Corrigendum for the MDR published

The EUROPEAN COMMISSION published the first Corrigendum for the Medical Device Regulation (EU) 2017/745.

 

The document includes 125 pages with corrections necessary in each of the official languages of the EU.

 

The various translations include a different number of corrections:

 

  • Languages with 10 corrections:   CS, DE, LT,PL, FI
  • Languages with 11 corrections:   BG, DA, ET, EL, FR, GA, HR, IT, LV, HU, MT, NL, PT, RO, SK, SL, SV
  • Languages with 14 corrections:   EN

 

 

The German Version of the document corrects the following 10 items:

  • Art. 10, 15
  • Art. 74,1
  • Art. 78,14
  • Art. 120, 10
  • Annex VII, 4.5.2 a
  • Annex VIII, 3.2
  • Annex IX, 2.3 (3)
  • Annex IX, 3
  • Annex IX, 3.5 (1)
  • Annex IX 4.3

The english version further corrects 

  • Art.2,30           - a typo for "trade mark"
  • Art. 7               - a typo for "trade marks"
  • Art. 120,6        - "prior to 26 May"
  • Annex XV,2.5  - undesirable side-effects,

 

The details and the corrected wording can be found here.

 

UPDATE:

A consolidated version is published by the Commission (as not legal binding version).