Yes. CE-MDR (the EU Medical Device Regulation, under which all medical devices sold in the EU must be classified and obtain CE marking) classifies products by risk into Class I, IIa, IIb, and III. If a massager claims medical uses such as pain relief or promoting blood circulation, it is very likely to be classified as Class IIa, requiring involvement of a Notified Body (NB). Misclassification directly leads to incomplete technical documentation, and the product will be delisted or detained during Amazon reviews or EU customs spot checks. It is recommended to first self-check against the classification rules in MDR Annex VIII, then decide whether to adjust claims or supplement NB certification. Reference timeline: Class IIa NB certification takes about 90–180 working days; reference cost range: 30,000–150,000 RMB.
Many sellers sell massagers as ordinary household appliances, but once words such as "treatment" or "anti-inflammatory" appear on the detail page, the product is regarded as a medical device. Shuwang Testing and Certification Platform recommends: first make a classification determination, then prepare technical documentation (TCF), and have the NB issue the certificate. Incorrect classification determination is the most time-consuming part of remediation; the earlier it is corrected, the lower the cost. Reference: https://www.shuwangtc.com