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.
A consolidated version is currently missing....