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On March 21, the RD 192/2023 on healthcare products was published. This Royal Decree has brought a series of substantial changes especially for manufacturers and importers of healthcare products, products from Annex XVI, instruments for tattoos and semi-permanent and permanent makeup, and reprocessors of single-use products.
This time we will focus on a modification that we consider of great importance: online and mail-order distribution and sales.
Who and what products does the RD apply to?
First of all, it should be clarified that this Royal Decree applies to the following economic agents located in Spain:
Manufacturers Importers Distributors Aggregators Sterilizers
And it applies to the following products or types of products:
Healthcare products. Accessories for healthcare products. Non-medical purpose products from Annex XVI of the MDR. Devices and instruments used in permanent, semi-permanent makeup or tattooing by invasive techniques (note these do not have CE marking).
Therefore, if you are a manufacturer of devices used in tattooing, or eyeglass frames (accessories for healthcare products) or hair removal lasers, liposuction devices, etc. (Annex XVI of the MDR) this Royal Decree applies to you. Or if you are importers or distributors or aggregators or sterilizers of any of them.
Distribution and sale
One of the most discussed aspects in the months leading up to the implementation of this law was how the sale of these products on online platforms like Amazon, Shein, Ali Baba, etc., or on the manufacturers’ own websites would be regulated.
The RD has clarified this by determining which products CANNOT be sold online or by mail order:
sale to the public is prohibited by mail order and by telematic procedures of healthcare products subject to prescription, that is:
Custom-made products, those manufactured by order of a healthcare professional who can prescribe for a single person. Products manufactured in series through industrial manufacturing processes according to the written prescriptions of any authorized person. Basically, those prescribed by a physician. Those funded by the national health system: The list is long, but basically among the national codes 400011 and 499996. Products like urinary catheters, colostomy bags, knee braces, elbow braces, various adhesive dressings, cotton of different types, etc., etc., etc. Those intended to be used or applied exclusively by healthcare professionals. Non-medical purpose products from Annex XVI of the Regulation (EU) 745/2017 or MDR. For example, colored contact lenses, hair removal lasers, liposuction devices, etc.
Therefore, manufacturers, importers, or distributors of these products cannot sell them online or by mail order to the general public.
This means that:
The sale of these products to the public through any online platform or company websites is prohibited. It is necessary for the public to go to an authorized physical store to purchase these products. Distribution and sale activities
Furthermore, the RD indicates that the distribution and sale of the mentioned products will be monitored by the health authorities of the Autonomous Community where the distributor or point of sale is located.
Both distributors and companies or individuals engaged in the sale of these products must make a prior communication of the start of activity to the health authority of the Autonomous Community where they are located and, if they have a warehouse in another autonomous community, also to the health authority of the other autonomous community.
The prior communication of the start of activity will contain:
Identification of the distribution or sales establishment, when applicable. Types of products distributed or sold. Identification and qualification of the technical manager. Exclusive public sales points do not need to have the figure of a technical manager.
Pharmacies do not have to make the prior communication unless they sell products that require individualized adaptation.
deviCE Sistemas as a consultancy specialized in healthcare products, performs all the procedures related to the sale and distribution of healthcare products, such as prior communication of the start of activity, technical manager, etc.