Medical device directive: preparing for the amendments.
Article 21 of the In Vitro Diagnostic (IVD) Directive (98/79/EC) contains several important amendments to the Medical Device (MD) Directive (93/42/EEC). This is generally well known. However, the amendments are not always being kept in mind when discussing the requirements of the MD Directive. This article reviews the more important amendments and suggests that it is time to begin planning for them. The new definition of IVD products is also provided.
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
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D018795:Device Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D017408:Guidelines as Topic