CHAPTER III

IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

Identification within the supply chain
Article 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Medical devices nomenclature
Article 26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Unique Device Identification system
Article 27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

UDI database
Article 28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Registration of devices
Article 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electronic system for registration of economic operators
Article 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Registration of manufacturers, authorised representatives and importers
Article 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Summary of safety and clinical performance
Article 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

European database on medical devices
Article 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Functionality of Eudamed
Article 34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4O (with savings and transitional provisions for N.I. in reg. 3ZA) (as amended by S.I. 2019/791, regs. 1(1), 3(7) and by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2; and as amended (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 4, 32); 2020 c. 1, Sch. 5 para. 1(1))