in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, 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 in aicme I nó i gcás feistí neamh-ionracha in aicme IIa agus in aicme IIb, mura sonraítear a mhalairt leis an dlí náisiúnta, díreach tar éis dháta bailíochtaithe an iarratais de bhun mhír 5, agus ar choinníoll nach ndearna an coiste eitice inniúil sa Bhallstát lena mbaineann tuairim dhiúltach maidir leis an imscrúdú cliniciúil, atá bailí don Bhallstát sin ina iomláine a thabhairt faoin dlí náisiúnta;