (Spanish Agency for Medicines and Healthcare Products) for manufacturers of medical devices established in Spain who wish to place their products on the market Class I medical devices y Bespoke Healthcare Products (including active implantable medical devices).
This application complies with the provisions of Article 24 of the Royal Decree 1591/2009 of 16 October, regulating medical devices. The new RPS s applicationIt replaces the old one, which will remain operational solely as a reference database until its permanent closure scheduled for 2023.
All users of the Register of Data Controllers They must register on the new app, even if they have already signed up. This will allow them to retrieve the messages sent on the former RPS whilst updating them at the same time in the new app. This communication is carried out online. Once the procedure is complete, the AEMPS sends a new document containing the registration number relevant.