New Royal Decree on Medical Devices – On 20 March, the Council of Ministers Spain approved the Royal Decree 192/2023 of 21 March, regulating medical devices.
This new Spanish legislation will enable Spain to bring its regulations on medical devices into line with the Regulation (EU) 2017/745 on medical devices of the European Commission. Furthermore, this Royal Decree sets out the provisions of national legislation relating to those aspects which the Regulation leaves to the Member States to regulate.
Would you like to know how the publication of the new Royal Decree on Medical Devices affects you? And find out what regulations have been introduced at national level? Read on!
Royal Decree on Medical Devices: an introduction to the new national regulations on medical devices
On 20 March, the Spanish Government, through the Council of Ministers, finally approved the new national regulations on medical devices. The Royal Decree 192/2023 of 21 March, regulating medical devices, was published on 22 March in the Official State Gazette (B.O.E.).
This new piece of legislation, which is inevitably modelled on the Regulation (EU) 2017/745 on medical devices - the European text will remain in force, alongside the new Royal Decree – and will allow the previous national legislation to be repealed; this consisted of two Royal Decrees published in the Official State Gazette (B.O.E.) in 2009 and which had been in force since 2010:
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- Royal Decree 1591/2009, of 16 October, regulating medical devices (in force since 2010)
- Royal Decree 1616/2009, of 26 October, regulating active implantable medical devices.
Thanks to the new Royal Decree 192/2023, national legislation on medical devices will henceforth comply with the Regulation 2017/745, the common rules for the eurozone which all member states must comply with – with the exception of a few specific points where national authorities are given discretion, and which you can read more about below.
In short, with the adoption of this new Royal Decree on Medical Devices, As published in the Official State Gazette (B.O.E.) on 22 March, the Spanish government has updated national legislation to ensure that it, in turn, complies with the standards required by the European Commission through the Regulation 2017/745.
As countries adapt their own legislation on medical devices to the common European framework, the result is similar to that achieved by the legislation on cosmetics: to create a common market, in which all products comply with a shared regulatory framework, not at national level, but across the EU as a whole. And therefore, to establish shared standards which enable the following objectives to be met:
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- To ensure the safety, quality and good manufacturing practices of all medical devices manufactured and placed on the market within the EU
- To promote and facilitate the free movement of these products between member countries.
What are the key changes introduced by the new Royal Decree on Medical Devices in relation to European Regulation 2017/745?
Recently, the Spanish Agency for Medicines and Health Products (AEMPS) has published an information note setting out the points that have been addressed at national level following the publication of the Royal Decree 192/2023 of 21 March, regulating medical devices.
According to the AEMPS, the new Royal Decree on Medical Devices It is in line with European regulations regarding health protection, transparency and the promotion of innovation. However, the publication of the new Royal Decree also introduces some significant changes.
The fact is, there are certain issues regarding the Medical Devices Regulation 2017/745 which, provided they do not conflict with any aspect of European legislation – which is also currently in force – would be left to the discretion of the national authorities of EU Member States, including, in particular, manufacture in healthcare facilities or reprocessing.
Furthermore, the AEMPS information note provides a list of these new features included in the Royal Decree 192/2023, on which legislation has been enacted that affects us at national level:
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- the designation of the competent authority for the purposes of Regulation (EU) 2017/745 and the establishment of the language regime.
- the manufacture of products for use within the healthcare facility itself (commonly referred to as “in-house”).
- the reprocessing and reuse of single-use products.
- the marketing register.
- prescription-only medicines.
- the authorisation of clinical trials.
market surveillance and control obligations.
foreign trade requirements.
Healthcare Products: a diverse and rapidly growing sector within the pharmaceutical and healthcare industry
The Medical Devices Regulation 2017/745 defines them as «any instrument, device, equipment, computer programme, implant, reagent, material or other article intended by the manufacturer to be used on human beings, either on its own or in combination with other items, for any of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or relief of a disease
- diagnosis, monitoring, treatment, relief or compensation for an injury or disability
- investigation, alteration or modification of the anatomy or of a physiological or pathological process or condition
- the collection of information through the in vitro examination of samples taken from the human body, including
organ, blood and tissue donations,
And which does not exert its intended primary action within or on the surface of the human body through mechanisms
pharmacological, immunological or metabolic, but to whose function such mechanisms may contribute.
The following products shall also be regarded as medical devices:
- products designed to aid or support conception
- products specifically intended for the cleaning, disinfection or sterilisation of products that are
as set out in Article 1(4) and in the first subparagraph of this point
If we analyse this definition, we quickly realise that it is a very broad concept. It is a diverse product category, encompassing a large number of items that are very different from one another. A vast range of product types that are used on a daily basis in the fields of health and beauty. With the development of the sector healthtech and the health technologies, the range of medical devices is growing day by day, and this trend does not look set to reverse.
In fact, the Definition of Medical Devices is currently undergoing significant change. In traditional medicine, products that did not fall within the categories of ‘medicines’ and ‘cosmetics’ and which were used during a healthcare professional’s treatment of a patient were, in a sense, regarded as medical devices. This included, to give a few examples, sterilised gloves and gauze, stretchers, equipment for carrying out tests on patients – or connected to them – restraint devices, prostheses and, of course, all types of medical instruments required by healthcare professionals.
However, This sector has experienced tremendous growth and as of today It is evolving very rapidly. And in the space of just a few decades, it has gone from being a sector regarded as ancillary – serving healthcare centres and professionals – to playing a much more significant role within the healthcare system as a whole.
In this regard, The way forward for health and beauty centres seems clear: tomorrow, those healthcare centres that have up-to-date equipment and -of course- With healthcare staff trained to use it, they will receive a significantly better standard of healthcare those who are unable to upgrade their equipment to the latest medical devices and train their staff to use this equipment efficiently.
From the 3D-printed prostheses, right through to sophisticated ones medical devices which enable the ‘scanning’ of nanoparticles in our bodies, the high-precision microscopes, which enable the detection of all kinds of conditions, or the healthcare mobile apps are good examples of how the health technologies are revolutionising the healthcare sector by creating new and improved medical devices,