The Commission shall, no later than five years from the date of implementation of this Directive, submit a report to the Council on the operation of the provisions referred to in Article 10 (1), Article 15 (1), in particular in respect of Class I and Class IIa devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appropriate proposals.
Komisija najkasneje pet let po datumu začetka izvajanja te direktive predloži Svetu poročilo o izvajanju določb iz členov 10(1) in 15(1), zlasti glede pripomočkov v razredih I in IIa, ter o izvajanju določb Priloge II te direktive, oddelka 4.3, drugega in tretjega pododstavka, in Priloge III te direktive, odddelka 5, drugega in tretjega pododstavka, po potrebi skupaj z ustreznimi ukrepi.