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HRA requirement for Legal Rep?

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  • Jane Humphreys
    03/02/2016 11:03
    I am acting for a Swedish Sponsor to gain approvals to medical device studies in the UK. Following REC approval and CE-marking and confirmation that the device is being used for its intended purpose, the R&D approval from NIHR/CRN at North Thames insists that we need a UK-based Legal Rep. This is more stringent than the rules for CTIMPs - is it an unintended consequence?
  • Medical Device Committee
    25/05/2016 11:36
    An (EU/EC) European Authorised Representative (also called Authorised Representative) is a natural or legal person established in the EU who, explicitly designated by a non-Euroepan manufacturer, acts on his behalf in carrying out certain tasks required in the applicable directives. A UK rep is therefore not required as the sponsor is in Sweden, would suggest you contact the CRN and explain as they may have misunderstood the requirements.
  • Medical Device Committee
    25/05/2016 13:52
    One observation would be that the company/organisation based in Sweden sponsoring the trial may not be the owner/legal manufacturer of the CE marked device. In this case if the legal manufacturer of the CE marked device is not based in the EU then a EU based Authorised Representative will be required. The Swedish sponsor will need to clarify with the investigational site if they are the legal manufacturer of the device or conducting the trial using a third party CE marked device and if so, where the third party is based.
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