Published
Amendments are given in clauses 2 and 9.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
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
HarmonizedRegulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Harmonized
                    PUBLISHED
                    SRPS EN ISO 11137-2:2016/A1:2023
                    60.60
                                        Standard published
                    Aug 31, 2023
                
                PROJECT
                                    prSRPS EN ISO 11137-2:2024