CE marking as a necessary requirement of free marketing products.
Journal Title: Polish Journal of Public Health - Year 2009, Vol 119, Issue 1
Abstract
Introduction of the New and Global Approach to the European Union has considerably changed the attitude to safety of industrial products as well. A new concept of conformity assessment has been adopted, and the compliance with requirements of the New Approach technical directives has been expressed in the CE marking. CE marking is obligatory. Failure to comply with the solutions relating to CE marking results in sanctions, also economic. CE marking and all the associated consequences are applicable to marketing and use of medical products, except for medical products made to order, for clinical trials, and medical products for evaluating performance of in vitro diagnostics. The issue of marketing and use of medical products and procedures of CE marking applied to medical products are discussed in the present paper.
Authors and Affiliations
Regina Borek-Wojciechowska, Sylwia Kłokow
Keywords
Related Articles
- EP ID EP160213
- DOI -
- Views 88
- Downloads 0
Bacterial sexually transmitted-diseases – the threat of the 21st century
The bacterial STDs have been always a part of human life. Societies from all over the world tackle with this relevant health problem. Three hundred and forty million of new STD cases are revealed every year according to...
Selected aspects of quality of life in parents of children with bronchial asthma
[b]Introduction[/b]. Bronchial asthma is the most frequent chronic childhood disease of increasing morbidity. In the light of recent knowledge asthma requires complex treatment and involves child’s family in long-term th...
Ochrona patentowa produktów leczniczych – negatywne aspekty, alternatywne rozwiązania
Ochrona patentowa produktów farmaceutycznych jest wyjątkowo rozbudowana i wynika ze specyficznego charakteru dobra, którego dotyczy. Stosowanie ochrony własności intelektualnej w tym przypadku usprawiedliwiają argumenty...
Wybrane elementy stylu życia i problemy zdrowotne osób po 50 roku życia
[b]Wprowadzenie[/b]. Współczesne społeczeństwo należy do starzejących się. Osoby w wieku poprodukcyjnym w Polsce coraz częściej i chętniej korzystają nie tylko z leków i usług, które utrzymują je jak najdłużej w dobrym z...
The WHO Healthy Cities project realisation in Poland in last few years
The WHO Healthy Cities project is a global movement. It engages local governments in health development through a process of political commitment, institutional change, capacity-building, partnership-based planning and i...