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Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices
Text
Chronology
Context
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Basic information
In force
CELEX number:
32021R2226
Official Journal:
JOL_2021_448_R_0005
Form:
Regulation
Procedure number:
--
Languages:
bg
cs
da
de
el
en
et
fi
fr
ga
hr
hu
it
lv
lt
mt
nl
pl
pt
ro
sk
sl
es
sv
Dates
Date of document:
December 14, 2021
Date of publication:
December 15, 2021
Date of effect:
January 4, 2022
Entry into force - Date pub. +20 See Art 11
Modified by
Modifies
Repeal:
Règlement (UE) n ° 207/2012 de la Commission du 9 mars 2012 relatif aux instructions d’emploi électroniques des dispositifs médicaux Texte présentant de l'intérêt pour l'EEE
Affected by case
Legal basis
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )
EuroVoc Vocabulary
Quality standard
Electronic document
Market approval
EC conformity marking
Harmonisation of standards
Consumer information, education and representation
Safety standard
Medical devices
Consumer information
User guide
Public health
Labelling
Internal market - Principles
Medical device
Protection of health and safety