where the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose, provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; or
i gcás inar dearadh an fheiste trí fheiste eile a mhodhnú a chuir an monaróir ar an margadh cheana féin agus an chrích chéanna beartaithe di, ar choinníoll gur léirigh an monaróir chun sásaimh an chomhlachta dá dtugtar fóga nach ndéanann na modhnuithe dochar don chóimheas tairbhe-riosca leis na modhnuithe sin; nó