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

28 th CAMD Krakow Session 5 COEN 2 COEN October 2011 Meetings: – 5 th May 2011(18 MS + COM) – 7 th October 2011(19 MS + COM) The meetings focused on – Information to the group: E.g. on the recast, new methods for market surveillance (sharing work load) – Cooperation with custom authorities – Guides for market surveillance, authorised representatives, re- sterilisation of medical devices, assessment of the technical file for IVF and ART – Roles and responsibilities of the economic actors – Specific MS projects and activities

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 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 has come to 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 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 Work Programme status Guide for Authorised representatives – A revised document was discussed and approved by COEN 7 th October. – The document has been sent for comments to EAAR – Proposal: CAMD endorse this document 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 Work Programme status Guide for conformity assessment of In-Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products – A document has been developed by an ad hoc group set up by FR, PT, SE – The document was presented to MDEG at the June meeting with an invitation to send in comments to FR (the ad hoc group)

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 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 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

28 th CAMD Krakow Session 5 COEN 12 New Work Programme for Continuation of work programme from 2011 Main focus – To carry on the work with development of the decided guide documents, – Market surveillance projects, – Follow up the legal development and the impact on market surveillance, – Follow and Co-ordinate actions based on national projects and experiences

28 th CAMD Krakow Session 5 COEN 13 Next Meeting 26 January 2012 (tentative) Agenda to be prepared