title: Regulation of medicines and medical devices: contrasts and similarities.
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 benefits before being used in patients, and undergo subsequent monitoring for adverse events. However, there are significant 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.
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, London, UK.
authors.forename: Nassim
authors.initials: N
authors.lastname: Parvizi
authors.forename: Kent
authors.initials: K
authors.lastname: Woods
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D060735:Pharmacovigilance; D016032:Randomized Controlled Trials as Topic; D006113:United Kingdom
keywords: Regulation; adverse event; medical devices; medicines