In brief

The Spanish Ministry of Health is working on a project for a new royal decree regulating medical devices following the adoption of a new framework at the European level through Regulation (EU) 2017/45 of the European Parliament and the Council of 5 April 2017 on medical devices. 

The scope of the project extends to all products mentioned in Article 1 of Regulation (EU) 2017/45, which includes medical devices for human use and their accessories, certain non-medical devices listed in Annex XVI of Regulation (EU) 2017/45 and clinical investigations concerning the aforementioned medical devices. The project also applies to medical devices that incorporate products for in vitro diagnostics subject to EU commerce and exports. 

The importance of the project lies in the new features it will introduce, which include the establishment of requirements and procedures for the regulation of products manufactured and used in healthcare facilities (in-house products), the regulation of the reprocessing procedure of single-use medical devices, the establishment of the national commercialization registry and an update to the regulation of implant cards.

A closer look 

The new royal decree project, currently in the hearing and public information phase until the 10 July, will introduce a set of rules regulating medical devices in accordance with the dispositions of Regulation (EU) 2017/45 of the European Parliament and the Council of 5 April 2017 on medical devices.

The European regulation harmonizes the rules applicable to placing on the market and putting into service medical devices and their accessories, allowing them to benefit from the principle of free movement of goods while guaranteeing a high level of protection. On the other hand, the regulation consolidates the normative criteria applicable to a series of relevant matters, such as the supervision of notified bodies, clinical conformity assessment procedures, clinical investigations and clinical evaluation, market surveillance and control. It also establishes the obligations of member states with respect to the qualification of products regarding border cases.

The main changes introduced by Royal Decree 370/2021 are the following:

1. Competent authority. In accordance with Article 101 of Regulation (EU) 2017/745 the Spanish competent authority in charge of the application of such regulation is the Agencia Española de Medicamentos y Productos Sanitarios. 
2. Prior operating license. The prior operating license requirement is extended to non-medical products listed in Annex XVI and to healthcare facilities engaged in the activity referred to in Articles 5.5 (products manufactured and used exclusively in healthcare facilities) and 17 of the regulation (reprocessing and reuse of single-use products).
3. Manufacture of products by healthcare facilities for their own exclusive use. Products manufactured and used exclusively in healthcare facilities can only be produced in hospitals, which may not subcontract any of their manufacturing activities and must have a prior operating license. Moreover, there is a ban on the sale to the public or delivery to third parties of products manufactured in hospitals.
4. Reprocessing of single-use medical devices. Reprocessing and reusing single-use products, regulated in Article 17 of the regulation, can be done by physical or legal persons, as well as by hospitals. Manufacturers of reprocessed products may only distribute the products directly to hospitals, as they are prohibited from sale to the public. Hospitals must inform patients of the use of reprocessed products in their hospitals and can use them exclusively on one patient and during one specific procedure. 
5. Commercialization registry. This project provides for the creation of a commercialization registry under the Spanish Agency of Medicines and Medical Devices (AEMPS) for products distributed in Spain, in order to establish their traceability. It also regulates distribution and sales activities, including the display of products for these commercial purposes.
6. Clinical investigations. This refers to Royal Decree 1090/2015 of 4 December, regulating clinical trials with medicinal products, the Ethics Committees for Research with medicinal products and the Spanish Registry of Clinical Studies.
7. Market control activities. The AEMPS will coordinate market control activities in collaboration with the health authorities of the autonomous communities in order to comply with the provisions of Article 93 of Regulation (EU) 2017/745 and will adopt the appropriate measures to promote cooperation and mutual assistance with the health authorities of the autonomous communities.
8. EUDAMED. Pursuant to Article 123.3.d of Regulation (EU) 2017/745, until Eudamed is fully operational, the corresponding provisions of Royal Decree 1591/2009 of 16 October 2009 and Royal Decree 1616/2009 of 16 October 2009 will continue to apply for the purpose of fulfilling the obligations of information regarding the communication of commercialization and putting into service, registration of market launchers, clinical investigations, certificate notifications and surveillance notifications, among others.