The regulatory framework for medical devices is a primary issue since it establishes the guidelines to be met by these types of products in relation to the different areas. Thus, both manufacturers and distributors or authorized representatives must be fully informed of the applicable regulations. And in the same way, it is also important that users know as well as possible the conditions that these types of articles must meet.

Importance of the regulatory framework for medical devices

The reason for this need for up-to-date information is to ensure compliance with the law. Ultimately, this is the only way to guarantee the welfare of taxpayers. But, at the same time, it enables active subjects to carry out their work with the greatest security.

The importance of the regulation of medical devices, as well as their knowledge, is not lost on anyone. Let’s not forget that we are talking about especially delicate products above all, given their link with the health and well-being of people. And because, sometimes, they involve a direct intervention on the human body.

In light of the foregoing, the exhaustive controls to which these products are subjected are motivated by their consideration as essential. And this is reflected in the extensive regulation in such a way that there is a guarantee of protection, in the event of a breach of legal requirements.

On the other hand, such legislative density contributes to providing the subjects in charge of handling these medical devices with the data they need to carry out their functions. Because it is about regulating everything: their production, but also their distribution, sale and use in addition to other related topics.

Regulatory framework for health products or medical devices

Understanding the horizon of the regulatory framework of Medical Devices means understanding what it means that our country belongs to a union of countries. And that, within the scope of this unit, means that measures are established to standardize the treatment of issues of special importance. For this, rules are issued that affect and involve all states in the same way.

European regulatory framework

First, you have to refer to Community legislation. And, within this framework, to the novelties introduced by the most recent European regulations on the regulation of medical devices. We are talking about a regulation that came into force on May 25, 2017, namely Regulation (EU) 2017/745 on medical devices, with an application date scheduled for May 25, 2021.

The repeal and replacement of the old legislation (Directive 93/42 / EEC) created a new regulatory framework that imposed new conditions. Among them, the need to implement a UDI code (Unique Product Identification) which must be registered in a centralized database in the European Union: EUDAMED.

This new regulation has marked the beginning of a new stage for manufacturers. Well, it has led them to allocate time and resources to adapt their processes.

National regulatory framework

To understand the regulatory framework of health products or medical devices in our country, we must pay attention to the Spanish Agency for Medicines. It is important to heed the indications of this body dependent on the central government which every year reviews, regulates, controls or authorizes drugs, clinical trials, health products, etc.

It is also in charge of specifying the legislation where to find specific parameters. And, following the AEMPS, among other legal texts, we highlight:

  • Royal Decree 1591/2009 which regulates medical devices.
  • Royal Decree 1090/2015 which regulates clinical trials, the Ethics Committees for Drug Research and the Spanish Registry of Clinical Studies.

IP Triana

At IP Triana, we are aware of the regulatory complexity that affects our sector. That is why we work every day to update our knowledge and thus offer our customers a final product with all the guarantees, including the CE marking.

We have a wide catalogue available for you. Contact us and let’s talk!

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