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On December 7, 2022, we published on our website www.devicesistemas.com news regarding the anticipated updates in the draft of the new Royal Decree regulating medical devices, which was being developed. In that news, we promised to keep informing when we had more data. Yesterday, on March 21, 2023, the final Royal Decree 192/2023 regulating medical devices was published.
As we indicated in the mentioned news, and with the new RD 192/2023 in hand, we consider that the most important updates of Royal Decree 192/2023 are:
The prior operating license for facilities—who must obtain it? Considerations for hospitals manufacturing medical devices. The so-called “in house” products. Marketing registration.
Let’s go through them one by one.
PRIOR OPERATING LICENSE FOR FACILITIES WHO MUST OBTAIN IT?
The new Royal Decree maintains the requirement for obtaining this License for the natural and legal persons established by the old one, but adds some more. Specifically, it specifies that any natural and legal person engaged in the manufacturing, importing, grouping, or sterilizing of:
Medical devices, Apparatus and instruments used in permanent, semi-permanent makeup, or skin tattooing through invasive techniques. Products without medical purpose. That is, products whose purpose is mainly aesthetic and are regulated by Annex XVI of the MDR or Regulation (EU) 745/2017 on medical devices. Those who carry out the complete manufacturing of products for third parties. This means companies that, not being the “legal” manufacturers (responsible for the CE marking of the product), manufacture, produce, the entire product for another company, usually the “legal” manufacturer of the product. Import of semi-finished products. Those who reprocess single-use products to make them suitable for new use within the EU. Hospitals that carry out reprocessing activities of single-use medical devices. (change from the draft).
It is surprising that the requirement to obtain the license for Manufacturers, Importers, Groupers, or Sterilizers of apparatus and instruments used in permanent, semi-permanent makeup, or tattooing through invasive techniques is maintained. This type of product has been specifically excluded from the groups of products with an aesthetic purpose of Annex XVI of the MDR.
Reviewing the common specifications of the products in Annex XVI, in the Implementing Regulation (EU) 2022/2346, in Annex III it mentions: “However, products for tattoos, piercings and products intended to be wholly or partially introduced into the human body by invasive surgical means for the purpose of body part fixation are NOT included in the scope of application”. In Annex IV regarding substances, combinations of substances, or articles intended for use as facial fillers (…), excluding those intended for tattooing”.
Certainly, these instruments or devices for tattoos or permanent makeup cannot have a CE marking as medical devices since the MDR does not apply to them, but their manufacturers or importers must obtain a prior facilities license.
IMPORTERS AND THE PRIOR OPERATING LICENSE
Another interesting novelty of this Royal Decree relates to importers. The concept of Importer refers to the natural or legal person who introduces a product, medical in this case, from a country manufactured outside the EU.
Until now, if a Spanish Manufacturer had a subcontract outside the EU to manufacture the product, they only needed to obtain the manufacturer’s license, logically. However, from now on, those who, being Spanish manufacturers, manufacture their product outside the EU and physically import it must also obtain the import license.
Another new situation concerns Semi-finished Products. From now on, in the case of imports of semi-finished products (i.e., entering the EU from third countries), customs will check that the importer has the manufacturer’s license (because it is a product that will form part of theirs for which they have a license) or the importer’s license.
MANUFACTURERS OF PRODUCTS FOR THIRD PARTIES
From now on, manufacturers of complete products for third parties must obtain the Prior Operating License as manufacturers. An activity that many companies actually perform. The good news is that companies currently performing this activity have 1 year to apply for it (March 21, 2024).
Not so for those companies that may now be negotiating to be the manufacturers of a medical device (or others referred to by the license) for other companies. They will have to add obtaining the license to their roadmap.
REPROCESSORS OF SINGLE-USE PRODUCTS
Natural or legal persons who reprocess single-use products to make them suitable for new use within the EU are considered manufacturers of the reprocessed product and, therefore, must comply with the obligations of manufacturers established in Article 10 of the MDR, including the requirements of this Royal Decree, among others, obtaining the operating license.
Hospitals that reprocess single-use products must also obtain the operating license.
“IN HOUSE” PRODUCTS. HOSPITALS THAT MANUFACTURE MEDICAL DEVICES
Unlike what was stated in the draft of this Royal Decree, hospitals that manufacture medical devices will not need to obtain the operating license. They will only need to make a prior communication of activity start to the AEMPS.
MARKETING REGISTRATION Any economic agent, that is, manufacturers, importers, distributors, or authorized representatives marketing products in Spanish territory, that are not custom-made, must be included in the AEMPS marketing registration.
In this registry, companies and the products they market will be identified. Annually, the communication must be updated indicating the products that continue to be marketed. This update is very important because not doing so will result in the products and the economic agent being removed from the registry.
NOTE: When referring to products, it refers to medical devices, products without medical purpose of Annex XVI of the MDR, accessories of medical devices, and instruments for tattoos.