COMMISSION DECISION
of 19 April 2010
on the European Databank on Medical Devices (Eudamed)
(notified under document C(2010) 2363)
(Text with EEA relevance)
(2010/227/EU)
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
Article 7
ANNEX
Directive 93/42/EEC |
Minimum data required for Eudamed data entry |
||||||||||||||||||||||||||||
Article 14a(1)(a) and Article 14(1) and (2) |
|
||||||||||||||||||||||||||||
Article 14a(1)(b) |
|
||||||||||||||||||||||||||||
Article 14a(1)(c) and Article 10(3) |
|
||||||||||||||||||||||||||||
Article 14a(1)(d) and Article 15(1), (6) and (7) |
|
||||||||||||||||||||||||||||
Directive 90/385/EEC |
Minimum data required for Eudamed data entry |
||||||||||||||||||||||||||||
Article 10b(1)(a) |
|
||||||||||||||||||||||||||||
Article 10b(1)(b) and Article 8(3) |
|
||||||||||||||||||||||||||||
Article 10b(1)(c) and Article 10(1), (3) and (4) |
|
||||||||||||||||||||||||||||
Directive 98/79/EC |
Minimum data required for Eudamed data entry |
||||||||||||||||||||||||||||
Article 12(1)(a) and Article 10(1), (3) and (4) and Annex VIII (4) |
|
||||||||||||||||||||||||||||
Article 12(1)(b) |
|
||||||||||||||||||||||||||||
Article 12(1)(c) and Article 11(3) |
|