It will be the responsibility of the company to identify the requirements applicable to its product, as well as to itself as an economic agent in the medical device sector.
In the case of medical device manufacturing companies, they must inexcusably put CE-marked medical products on the market, with the rest of the economic agents (distributor, importer or authorized representative) being responsible for ensuring that the product with which they have a relationship is available.
The requirements applicable to the medical device depend, to a large extent, on the properties and characteristics of the product itself. The requirements applicable to the specific product will mainly depend on its classification as a medical device, its intended purpose, its risk analysis and its clinical evaluation.
Regulatory framework for health products or medical devices.
Understanding the horizon of the regulatory framework for health products or Medical Devices means understanding what it means that our country belongs to a union of countries. And that, within the scope of that unit, measures are established to homogenize the treatment of issues of special importance. For which rules are issued that affect and involve all states in the same way.
European regulatory framework.
First of all, we must refer to community legislation. And, in this framework, to the new features 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, Regulation (EU) 2017/745 regarding 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 (Unique Product Identification) code. Which must be registered in a centralized database in the European Union: EUDAMED.
This new regulation has marked the beginning of a new era for manufacturers. Well, it has led them to allocate time and resources to adapt their processes.
Marco regulatorio nacional
Para comprender el marco regulatorio de los productos sanitarios o medical devices en nuestro país, hay que fijar la atención sobre la Agencia Española del Medicamento. Es importante atender a las indicaciones de este organismo dependiente del gobierno central. El cual, cada año revisa, regula, controla o autoriza medicamentos, ensayos clínicos, productos sanitarios, etc.
Además es el encargado de especificar la legislación donde encontrar parámetros específicos. Y, siguiendo a la AEMPS, entre otros textos legales, destacamos:
- Real Decreto 1591/2009 por el que se regulan los productos sanitarios.
- Real Decreto 1090/2015 por el que se regulan los ensayos clínicos, los Comités de la Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos.