Companies must adapt their products to the European regulatory framework

Presentations by María Aláez, Technical Director of Fenin:

• Productos sanitarios: definiciones y clasificación |  See | Download (pdf)
• Evaluación clínica de productos sanitarios | See | Download (pdf)
• Aplicación de la gestión de riesgos en productos sanitarios | Vee| Download (pdf)

Around forty professionals and businessmen from healthcare technologies participated in the advisory programme The regulatory labyrinth: what to ask the experts, promoted by Biocat and the Spanish Federation of Healthcare Technology Companies (Fenin).

The two plenary sessions held on 10 and 26 November aim to provide answers to the doubts on the manufacturing and marketing of healthcare products in the current regulatory framework, so that the companies may incorporate the regulatory strategy and identify the most appropriate professionals for their projects. The programme will close in January 2011 with ten personalised advisory sessions for young companies interested in finding answers to specific subjects.

This advisory programme originated as the result of the needs identified in the strategic medical technologies plan and the workshop IP Strategy and Regulatory Framework for Medical Devices, organised by Biocat in May 2009, in which participated nearly 100 businessmen and professionals of the industry.

The plenary sessions were led by María Aláez, Technical Director of Fenin, who on the first day analysed four general points: sources of information on the current legislation, planned legislative changes and their impact, process and costs of CE homologation and the launching of new products on the market. During the second day more specific subjects were taken up, identified by the participants in the programme: clarification of product definitions and classification, clinical evaluation, risk analysis, vigilance system and funding of healthcare products.

Aláez has defined, in the first place, the healthcare products as “any instrument, apparatus, appliance, software, material or other type of article intended by its manufacturer to be used for specific diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings".

Up to the 1980s each State had (or did not have) its own regulatory framework regarding healthcare products. It was then that an attempt was made for global regulation in the European market with the intention of making the market more competitive. The resulting regulatory model, referred to as the New Approach, evolved up to now and has established “cohesion, free European circulation of the products, a flexible framework and innovation, in addition to safety and protection of health and the environment”, according to Aláez.

Current legislation requires the companies to comply with essential requisites in order to offer and guarantee the protection of the product depending on the area to which it may pertain. With some technical standards to follow and procedures for the evaluation of the compliance set forth in the applicable directive.

Products with European certification

So that a product may obtain European certification (CE), two roads can be followed according to the risk level. On the one hand, the companies can be self-certified under their own responsibility if the risk level of the product is low, whenever it complies with some guidelines marked by the European Commission. If the risk level is medium or high, the certification must be granted by a notified body (independent bodies that certify the compliance of the products with the current directives according to an approach based on independence, transparency and confidentiality).

The Spanish Agency of Medicines and Medical Devices (AEMPS) is the only notified body accredited in Spain, although one can also turn to European notified bodies to obtain this certification. In addition to AEMPS, the autonomous regions also have competences when regulating the marketing of these products. 

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