The Council of Ministers approves the Real Decreto (Royal Decree) regulating medical devices to guarantee the highest level of safety and protection of patients’ health- This rule will apply to medical devices for human use and their accessories, and to the apparatus and instruments used in permanent or semi-permanent make-up or in skin tattooing by means of invasive techniques.- The sale to the public by mail order and by electronic means of medical devices subject to prescription is prohibited, as well as of implantable medical devices or of any other device intended to be used exclusively by healthcare professionals, together with their street vending.
Madrid, 20 March 2023.- The Council of Ministers today approved, at the request of the Minister of Health Carolina Darias, the Royal Decree regulating medical devices. The purpose of this rule is to establish a new, more robust, transparent, predictable and sustainable regulatory framework for medical devices, guaranteeing the highest level of safety and protection of the health of patients and users.
This royal decree, which replaces those in force since 2019, adapts national legislation on medical devices in line with the provisions of the European Union Regulation, which has been applied since 2021.
This regulation has harmonised the rules applicable to the placing on the market and putting into service in the EU of medical devices and their accessories, thus allowing them to benefit from the principle of free movement of goods, and also guaranteeing a high level of protection, so that the devices in circulation do not present risks to the health of patients, users or third parties and achieve the performance assigned by the manufacturer when used under the intended conditions.
This rule will apply to medical devices for human use and their accessories, and to the apparatus and instruments used in permanent or semi-permanent make-up or in skin tattooing by means of invasive techniques.
The competent authority in this matter will be the Spanish Agency of Medicines and Medical Devices (AEMPS), which may consult the Medical Devices Committee.
Medical devices may only be placed on the market, made available and put into service when they have been duly supplied, are correctly installed and maintained in accordance with the manufacturer’s instructions and are used in accordance with their intended purpose, without compromising the safety or health of patients, users or third parties.
The royal decree provides for the necessary cooperation between the AEMPS and the autonomous communities and cities in matters of registers, market control and vigilance.
Facilities
It establishes that natural and legal persons engaged in the manufacture, import, assembly into systems or procedure packs, or sterilisation of medical devices, and the facilities in which they carry out these activities, will require a prior operating licence granted by the AEMPS.
The specific aspects of the activities of manufacturers of custom-made devices are detailed; these manufacturers must be entered in the Register of persons responsible for placing custom-made devices on the market.
With regard to the manufacture by hospitals of devices for their own exclusive use, the decree lays down the obligation to notify the start of the activity and to declare to the AEMPS that the devices comply with the general safety and performance requirements.
Measures are also established concerning the reprocessing and re-use of single-use devices, and the regime for notified bodies is regulated.
Marketing of devices
The royal decree provides for the creation of a marketing register for the devices distributed in Spain.
It determines that only devices that comply with the provisions of both the EU Regulation and the royal decree, and that are not expired, may be distributed and sold.
Distribution and sales activities will be subject to the vigilance and inspection of the corresponding regional health authorities.
The sale to the public by mail order and by electronic means of medical devices subject to prescription is prohibited, as well as of implantable medical devices and of any other device intended to be used exclusively by healthcare professionals.
The street vending of medical devices is also expressly prohibited.
However, sale through vending machines will be permitted, provided that the integrity and safety of the device are not impaired, except in the case of devices subject to prescription.
The presentation at trade fairs, exhibitions and demonstrations of devices that do not comply with the provisions of this royal decree is permitted, provided that a sufficiently visible sign clearly indicates that such devices cannot be placed on the market or put into service until they have been brought into conformity.
Clinical investigations
Furthermore, the decree regulates the aspects relating to clinical investigations to demonstrate the conformity of devices.
Accordingly, devices may only be made available to practitioners if the investigation has received a favourable opinion from the Research Ethics Committee for medicinal products (CEIm).
Vigilance
It also establishes that healthcare professionals and authorities who become aware of a serious incident must report it to the AEMPS, which will forward it to the manufacturer of the device concerned. Patients and users may also do so, without prejudice to having reported it to the manufacturer or to the healthcare professional.
In addition, it provides that the AEMPS, in order to guarantee the protection of people’s health, safety or compliance with public health rules, may adopt all necessary and justified measures with respect to a device, category or specific group of devices, which includes issuing provisions on their conditions of use or on special monitoring measures, and requiring the inclusion of the necessary warnings to avoid health risks in their use.