By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose.
De mhaolú ar Airteagal 5 den Rialachán seo, ní fhéadfar feiste a bhfuil deimhniú aici, ar deimhniú é a eisíodh i gcomhréir le Treoir 98/79/CE agus atá bailí de bhua mhír 2 den Airteagal seo, a chur ar an margadh ná a chur i seirbhís ach ar choinníoll, ó dháta chur i bhfeidhm an Rialacháin seo, go leanann sé den Treoir sin a chomhlíonadh, agus ar choinníoll nach bhfuil aon athruithe suntasacha ar an dearadh ná ar an gcuspóir dá bhfuil sí beartaithe.