Amendments to the medical device directive.
Variations in the transposition of the Medical Device Directive (MDD) by some countries has led to problems of interpretation and compliance, and there is still some way to go to achieve harmonization throughout Europe. This article suggests amendments to the MDD that should be introduced through the mechanism of the In Vitro Diagnostics Directive.
Cutler
I R
IR
European Regulatory Affairs for Smith and Nephew Europe, York Science Park, Heslington, UK.
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards* / Q000600:supply & distribution*; D005062:European Union; D006801:Humans; D008283:Maintenance; D008370:Manuals as Topic; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards