© EAAR 2012 Version 1, revised on Annual Report 2011

© EAAR 2012 Version 1, revised on Presentation Structure Who are we? Facts & Figures Mission statement Organigram. Members European Commission working groups participation European Commission working groups activity European Commission working groups meetings Activity conclusions Budget Activity plans Budget 2

© EAAR 2012 Version 1, revised on Who are we? The European Association of Authorised Representatives (EAAR) is an alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence among the Authorised Representative profession. 3

© EAAR 2012 Version 1, revised on Facts & Figures Created in members 2 annual meetings 8 EU Member States represented Actively participating in 9 EU Working Groups Contact information  4

© EAAR 2012 Version 1, revised on Mission Statement To provide an understanding of the European Authorised Representatives’ responsibilities to the other stakeholders. To promote compliance of the medical devices falling the legislative texts requiring an European Authorised Representative 5

© EAAR 2012 Version 1, revised on Organigram 6 Mr. Mika Reinikainen Chairman (Abnovo, UK) Mr. Ludger Moeller Deputy-Chairman (MDSS, DE) Mr. Gideon Elkayam Treasurer (Obelis s.a., BE) Officer General Manager Mr. John L. Webster Secretary (Obelis s.a., BE) Members 1. AbNovo Ltd. – UK (Mr. Mika Reinikainen) 7. MedPass International – FR (Mrs. Sarah Sorrel) 2. Advena Ltd. – UK (Mr. John Adcock) 8. MT Promedt Consulting – DE (Mr. Michael Rinck) 3. AR-Med – UK (Mrs. Caroline Freeman) 9. Obelis s.a. – BE (Mr. Gideon Elkayam, Mr. John L. Webster, Mrs. Sandra Ferretti) 4. Donawa Lifescience Consulting s.r.l. – IT (Mrs. Maria Donawa) 10. Qarad b.v.b.a. – BE (Mr. Dirk Stynen) 5. Emergo Europe – USA (Mrs. Evangeline Loh) 11. Q-Med Consulting ApS – DK (Mrs. Helene Quie) 6. Medical Device Safety Service GmbH – DE (Mr. Ludger Moeller) 12. Tecno-Med Ingenieros – ES (Mrs. Claire Murphy)

© EAAR 2012 Version 1, revised on European Commission Working Groups Activity To be completed by Mika with the general purpose and goals of EAAR participation in the EC Working Groups 7

© EAAR 2012 Version 1, revised on Plenary EAAR Participants  Mr. Mika Reinikainen (Abnovo) & Mr. Ludger Möller (MDSS) Objectives  … Results / Current discussions 8

© EAAR 2012 Version 1, revised on Vigilance Participants  Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services Chair – EC EAAR Participants  Mr. Ludger Möller (MDSS) & Mrs. Sandra Ferretti (Obelis s.a.) Results / Current discussions  ….? WG Scope  Issues concerning adverse event reporting. Description  The forum where all interested parties exchange guidance, information, discuss actual adverse event cases, review current reporting practices and prepare input into the Eudamed database. The Vigilance group also acts as the GHTF- Study Group 2 "Mirror Group". 9

© EAAR 2012 Version 1, revised on Classification & Borderline WG Scope  To discuss questions of o Borderline: Is a given product a medical device or something else (i.e. medicine, cosmetic, biocide). o Classification: Matters concerning in which class a given medical device or medical device group needs to fall are discussed. Description  The group typically uses an 'Enquiry Template' to communicate questions to all Member States and gather responses. Responses are collated and presented at the meeting by the Member State originator, including their proposed consensus opinion based on the responses 10 Participants  Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services Chair – EC EAAR Participants  Mr. Jaap Laufer (EMDAR, b.v.) & Mr. Mika Reinikainen (Abnovo) Results / Current discussions  ….?

© EAAR 2012 Version 1, revised on IVD Technical Group WG Scope  To supply the Commission, MDEG and other Working Groups with technical and specific input, for example by the drafting of CTS and examination of other specific or general issues, to aid in the uniform interpretation and implementation of the IVD Directive. 11 Participants  Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services Chair – FR EAAR Participants  Mr. Dirk Stynen (Qarad bva) & Mrs. Sandra Ferretti (Obelis s.a.) Results / Current discussions  ….?

© EAAR 2012 Version 1, revised on WG Scope  To develop and promote homogenous interpretation and implementation of European Medical Device Directives with regard to clinical evaluation and investigation, incl. PMCF, and to enhance related cooperation between MS's.  To explore whether Medical Device legislation on clinical evidence is appropriate/adequate/sufficient, to advice on eventual further development and to consider the need for/develop guidance on specific issues. 12  To serve as European Mirror Group for GHTF SG 5.  To monitor the relevant EU and international regulatory/normative environment and European/ISO Standardisation in the clinical area.  To support the Strategic Development of the sector in the clinicals.  To act as a forum for information on clinical investigations. Clinical Investigation & Evaluation (CIE)

© EAAR 2012 Version 1, revised on Participants  Competent Authorities (experts), Industry, Notified Bodies, COM services Chair  AT EAAR Participants  Mr. Jeremy Tinkler & Mrs. Maria Donawa (Donawa) 13 Results / Current discussions  ….? Clinical Investigation & Evaluation (CIE)

© EAAR 2012 Version 1, revised on WG Scope  To consider and prepare guidance on the circumstances and manner in which the Instructions For Use (IFU) and other information required for the safe and proper use of medical devices can be provided, including any limitations and safeguards that should be applied. Such guidance will form the basis for possible Community measures on e-labelling. 14 Participants  Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services Chair – EC EAAR Participants  Mr. John Webster (Obelis s.a.) & Mrs. Caroline Freeman (AR-Med) Results / Current discussions  ….? Electronic Labeling

© EAAR 2012 Version 1, revised on WG Scope  Identify new and emerging technologies in the area of medical devices.  Consider the adequacy of the existing devices regulatory regime in relation to those technologies. Where shortcomings are identified make recommendations to the Medical Device Expert Group to solve them by either the production of guidance or regulatory change.  Comment on relevant issues in connection to new and emerging technologies in other areas, as far as it affects medical devices 15 Participants  Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services Chair – PT EAAR Participants  Mr. Mika Reinikainen (Abnovo) & Mrs. Claire Murphy (Tecno-Med Ingenieros) Results / Current discussions  ….? New & Emerging Technologies

© EAAR 2012 Version 1, revised on WG Scope  To advice on all issues related to the implementation of the Eudamed database. 16 Participants  Competent Authorities (experts), Industry, Notified Bodies, Standardisation Bodies, COM services Chair – EC EAAR Participants  Mrs. Sandra Ferretti (Obelis s.a.) & Julia Results / Current discussions  ….? Eudamed

© EAAR 2012 Version 1, revised on WG Scope  To share experience and exchange views on application of conformity assessment procedures with the aim of contributing to a better understanding and consistent application of requirements and procedures.  To draft technical recommendations on matters relating to conformity assessment and build a consensus.  To advise the Commission, at its request, on subjects related to application of the medical device directives. 17  To consider, and if necessary, draft reports on ethical aspects of notified bodie's activities.  To ensure consistency with standardization work at European level.  To keep informed o harmonisation activities at European level. NB-MED

© EAAR 2012 Version 1, revised on Participants  Notified Bodies, Competent Authorities (experts), Industry, Standardisation Bodies, COM services Chair  Notified Bodies (NL) EAAR Participants  Mrs. Sandra Ferretti (Obelis s.a.) & Mr. Roger Gray 18 Results / Current discussions  ….? NB-MED

© EAAR 2012 Version 1, revised on European Commission Working Groups Meetings 19 1.Compliance & Enforcement WG-COEN Notified Body Operations Groups - NBOG Special MDEG Meeting “Revision MD Legislation” Special MDEG Meeting “Revision IVD Legislation” MD Classification & Borderline EG IVD Technical Group EUDAMED WG – Special Business Guide NB-Med (NBRG subgroup meeting on 1st day) Vigilance MDEG MD Classification & Borderline EG WG on Clinical Investigation & Evaluations MDEG Meeting Compliance and Enforcement WG - COEN Notified Body Operations Group NBOG IVD Technical Group IVD Technical Group MD Classification & Borderline EG WG Software WG on Clinical Investigation & Evaluation NB-MED (NBRG subgroup meeting on 1st day) Compliance & Enforcement WG - COEN WG New & Emerging Technology MDEG Vigilance Notified Body Operations Group - NBOG EUDAMED WG MDEG Meeting

© EAAR 2012 Version 1, revised on Activity conclusions 2011 To be completed with information from Mika  Until 2011 o EAAR overview activity o EAAR achievements  2011 o EAAR overview activity o EAAR achievements 20

© EAAR 2012 Version 1, revised on Activity expectations 2012 To be completed by Mika 21

© EAAR 2012 Version 1, revised on EAAR bank account showed a total of ,05 € On December 31 st, Budget 2011

© EAAR 2012 Version 1, revised on Proposed membership fees 2012 Objective – to finish 2012 with minimum € in the bank account. 23 Number of EmployeesAnnual Membership Fees 3 & less360,00 € 4 – 9420,00 € 10 – 29590,00 € 30 – 59830,00 € ,00 € Budget 2012

© EAAR 2012 Version 1, revised on Budget 2012 Expected 15 Membership fees for 2012  13 members  2 candidates Date 2012 Amount per member 300,00 € Total income 4.500,00 € Total account expected ,46 € Educational events by EAAR Date During 2012 Amount per memberAmount total E.A.A.R. meetings Date During 2012 Number No more than 4 meetings Amount per meeting No more than 1.500,00 € E.A.A.R. 10 year anniversary party Date Amount +/ ,00€ E.A.A.R. Website Amount 1.625,00€ (excl. VAT) Recuperating traveling cost according to Lobby program Amount Flight/train tickets only Recuperating traveling cost to EU Commission Working groups meetings Amount Flight/train ticket only. Amount expected to be paid in 2012 not yet paid memberships Amount 4.500,00 €

© EAAR 2012 Version 1, revised on Thank You for Your Collaboration and Commitment as EAAR Member !