SAFETY OF MEDICAL PRODUCTS AND DEVICES FOR MEDICAL USE

‘This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products’. However, ‘The scope of application of this Regulation should be clearly delimited from other legislation concerning products, such as medical devices, general laboratory products and products for research use only’ [Recitals n. 2, 7].

‘This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products’. However, ‘The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and food’ [Recitals n. 2, 7].

‘The health programme aims to improve Europeans’ health and reduce health inequalities by complementing Member States’ health policies in four ways. It is designed to: promote good health and prevent disease: here, countries would exchange information and good practices on how to deal with various risk factors such as smoking, drug and alcohol abuse, unhealthy diets and sedentary lifestyles; ensure that citizens are protected from cross-border health threats: increased international travel and trade mean that we are potentially exposed to a wider range of health threats than in the past, requiring a rapid and coordinated response; support innovation and sustainability in EU countries’ health systems: the programme seeks to help capacity building in the health sector, find optimal ways of making scarce resources go further and encourage the uptake of innovations in approaches, working practices, as well as technologies; improve access to quality and safe healthcare: this means, for example, ensuring that medical expertise is available beyond national borders by encouraging the creation of networks of centres of expertise across the EU’ [Source: http://eur-lex.europa.eu].

This Regulation authorisation decisions and post-authorisation efficacy studies for human medicinal products [Source: Recitals n. 1, 2].

This Implementing Regulation concerns quality systems for the performance of pharmacovigilance system [Source: Recital n. 5].

Regulation (EC) No 726/2004seeks to guarantee high standards of quality and safety of medicines, and includes measures to encourage innovation and competiveness. It sets out procedures for the authorisation and supervision of medicinal products for human and veterinary use and sets up the European Medicines Agency (EMA)’ [Source: http://eur-lex.europa.eu].

The aim of this Directive is to bring ‘together all the existing provisions in force on the sale, production, labelling, classification, distribution and advertising of medicinal products for human use in the EU’ [Source: http://eur-lex.europa.eu].

 

Council of Europe

‘The “Medicrime Convention” is the first international criminal law instrument to oblige States Parties to criminalise: the manufacturing of counterfeit medical products; supplying, offering to supply and trafficking in counterfeit medical products; the falsification of documents; the unauthorised manufacturing or supplying of medicinal products and the placing on the market of medical devices which do not comply with conformity requirements. The Convention provides a framework for national and international co-operation across the different sectors of the public administration, measures for coordination at national level, preventive measures for use by public and private sectors and protection of victims and witnesses. Furthermore, it foresees the establishment of a monitoring body to oversee the implementation of the Convention by the States Parties’ [Source: http://www.coe.int/].