The new Spanish Medical Devices Regulation (Spanish MDR) aims to bring domestic regulations on medical devices in line with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (EU MDR) and to develop those aspects that the EU MDR leaves to regulation at the national level, including rules on permitting, medical devices manufactured and used in a health center (known as ‘in house’), reprocessing of single-use medical devices, national marketing registry, medical devices subject to prescription, language regime, clinical investigations, market surveillance and control or foreign trade.
Going into more detail of the Spanish MDR:
- It includes general provisions on its purpose, definitions (it refers to the EU MDR and the acts issued for its implementation), scope of application (medical devices of Article 1 EU MDR and devices and instruments used in permanent or semi-permanent makeup or skin tattooing by invasive techniques), competent authority (Spanish Agency of Medicines and Medical Devices, AEMPS), health guarantees, administrative cooperation between the AEMPS and the autonomous regions (particularly in relation to registrations, market control and surveillance) and language regime.
- With regard to manufacturing, grouping, sterilization and import activities, it specifies the requirements that companies engaged in these activities must meet, as well as the procedure to be followed for the granting of the prior operating license. In terms of major developments:
- for the first time, a distinction is made between a legal importer and a physical importer, both of which are subject to prior operating license;
- specific rules are introduced on the manufacture of medical devices by hospitals for their exclusive use in the hospital itself (i.e., not intended for subsequent marketing or economic profit and designed for specific groups of patients for whom there are no alternatives on the market); and
- specific aspects are detailed on the activities of manufacturers of custom-made medical devices, which must be registered with the registry of those responsible for placing custom-made devices on the market.
- As regards the reprocessing of single-use medical devices, specific rules are introduced on (i) the parties authorized to carry out these reprocessing activities (manufacturers, hospitals and external reprocessors) and (ii) the conditions for the use of reprocessed products.
- It addresses the regime of Notified Bodies and, more precisely, the authority and conditions for their designation, the verification of their suitability, procedure and documentation requirements, the revocation of the designation and the obligations of the designated bodies.
- With respect to the rules on marketing and putting into service:
- it provides for the creation of a marketing registry for products distributed in Spain (which replaces the current system of Registration of Persons Responsible for Medical Devices and Communication of Marketing of Medical Devices), so that any economic operator that markets products in Spain must (i) make the relevant communication to the marketing registry and (ii) keep a documented record of the marketed products;
- it defines in more detail, beyond what is provided for in the EU MDR, the obligations of the economic operators involved in these activities, including manufacturers, authorized representatives, importers and distributors;
- it provides for comprehensive regulation of distribution and sales activities, establishing for the first time in Spanish legislation the concept of medical devices subject to prescription (at least for the purposes of the Spanish MDR, which affects, among other areas, the distance sale of this type of products – under Spanish law, the distance sale of medical devices subject to prescription is prohibited) and expressly including the prohibition of the sale to the public of medical devices intended to be used or applied exclusively by health care professionals; and
- it settles the debate on the distance sale of individually adapted medical devices that are capable of successive deliveries (e.g.. contact lenses), expressly allowing such sale provided that it is verified that it matches the initially adapted product and that advice upon request by the buyer/user is provided.
- In the area of clinical investigations, specific rules on clinical investigations carried out to demonstrate the conformity of the products are introduced, among which the following stand out:
- products can only be made available to physicians if the investigation has the favorable opinion of the Ethics Committee;
- labels and instructions for use must be written at least in Spanish; and
- details about the linguistic regime of the authorization procedure, so that the application, the investigator’s manual, the clinical investigation plan, the informed consent and the label and instructions for use of the investigational product, must be submitted at least in Spanish; and all this complemented by the instructions on clinical investigations recently published by the AEMPS.
In addition, it regulates (i) compensation for damages, (ii) liability regime and (iii) clinical investigations with CE marked products and other clinical investigations.
- Last but not least, the Spanish MDR also addresses issues related to foreign trade, specifying the requirements to be applied by the health inspection at import, the surveillance system and market control activities and health protection measures, with special emphasis on inspection activities.
Next steps
We routinely advise clients on complex challenges in the medical device industry. For more details on the new Spanish MDR and how it impacts the medical device industry, please contact the author or the Hogan Lovells attorneys with whom you regularly work.
Authored by Álvaro Abad.
