New Italian device registration requirements.
A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer's devices in Italy in a new online data bank. This is incorrect. This article discusses the new requirements for registering medical devices in Italy, together with the steps in the registration process and common problems encountered.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D003132:Commerce / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000191:economics / Q000600:supply & distribution*; D040362:Geographic Information Systems / Q000458:organization & administration; D033161:Government Regulation; D017408:Guidelines as Topic; D007558:Italy; D019221:Mandatory Reporting; D011356:Product Labeling / Q000331:legislation & jurisprudence; D009626:Terminology as Topic