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Notification Detail :: G/TBT/N/EU/1084
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Draft Commission Implementing Regulation amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council
Objective
Protection of human health or safety (TBT); Harmonization (TBT)
Product Covered
In vitro diagnostic medical devices
Document Notification
Link to ePing
HSCODE
ICSCODE
11.040 - Medical equipment
Keywords
Human health
Specific Regions
Additional Data
Description
This draft Commission Implementing Regulation adds common specifications for some high-risk in vitro diagnostic medical devices in accordance with Art. 9 of Regulation (EU) 2017/746, notably in relation to their performance evaluation. It also makes a number of editorial corrections to existing specifications.
Notified Document
1:
File here
2:
File here
Link to Notification
EN:
File here
FR:
File here
ES:
File here
Status Active
Active
Inactive
Comment
No
#
Comment By
Title
Comment Date
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