In brief
The PMPS, in which commercial communications of medical devices were registered, ceased to be operational and was replaced by the new CCPS application of the AEMPS. However, communications made to the PMPS were still valid, although they cannot be managed until they are migrated to the CCPS. Consequently, the AEMPS has set the deadline of 18 July 2023 for the transfer of marketing communications to the new CCPS application, requesting companies to retrieve them by that date, updating their information and submitting them to the necessary review by the AEMPS, prior to their inclusion in CCPS.
In more detail
Until 4 July 2018, the registration of commercialization communications of medical devices provided for by Article 18 of Royal Decree 192/2023, on medical devices (hereinafter, “RDRPS“), and Article 10 of Royal Decree 1662/2000 (hereinafter, “RDPSDIV“), on medical devices for “in vitro” diagnosis, was carried out through the Commissioning of Medical Devices application (hereinafter, “PMPS“). As of the aforementioned date, the application ceased to be operative, and the Communication of Medical Devices Commercialization application (hereinafter, “CCPS“) of the Spanish Agency of Medicines and Medical Devices (hereinafter “AEMPS“) began to operate, with the intention of replacing the previous one.
Through this electronic portal, it is possible to register the commercialization communications in Spain of class lIa, Ilb and III medical devices provided for in Regulation (EU) 2017/745 (hereinafter, “Regulation“); active implantable medical devices that may be covered by Article 120 of the aforementioned Regulation; as well as class B, C and D in vitro diagnostic medical devices provided for in the Regulation; in vitro diagnostic medical devices from lists A and B and those for self-testing regulated by Article 110 of the latter Regulation. In terms of national legislations, the regulations that provide for the commercialization communication referred to above are the RDRPS, Royal Decree 1616/2009, on active implantable medical devices, and RDPSDIV.
It should be noted that users who already have credentials for the PMPS application do not need to apply for new ones to use the newly developed application, although they should recover the communications registered in PMPS to enter them in CCPS, for which the AEMPS provides companies with a Guidance Manual, which is available on its web page. As reported by the AEMPS, the communications registered in PMPS could only be managed once they had been transferred to CCPS, although they remained legally valid until the transfer was completed.
However, what currently matters is that the AEMPS has set 4 July 2023 as the deadline by which PMPS communications can be retrieved, which is why it asks companies to recover their pending communications before that date, after which no communications should remain unretrieved in the obsolete PMPS application. The purpose of the established deadline is to keep medical device commercialization communications up to date, and its raison d’être lies in the CE certificates’ maximum validity period of five years. Therefore, companies must recover communications registered in PMPS by 4 July 2023, since otherwise they will lose that information and the prior communication will not be valid until a new one is made through the renewed CCPS. To this end, once the user has retrieved the registered information, which must be completed or updated, it will be sent to the AEMPS for review.
Gathering the currently valid communications in a single application will allow to recover their management, correct deficiencies, modify outdated data, delete communications if necessary from the databases, among others; in addition to the benefits already inherent to the application itself, among which are the submission of commercialization data, documentation and clarifications, apart from being able to consult them at any time.
Finally, it is important to emphasize the responsibility of the legal entity with regard to the access credentials of the application, having to change the password in the event that certain persons or employees cease to have the appropriate legitimate power of access.
In short, this new development is particularly relevant for all those companies involved in the marketing of medical devices and who do not want to get lost in the procedures to be carried out before the AEMPS. In this regard, Baker McKenzie has a team of experts who will be able to assist you with all the procedures related to this innovation.
