CELEX: 
Language: en
Date: 2017-02-24
Title: Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Council of the
                   European Union
                                                            Brussels, 24 February 2017
                                                            (OR. en)
                                                            10729/16
       Interinstitutional File:                             COR 1
          2012/0267 (COD)
                                                            PHARM 44
                                                            SAN 285
                                                            MI 479
                                                            COMPET 403
                                                            CODEC 978
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:             Position of the Council at first reading with a view to the adoption of a
                     REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
                     COUNCIL on in vitro diagnostic medical devices and repealing
                     Directive 98/79/EC and Commission Decision 2010/227/EU
On page 100, in Article 26(2):
For:
"2.      For devices that are the subject of a conformity assessment as referred to in Article 48(4)
         and 48(8), the assignment of a Basic UDI-DI…",
read:
"2.      For devices that are the subject of a conformity assessment as referred to in Article 48(3)
         and (4), the second subparagraph of Article 48(7), Article 48(8) and the second
         subparagraph of Article 48(9), the assignment of a Basic UDI-DI...".
10729/16 COR 1                                                            AV/sr
                                                DGB 2C                                           EN