A Regulatory and Safety Perspective on Medical Devices

A Regulatory and Safety Perspective on Medical Devices

Carla Pires, Dinah Duarte
Copyright: © 2021 |Pages: 12
DOI: 10.4018/978-1-7998-3479-3.ch125
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In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.
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In Europe, medical devices market account for sales of EUR 100 billion, with the medical devices industry employing 575,000 people in the European Union (EU). This industry is one of the most representative employers in this economic area (European Commission, 2018). In 2015, the United States medical device market was evaluated at more than $140 billion, which represented nearly 45% of the global market (International Trade Administration, 2016). By 2021, the market of medical devices is expected to globally attain $342.9 billion, mainly due to the ageing of population (Lucintel, 2016). The main commercial trends in medical devices are, as follows: surgical and infection control, general medical devices, cardiovascular, and home healthcare. It is expected that in the future medical devices will tend to be smaller, portable, and including software (Lucintel, 2016).

The design and marketing of medical devices is strictly legislated. In accordance with World Health Organization (WHO) and Global Harmonization Task Force a medical device is defined as:

“an article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means” (WHO, 2018;Global Harmonization Task Force, 2012).

Additionally, the Food and Drug Administration (FDA) through the 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act defines a device as:

“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes” (FDA, 2018a,2018b).

Particularly, medical devices are regulated in accordance to Council Directive 93/42/EEC in the EU. According this Directive, all medical devices must be designed and manufactured in such a way, that, when used under the conditions and for the purposed intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. In addition, each member state of the EU has a National Competent Authority (NCA), which oversees specific designated Notified Bodies (NBs), i.e. the private entities, which are responsible for the certification of medical devices and for compliance of medical devices to EU Directives (Kramer et al., 2013; World Bank income group, 2016). NBs are responsible for evaluating the risk analysis and risk management strategy of the manufacturer (article 26 of Decree- Law No. 145/2016). In Portugal, the NCA - INFARMED, I.P. - is responsible for designating and supervising the national NBs (article 22º and 25º of Decree- Law No. 145/2016,) or for supervising the marketed medical devices (article 60º of Decree- Law No. 145/2016).

Key Terms in this Chapter

EUDAMED: A European database comprising commercial and safety information on medical devices.

Directive: A regulation/law in European Union.

INFARMED, I.P.: The Portuguese medicine agency.

Notified Bodies: A private entity responsible for certificating medical devices in accordance to law.

Note: CBIOS - Universidade Lusófona's Research Center for Biosciences and Health Technologies, Campo Grande, 376, 1749-024, Lisboa, Portugal.

Medical Device: A device for medical use, which may not be classified as a medicine.

Class I-III: The classes/classifications of medical devices in accordance to Annex of the IX, Council Directive 93/42/EEC.

Competent Authority: A public authority with specific competences in the commercialization medical devices.

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