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

2. 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 2012. The appointments will take place at the CAMD in DK

3. 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.

4. 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)

5. 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)

6. 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.

7. 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 2006. 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

8. 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

9. 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: 

10. 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.

11. 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

12. 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.

13. 28 th CAMD Krakow Session 5 COEN 13 New Work Programme for 2011 - 2012 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

14. 28 th CAMD Krakow Session 5 COEN 14 Thank You