Espacios. Espacios. Vol. 30 (2) 2009. Pág. 28
Desiree Moraes Zouain * y Marco Antonio Grecco D’Elia**.
Recibido: - Aprobado
The comparison of electro medical equipments regulations in Brazil and European Union shows that the adopted models have many similarities, although there are differences on applications which turn the European regulation more exigent.
The European regulation allows the producer to choose many ways to get the CE mark according to equipment class, being possible the conformity self-declaration in the simplest case and the producer can choose to attend the harmonized standards or demonstrate conformance to the essential requirements by other more convenient way. In Brazil the certification process is similar to all equipments, independent of the potential risk class, and these equipments have to demonstrate the conformity to Brazilian standards.
About the electrical medical equipments standards, both in European Union and in Brazil are adopted the IEC standards as reference, but in Brazil the reviews do not follow, in many cases, the IEC earlier reviews, what happens in European Union as, for instance, the adoption in 2008 of the third edition (2005) of the standard IEC 60601-1 – General Standard. Regarding to particular standards, is evident the delay of reviews (editions) among the Brazilian standards (NBR) comparing to correspondents IEC standards.
In the case of quality systems assessment, the Brazilian regulation is less rigorous, establishing the standard ISO 9001:2000 as reference, while in European Union the reference is the standard ISO 13.485:2005, derivate from the ISO 9001:2000 and specific to medical devices sector.
The electrical medical potential risk management will be, by 2008, with the definitive adoption of IEC 60601-1:2005, the determine factor to CE marking, in order it require the equipment have to be evaluated using risk management, according to standard ISO 14.971:2007, recently published.
With the survey and data analysis, it was possible to infer that there are not exactly technical barriers in European Union to the Brazilian electrical medical equipments, since the standards are international and the assessment procedures are available and transparent. Actually, there are “pseudo technical barriers” due to the technical, financial and cultural limitations of small and medium companies.
Technical limitations can be overcome through partnerships, projects and support of technological and research centers and universities, which have capable experts and laboratories to support the small and medium companies. The financial limitations can be partially overcome through public founds and financing programs conducted by government agencies, although the entrepreneurship investment is determinant. The cultural limitations can be overcome through the companies’ participation on business international fairs and congresses, through the partnership with European Union representatives who have established structure to commercialization, distribution and technical assistance, and through the experience learned.
However, according to the survey results must be mentioned that the companies have relatively few professionals with advanced academic degree (master and doctor degree) on technological area, what is a limiting factor to technological based companies.
Other important aspect is the necessity of companies’ participation on technical standards elaboration process, on national and international scope, if not to influence, at least to know previously the technical requirements, that tends to be more rigorous and restrictive, and have enough time to adequate the products and process, and to develop the necessary innovations.
At last, a procedure was prepared pointing the main steps to be followed to the electrical medical equipments adequation according to the requirements established on Medical Devices Directive - MDD 93/42 and consequent CE marking, needed to put the product into that marked. In this way, the procedure can be used as a guide to small and medium companies which produces electrical medical equipments, so far as a model to others industrial sectors.
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