Manufacturing a medical device, whatever it may be, is an action for which a company needs to be specially prepared since its production requires the fulfilment of very demanding requirements. This is really very easy to understand, since we are talking about products related to the health of those who are going to use them.

For all this, the European and Spanish authorities have developed a wide variety of legal texts in which multiple aspects related to the manufacture of sanitary products of all kinds are regulated.

What is a medical device?

To manufacture a medical device, the most logical thing is to know, first of all, what it is to determine which articles fall within this definition.

Assuming the complexity of the issue, it is important to explore the abundant legislation that addresses the issue.

Related legislation

In Spain, we must take as reference the guidelines of the Spanish Agency of Medicines since it is responsible for defining the legal framework for the manufacture of a medical device. And you have to go to it to find out first-hand everything you need to know.

In this sense, it must be said that the laws are numerous and cover a wide variety of topics. But the truth is that there are two texts whose consultation is essential:


Royal Decree 437/2002 establishes the criteria for the granting of operating licenses to manufacturers of customized medical devices.


Royal Decree 1591/2009 regulates medical devices.

The regulations covered by these two national texts are aimed at complying with what is contained in the European regulations which can be seen in a simple way if you take as a reference Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.

Besides these texts, there are many other documents and some of them have been specially designed to guide the application of the different regulations. In the same way, in our country, there are also Orders and other more specific Decrees.



If we study this regulation, one of the first articles (number 2) of RD 1591/2009 explains what medical devices consist of and it talks about instruments, devices, equipment, computer programs, materials or any other items. But it also reveals that they must always be used for a specific function which can be to diagnose, prevent, treat, control or alleviate a disease, injury or deficiency.

Finally, it also refers to those that are used to investigate, replace or modify the anatomy of a physiological process or to regulate conception.

What we have just explained is taken as a general definition but it is possible to add various features to it and thus define other types of sanitary products: made to measure, for hospital use or “in house”, among others.

In any case, one idea is clear under all laws, namely that these are articles whose production must be monitored very carefully due to their destination.

Some requirements to manufacture a medical device

For technical and legal purposes, a company will consider itself ready to manufacture a medical device if it meets certain requirements, such as:


– Having a guaranteed quality system.

In this aspect, the law is very clear. Both the production and the storage of a medical device must be done keeping strict quality parameters. And this aspect is guaranteed thanks to the recognition of the ISO 13485 standard.

The recognition of this quality parameter has various implications, the main one being that the products are considered to meet the legal requirements for their manufacture and that they will be adapted to the use for which they are intended.


– Going through laboratory tests, and obtaining the corresponding certifications.

Laboratories that are legally accredited for this purpose are in charge of verifying that the articles meet the necessary requirements in order to ensure that they are suitable for use. They also carry out the verification of the documentation attached to the products.


– The mandatory CE marking.

Finding the CE mark on a product means that it meets all regulatory requirements. This mark always covers everything related to its manufacture and its use.

The CE mark is translated as European Conformity, as indicated by the translation of its acronym, which in French is “Conformité Europénne”, although it is generally known as the Conformity Marking.

Manufacturing processes.

The manufacturing process of a medical device must meet, in each case, the conditions that the different laws stipulate for it. Also, according to this, all moments of production must conform to the specific regulatory framework.

IP Triana

At IP Triana, we have been working for the pharmaceutical industry for 60 years, taking care of the quality of all our processes at every step.

A recognized quality management system and facilities that meet the optimal conditions guarantee us, in addition to a trajectory marked by a concern for customer satisfaction.

We put a team of specialized professionals at your service. Contact us and tell us what you need.


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