Report from COEN CAMD Krakow 27 – 28 October 2011 Lars Johansson

28 th CAMD Krakow Session 5 COEN Election of a new Chair and Co-Chair You are all invited to nominate candidates to the positions as Chair and Co-chairof COEN We would like to have your nomination before the end of January The appointments will take place at the CAMD in DK

28 th CAMD Krakow Session 5 COEN 3 COEN October 2011 Meetings: – 5 th May 2011(18 MS + COM) – 7 th October 2011(19 MS + COM) From those figures it is obvious that there are to many countries that does not take an active part in the work of COEN.

28 th CAMD Krakow Session 5 COEN Work Programme status Guide for Authorised representatives – A revised document was discussed and approved by COEN 7 th October. – After that EAAR has expressed their support for this document – Proposal: CAMD endorse the guide for further processing (MDEG + publication at COM Webb- page)

28 th CAMD Krakow Session 5 COEN Work Programme status Guide for conformity assessment of IVF and ART products – A document has been developed by an ad hoc group set up by FR, PT, SE – The document was approved by COEN in May and it was presented to MDEG in June (invitation to industry to send in comments during summer) Proposal: CAMD endorse the guide for further processing (MDEG + publication at COM Webb- page)

28 th CAMD Krakow Session 5 COEN Work Programme status FAQ - Guide for market surveillance – For the time being we are focusing 67 questions – 39 questions are closed by COEN (6 in cooperation with NBOG) – A compiled list is included in the documentation (clarifications and statements to improve a harmonised implementation). – We ask you all to study those questions and to make use of the answers given.

28 th CAMD Krakow Session 5 COEN Economic operators This issue was discussed during the preparation of 2007/47. After discussion in MSOG (2006) the presidency presented a document that was agreed by MS. The present discussions in COEN are based on 768/2008 and the document from The draft document being circulated to this meeting is the result from two discussion held in COEN (May and Oct). – My impression is that we reached a point where we accept the basic structure of the document and also the majority of the more detailed points. Proposal: The document will be sent to the Recast WG and COM. COEN shall follow the progress of this matter

28 th CAMD Krakow Session 5 COEN Work Programme status IFU for cleaning and re-sterilisation of reusable medical devices – An ad-hoc group is established with members from DE, ES, IE, CH and PT – Work is carried out and a document is announced for the next meeting with COEN

28 th CAMD Krakow Session 5 COEN Addresses 7th June 2011 CMC issued a decision to harmonise the interpretation on what address shall be presented on a MD placed on the market. COEN was asked to appropriately enforce the implementation of this decision. – At the meeting in May it was decided to give manufac- turers a transitional period of one year (1 st September 2012) – A letter from COEN to European branch organisations, notified bodies and WG’s (6 th July) – NCA to inform national MF/AR and other stakeholders Follow up 7 th October: 

28 th CAMD Krakow Session 5 COEN Cooperation with customs authorities TAXUD has launched a project to develop guidelines to improve cooperation between market surveillance authorities and customs. 10 MS has formed a WG and we expect to have a first set of guiding documents in 2012 (an umbrella combined with an information sheet and a checklist describing the different sectors) A proposal set up by COM has been discussed in detail and it will be presented to TAXUD.

28 th CAMD Krakow Session 5 COEN Work program for 2012 COEN is in reality over loaded Difficult to develop and finalise the individual items in due time. - Difficult to have two masters WI:s to be closed/halted Put the development of new answers to FAQ on hold Close the WI on the development of a Guide for Authorised Representatives Close the WI on IVF/ART

28 th CAMD Krakow Session 5 COEN Proposals for new work items CMC has asked COEN to provide – A guide specifying the content of the Declaration of conformity. PL, NL, DK, PT, BE-IVD, FR – Unduly CE market medical devices (Main issue to clarify when we may grant a period of grace) FI – Step by step guide to market surveillance SE Proposal: CAMD endorses the inclusion of the two NWI.

28 th CAMD Krakow Session 5 COEN 13 New Work Programme for Continuation of work programme from 2011 Main focus – To carry on the work with development of the decided guide documents, – To identify and coordinate Market surveillance projects, – Follow the legal development and the impact it will have on market surveillance, – Follow and Co-ordinate actions based on national projects and experiences

28 th CAMD Krakow Session 5 COEN 14 Thank You