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 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

Council of the
                  European Union
                                                            Brussels, 24 February 2017
                                                            (OR. en)
                                                            10728/16
       Interinstitutional File:                             COR 1
           2012/0266 (COD)
                                                            PHARM 43
                                                            SAN 284
                                                            MI 478
                                                            COMPET 402
                                                            CODEC 977
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 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
On page 127, in Article 29(3):
For:
"3.      For devices that are the subject of a conformity assessment as referred to in the second
         sentence of Article 52(3), or the third subparagraph of Article 52(4), the assignment of a
         Basic UDI-DI…"
read:
"3.      For devices that are the subject of a conformity assessment as referred to in Article 52(3)
         and in the second and third subparagraphs of Article 52(4), the assignment of a
         Basic UDI-DI…".
10728/16 COR 1                                                            AV/jk
                                                DGB 2C                                           EN