in the case of investigational devices, other than those referred to in point (a), as soon as the Member State concerned has notified the sponsor of its authorisation, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation.
i gcás feistí imscrúdaitheacha seachas na cinn sin dá dtagraítear i bpointe (a), a luaithe a bheidh fógra tugtha ag an mBallstát lena mbaineann don urraitheoir faoina údarú, agus ar choinníoll nach ndearna an coiste eitice sa Bhallstát lena mbaineann tuairim dhiúltach maidir leis an imscrúdú cliniciúil, atá bailí don Bhallstát sin ina iomláine a thabhairt faoin dlí náisiúnta.