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- Title
Regulation of medicines and medical devices: contrasts and similarities.
- Authors
Parvizi, Nassim; Woods, Kent
- Abstract
In recent times, there has been an unprecedented level of public interest and active debate regarding the regulation of medical devices. This is in light of the topical, rather dissimilar, incidents involving poly-implant-prothèse (PIP) breast and metal-on-metal hip implants. Although medicines and devices are regulated under European Union (EU) law, the regulatory regimes are very different and some have argued that features of the pharmaceutical regime should be applied to medical devices in the current review of the medical devices directives. Both medicines and certain devices need to have an assessment of their risks and benefi ts before being used in patients, and undergo subsequent monitoring for adverse events. However, there are signifi cant differences between these two groups in terms of the number of products, the pattern of innovation and development, and the types of adverse events that arise from their use. This review will summarise the key issues through a comparison of how both are regulated and monitored.
- Subjects
EUROPEAN Union countries; UNITED Kingdom; DRUG laws; DRUG side effects laws; EQUIPMENT &; supplies; CLINICAL trials; DRUG approval; EUROPEAN Community; LAW
- Publication
Clinical Medicine, 2014, Vol 14, Issue 1, p6
- ISSN
1470-2118
- Publication type
Article
- DOI
10.7861/clinmedicine.14-1-6