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?直接供给的卫生机构或医疗保健专业人员(Article 25).
? Store and keep the UDI for implantable devices by economic operators (Article 27.8)
? Electronic system for registration of economic operators (Article 30+Annex VI, Part A)

 Regulatorypliance
? It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer’sanisation by a person responsible for regulatorypliance who fulfils minimum conditions of qualification.

? The authorised representative plays a pivotal role in ensuring thepliance of the devices produced by those manufacturers and in serving as their contact person established in the Union… legally liable for defective devices in the event that a manufacturer
 established outside the Union has notplied with its general
 obligations