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Authors
Abstract(s)
Investigação
No contexto atual de gestão de qualidade no que diz respeito a dispositivos médicos de
diagnóstico in vitro, a alteração regulamentar verificada pela publicação do Regulamento
UE 2017/746 do Parlamento e do Conselho Europeu, conhecido de um modo generalizado
pela sigla “IVDR”, verifica um aumento significativo dos requisitos exigidos aplicáveis em
matéria de segurança e desempenho, a dispositivos, comercializados na União Europeia e
no seu espaço económico. O regulamento UE 2017/746, no qual é fundamentada a
dissertação e que, daqui em diante, referido por IVDR, surgiu na sequência da identificação,
por parte da Comissão Europeia, de fragilidades, na disponibilização indevida de
dispositivos de diagnóstico em condições precárias e de elevada irregularidade, uma vez que
a legislação até então, carecia de linhas de orientação claras e requisitos ou exigências
mínimas adequadas, para assegurar a conformidade do dispositivo. Neste sentido, é
requerida a aplicação conjunta do IVDR e do normativo harmonizado EN ISO 13485:2016
– Sistema de Gestão de Qualidade para Dispositivos Médicos de Diagnóstico in Vitro, no
que refere a Sistemas de Gestão de Qualidade, para fabricantes e restantes intervenientes
do processo relacionado à conceção, disponibilização, comercialização e monitorização de
dispositivos médicos de diagnóstico in vitro.
Na presente dissertação pretende-se efetuar uma revisão do conhecimento adquirido no
regulamento IVDR, nomeadamente a nível de perspetiva de fabricantes de dispositivos
médicos de diagnóstico in vitro, bem como, através da experiência de implementação
desenvolver sugestões de linhas orientadores de estratégia para implementação do IVDR
em paralelo com o referencial EN ISO 13485:2016.
A investigação desenvolveu-se em duas etapas: uma primeira etapa de revisão do
conhecimento adquirido no regulamento IVDR, e uma segunda etapa, de recolha e análise
de resultados, nomeadamente a nível de perspetiva de fabricantes de dispositivos médicos
de diagnóstico in vitro. Particularmente, a segunda etapa foi efetuada por fases: a fase 1 que
consiste numa revisão sistemática ao conhecimento adquirido e publicado pela comunidade
científica em matéria de IVDR e normativos de qualidade aplicáveis. Procurou retratar-se a
perspetiva do fabricante com relação à aplicação do IVDR e quais as situações mais
prementes na adaptação ao mesmo, através da metodologia PRISMA adaptada ao tema de
estudo, tendo em conta a possibilidade de viés, verificada com a ferramenta CASP e
aplicando a ferramenta de avaliação qualitativa da HCPRDU. A fase 2, por sua vez, detalha
o trabalho desenvolvido em atividades de implementação em contexto de indústria, através da adaptação do Sistema de Gestão de Qualidade pelo referencial EN ISO 13485:2016, na
organização ALS Life Sciences Portugal. Esta organização da qual sou colaboradora, é
fabricante de dispositivos médicos de diagnóstico in vitro, pelo que carece também da
aplicação do IVDR no seu contexto.
Deste modo, verifica-se a ocorrência de uma convergência de opiniões, com as já obtidas,
da revisão da literatura de fase 1, em medida de dificuldades identificadas e procedimentos
para resolução das mesmas. Destacam-se as questões relacionadas com o Anexo I do IVDR
– Requisitos Gerais de Segurança e Desempenho. Acredita-se com esta investigação que
existe espaço para melhoria e colaboração, que poderá vir a ser fundamental, entre
entidades no setor de dispositivos médicos de diagnóstico in vitro.
Farmácia Comunitária
O Capítulo 3 da dissertação, incide sobre a temática de farmácia comunitária,
nomeadamente o funcionamento interno da farmácia bem como os sistemas aplicados. Na
Farmácia Moura, local de estágio, é aplicado o referencial de Sistema de Qualidade, EN ISO
9001. Deste modo o trabalho desenvolvido incide, de forma não exaustiva, sobre os
principais pontos aplicáveis da norma, nomeadamente o controlo de processos, controlo de
documentação e operacionalização dos serviços.
O Capítulo 3 em questão indica também os serviços adicionais desempenhados pela
farmácia, bem como alguns casos clínicos, presenciados na farmácia e que embora de
gravidade moderada, espelham a realidade dos profissionais em Portugal e devem,
portanto, ser abordadas.
In the current context of quality management with regard to in vitro diagnostic medical devices, the regulatory change brought about by the publication of Regulation EU 2017/746 of the European Parliament and of the Council, known generally by the acronym "IVDR", has seen a significant increase in the safety and performance requirements applicable to devices marketed in the European Union and its economic area. Regulation EU 2017/746, on which this dissertation is based and which is hereafter referred to as IVDR, came about following the European Commission's identification of weaknesses in the improper provision of diagnostic devices in precarious and highly irregular conditions, since the legislation until then lacked clear guidelines and adequate minimum requirements or demands to ensure the device's conformity. In this sense, the joint application of the IVDR and the harmonised standard EN ISO 13485:2016 - Quality Management System for In Vitro Diagnostic Medical Devices, with regard to Quality Management Systems, is required for manufacturers and other stakeholders in the process related to the design, availability, marketing and monitoring of in vitro diagnostic medical devices. The aim of this dissertation is to review the knowledge acquired on the IVDR regulation, particularly from the perspective of manufacturers of in vitro diagnostic medical devices, as well as to develop suggestions for strategy guidelines for implementing the IVDR in parallel with the EN ISO 13485:2016 reference. The research was carried out in two stages: a first stage of reviewing the knowledge acquired on the IVDR regulation, and a second stage of collecting and analysing results, particularly from the perspective of manufacturers of in vitro diagnostic medical devices. In particular, the second stage was carried out in phases: phase 1 consisting of a systematic review of the knowledge acquired and published by the scientific community on IVDR and applicable quality regulations. It sought to portray the manufacturer's perspective on the application of the IVDR and the most pressing situations in adapting to it, using the PRISMA methodology adapted to the subject of study, taking into account the possibility of bias, verified with the CASP tool and applying the HCPRDU qualitative assessment tool. Phase 2, in turn, details the work carried out in implementation activities in an industrial context, through the adaptation of the Quality Management System using the EN ISO 13485 reference, in the ALS Life Sciences Portugal organisation. This organisation, of which I am a collaborator, is a manufacturer of in vitro diagnostic medical devices and therefore also needs to apply the IVDR in its context. As a result, there is a convergence of opinions with those already obtained from the phase 1 literature review, in terms of the difficulties identified and the procedures for resolving them. Of particular note are the issues related to Annex I of the IVDR - General Safety and Performance Requirements. This research shows that there is room for improvement and collaboration, which could be fundamental, between organisations in the in vitro diagnostic medical device sector. Community Pharmacy Chapter 3 of the dissertation focuses on the topic of community pharmacy, namely the internal functioning of the pharmacy as well as the systems applied. At Farmácia Moura, the internship site, the Quality System reference, EN ISO 9001, is applied. In this way the work carried out focuses, in a non-exhaustive way, on the main applicable points of the standard, namely process control, documentation control and operationalization of services. The Chapter 3 in question also indicates the additional services performed by the pharmacy, as well as some clinical cases, witnessed in the pharmacy and which, although of moderate severity, reflect the reality of professionals in Portugal and must therefore be addressed.
In the current context of quality management with regard to in vitro diagnostic medical devices, the regulatory change brought about by the publication of Regulation EU 2017/746 of the European Parliament and of the Council, known generally by the acronym "IVDR", has seen a significant increase in the safety and performance requirements applicable to devices marketed in the European Union and its economic area. Regulation EU 2017/746, on which this dissertation is based and which is hereafter referred to as IVDR, came about following the European Commission's identification of weaknesses in the improper provision of diagnostic devices in precarious and highly irregular conditions, since the legislation until then lacked clear guidelines and adequate minimum requirements or demands to ensure the device's conformity. In this sense, the joint application of the IVDR and the harmonised standard EN ISO 13485:2016 - Quality Management System for In Vitro Diagnostic Medical Devices, with regard to Quality Management Systems, is required for manufacturers and other stakeholders in the process related to the design, availability, marketing and monitoring of in vitro diagnostic medical devices. The aim of this dissertation is to review the knowledge acquired on the IVDR regulation, particularly from the perspective of manufacturers of in vitro diagnostic medical devices, as well as to develop suggestions for strategy guidelines for implementing the IVDR in parallel with the EN ISO 13485:2016 reference. The research was carried out in two stages: a first stage of reviewing the knowledge acquired on the IVDR regulation, and a second stage of collecting and analysing results, particularly from the perspective of manufacturers of in vitro diagnostic medical devices. In particular, the second stage was carried out in phases: phase 1 consisting of a systematic review of the knowledge acquired and published by the scientific community on IVDR and applicable quality regulations. It sought to portray the manufacturer's perspective on the application of the IVDR and the most pressing situations in adapting to it, using the PRISMA methodology adapted to the subject of study, taking into account the possibility of bias, verified with the CASP tool and applying the HCPRDU qualitative assessment tool. Phase 2, in turn, details the work carried out in implementation activities in an industrial context, through the adaptation of the Quality Management System using the EN ISO 13485 reference, in the ALS Life Sciences Portugal organisation. This organisation, of which I am a collaborator, is a manufacturer of in vitro diagnostic medical devices and therefore also needs to apply the IVDR in its context. As a result, there is a convergence of opinions with those already obtained from the phase 1 literature review, in terms of the difficulties identified and the procedures for resolving them. Of particular note are the issues related to Annex I of the IVDR - General Safety and Performance Requirements. This research shows that there is room for improvement and collaboration, which could be fundamental, between organisations in the in vitro diagnostic medical device sector. Community Pharmacy Chapter 3 of the dissertation focuses on the topic of community pharmacy, namely the internal functioning of the pharmacy as well as the systems applied. At Farmácia Moura, the internship site, the Quality System reference, EN ISO 9001, is applied. In this way the work carried out focuses, in a non-exhaustive way, on the main applicable points of the standard, namely process control, documentation control and operationalization of services. The Chapter 3 in question also indicates the additional services performed by the pharmacy, as well as some clinical cases, witnessed in the pharmacy and which, although of moderate severity, reflect the reality of professionals in Portugal and must therefore be addressed.
Description
Keywords
Dispositivo Médico de Diagnóstico in Vitro Farmácia Comunitária Iso Ivdr Qualidade