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MDR and IVDR Requirements for Products Manufactured in house It is common practice for healthcare centers in general and hospitals in particular to manufacture medical products, as clinicians often face difficulties in finding medical products that meet specific needs for a patient or patients, for a particular ailment or treatment. This practice is colloquially known as products in house and refers to medical products manufactured in healthcare centers and made available to patients. Until the application of the Regulations, the MDR and the IVDR, there were no specific legal requirements for this type of medical products, nor for the healthcare centers that manufactured them in relation to their commissioning. However, both the MDR and the IVDR have an entire article that determines the requirements to be met by healthcare centers for the manufacture of medical products. It is established in the regulations that a medical product can only be placed on the market or put into service, that is, it can only be made available to the end user when the provisions of Regulations (EU) 745/2017 or (EU) 746/2017 are met. Additionally, they must be properly supplied, installed (if applicable), maintained, and used correctly according to their intended use. But in the case of products manufactured by healthcare centers, things change. Certainly, as manufacturers of medical products, they must ensure that their products meet the general safety and performance requirements, but these are the only requirements of the Regulation they must initially comply with.
Healthcare Centers Manufacturing Their Own Products. Healthcare centers as manufacturers can only manufacture medical products if: f there are no equivalent products on the market f they are manufactured within an appropriate quality management system f they are not transferred to other legal entities (to other entities with a different CIF)
And these products manufactured in house must have documentation that sufficiently details: f the installation of the product, f the production process, f the design and f the performance data of the same However, the Regulations leave it to each state to allow healthcare centers to provide additional information to their competent authority about the medical products manufactured and used in their territory.
New Requirements from the Spanish Medicines Agency for “In House” Products. The Spanish Medicines and Medical Devices Agency (AEMPS) has taken up the challenge and developed specific requirements for these manufacturers in its new Royal Decree. Requirements for Medical Products Manufactured in house in Spain. The Spanish Medicines and Medical Devices Agency (AEMPS) has established a series of requirements regarding medical products in the new Royal Decree about to be published. In Article 9 of this upcoming Royal Decree, it is clearly indicated what requirements the AEMPS as the competent authority will demand from healthcare centers. The first indication is that only Hospitals will be able to carry out the manufacturing activities of Medical Products in house with the aforementioned considerations of the reference Regulations. That is, any healthcare center located in Spain that is not a hospital will not fall under the characteristics of in house manufacturing nor its specific considerations. Additionally, hospitals that manufacture in house must obtain from AEMPS the Prior Operating License for Facilities, which is unofficially called the Health License. Hospitals that manufacture cannot subcontract any of the manufacturing activities and cannot manufacture class IIb, class III, or implantable products. Products manufactured in hospitals cannot be sold publicly, nor transferred or made available to others. This means that a hospital with a specific CIF cannot transfer, sell, gift, or deliver a product manufactured on its premises to another hospital with a different CIF or another company. Additionally, hospitals can only reprocess products that have been used and reprocessed in their hospital or by an external reprocessor included in their license. Hospitals cannot sell or deliver the reprocessed product to third parties.
Modifications in Requirements for the Prior Operating License of AEMPS Facilities Next, it mentions that hospitals that carry out the manufacturing of medical products in house must have a Prior Operating License for Facilities. Until the application of the new RD, the prior facilities license was required for: f Serial manufacturers of medical products medical products, non-corrective contact lenses products for tattooing, micropigmentation, and permanent makeup f Importers of medical products non-corrective contact lenses products for tattooing, micropigmentation, and permanent makeup f Sterilizers of medical products, non-corrective contact lenses products for tattooing, micropigmentation, and permanent makeup f Assemblers of medical products, non-corrective contact lenses products for tattooing, micropigmentation, and permanent makeup However, from the application of the new Royal Decree, those who must have a Prior Operating License for Facilities will be (if no changes occur in the publication): f Self-employed or companies engaged in the manufacturing, importing, assembling, or sterilizing of medical products f Self-employed or companies engaged in the manufacturing, importing, assembling, or sterilizing of products without medical purpose (those in Annex XVI of the MDR) f The Hospitals that manufacture medical products in house f The importers of products, that, not being importers by definition of the Regulations, carry out the physical importation of products into Spain f Companies that carry out the complete manufacturing of products for third parties, that is, not being the legal manufacturers, they are the manufacturers of the entire product f Companies reprocessors of single-use products and hospitals that reprocess single-use products that they have not manufactured themselves Special attention should be paid to the new cases introduced by the Royal Decree: The importers, who are not importers according to the definition of the Regulations. An importer of medical products is a company or self-employed person located in the EU who brings medical products from a third country, that is, from a country outside the European Union, into the European Union. Therefore, the company manufacturing a medical product (and as determined on the labeling, instructions, and CE Declaration of Conformity of the product) that manufactures or produces its product in a country outside the EU is not an importer. On the label of this product, there will not be an Authorized Representative, nor will there be a document with the product that includes the importer, since the manufacturer is from the European Union. These companies are legal manufacturers of the products and not importers and should have had a prior operating license as a manufacturer. However, considering this new requirement of the Royal Decree and if it is not modified before its publication, these legal manufacturers would also have to obtain the operating license as importers of medical products. Another interpretation of this new requirement is that, with the product already imported and available in the EU, a company or self-employed person located in Spain carries out the physical importation of the productfrom another EU country to Spain. Obviously, in this case, it is not an importer, since the product is already in the EU, but it brings it to Spain. In this case, they would also need to have a Prior Facilities License as an importer. Companies that carry out the complete manufacturing for third parties. In addition to hospitals that manufacture medical products and non-importer importers, companies that carry out the complete manufacturing of products for third parties also need to obtain the prior operating license for companies that carry out the complete manufacturing for third parties. This is the case for many subcontracting companies that carry out the complete manufacturing, but in the labeling and all product documentation, the manufacturer is the client company. If the subcontractor that carries out the complete manufacturing is located in Spain, it must obtain the manufacturer’s operating license. The Royal Decree mentions the complete manufacturing of products for third parties, which can be understood to mean that the subcontractor manufactures the complete product. Companies reprocessors of single-use products. Companies or self-employed persons that reprocess single-use products to make them fit for use again must obtain the Prior Operating License for Facilities as manufacturers. However, as an exception, reprocessors of single-use medical products at the request of a hospital do not need to obtain the license. The information mentioned here refers to the Spanish Royal Decree draft not yet published by AEMPS. If, when the official publication of the Royal Decree is made, there are any changes to what has been interpreted, a new article with the appropriate corrections will be made.