A

B

C

  • CE-conformity marking (Art. 20, Annex V)
  • Certificates see EU certificates
  • Classification (Art. 51)
  • Classification rules (Annex VIII)
  • Clinical evaluation (Art. 61, Anhang XIV)
  • Clinical data (Art. 2,48)
  • Post-marketing clinical follow up (Annex XIV)
  • Clinical trial (Annex XV)
  • Conformity assessment (Art. 2,40)
  • Conformity assessment procedure (Art. 52)
    • Class I (Art. 52,7)
    • Class I, sterile, maserung function, reusable surgical (Art. 52,7)
    • Class IIa (Art. 52,6)
    • Class IIb
    • Class IIb implantable, exempted
    • Class IIb implantable, not exempted (Art. 52,4)
    • Class III (Art. 52,3)
  • Consultation procedure 
    • The MDR includes 3 Consultation procedures
      • Medical devices incorporating  medicinals
      • Medical devices animal / human origin
      • Specific medical devices class III and IIB, Kontrolle der klinischen Bewertung (Anh. IX 5.1)
  • Common Specifications 'CS' (Art. 2,71), (Art. 9)
  • Custom-made device (Art. 2,3)

D

E

  • Economic operator (Art. 2,35)
  • EU Certificates
    • EU Quality management system certificate (Ann. IX, 2.3)
    • EU Technical documentation assessment certificate (Ann. IX, 4.9)
    • EU-Declaration of conformity (Art. 19, Ann. IV)
  • EUDAMED European database for medical devices (Art. 33, 34)

F

  • Free sales certificates FSC (Art. 60)

G

 

H 

I 

K 

L 

M 

  • Manufacturer (Art. 2,30)
  • Medical Device  (Art. 2,1)
  • MDCG (Medical Devices Coorpination Group) (82), (Art. 103), (Art. 105)

N 

  • Nanomaterial  (Art. 2,18)
  • Nomenclature for Medical Devices (Art. 26)
  • Notified Body (Art.2,42), (Art. 36-50)

P 

  • Parts and Components (Art. 23)
  • Performance  (Art. 2,22)
  • Placing on the market (Art. 2,28), (Art. 5)
  • Post Market Surveillance
  • Post market clinical follow up (Ann.XIV,B)
  • Procedure Pack (Art. 2,10)
  • Putting into service (Art. 2,29), (Art. 5)

R

S

 T

  • Technical Documentation (Ann II)
  • Technical Documentation, Post Marketing (Ann. III)
  • Transition (Art. 120)

U

  • UDI-Database (Art. 28)
  • UDI  "Unique device identifier" (Art. 2,15), (Art. 27, Ann. VI Part C)
  • User (Art. 2,37)

 

V

W

Z

 

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