The notified body shall have documented procedures in place for the review of the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects.
Beidh nósanna imeachta doiciméadaithe i bhfeidhm ag an gcomhlacht dá dtugtar fógra chun athbhreithniú a dhéanamh ar nósanna imeachta agus doiciméadacht an mhonaróra a bhaineann leis an meastóireacht ar ghnéithe réamhchliniciúla.