The draft Commission Implementing Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council was open for public feedback until 25 October 2017.
On 10 November 2017 the Committee on Medical Devices favourably voted on the above draft Implementing Regulation. It has been adopted on 23 November 2017 and published as Commission Implementing Regulation (EU) 2017/2185 in the Official Journal L 309/7 on 24 November 2017.
On the Commission’s website – section “Implementing measures for Regulations” – you will find this and additional information, e.g. a note on scheduling of joint assessments.
Title | Publication |
Prague Resolution on recast of medical devices directives | Jul 2009 |
Prague Resolution on counterfeit medical devices | Jul 2009 |
Brdo Resolution | Feb 2008 |
Bonn Resoultion | Feb 2007 |
Vienna Resolution | Apr 2006 |