Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: to be placed in the teeth, in which case they are in Class IIa, – to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are Class III,to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III, or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III and that there was Directive 2003/12/EC introduced a derogation from this rule, reclassifying breast implants in Class III.

Breast implants were reclassified by the FDA from Class II to Class III device, and I was curious to know which regulatory body made the reclassification first. As one would expect, the Directive 2003/12/EC by the EU was put in place in 2003. I was surprised to find that the FDA made the reclassification for breast implants from Class II to Class III in 1988. From the FDA website: In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm

http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf