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© EAAR 2012 Version 1, revised on 04.09.2012 Annual Report 2011.

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Presentation on theme: "© EAAR 2012 Version 1, revised on 04.09.2012 Annual Report 2011."— Presentation transcript:

1 © EAAR 2012 Version 1, revised on 04.09.2012 Annual Report 2011

2 © EAAR 2012 Version 1, revised on 04.09.2012 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 2011. Budget Activity plans 2012. Budget 2

3 © EAAR 2012 Version 1, revised on 04.09.2012 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

4 © EAAR 2012 Version 1, revised on 04.09.2012 Facts & Figures Created in 2002 12 members 2 annual meetings 8 EU Member States represented Actively participating in 9 EU Working Groups Contact information  www.eaarmed.org www.eaarmed.org 4

5 © EAAR 2012 Version 1, revised on 04.09.2012 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

6 © EAAR 2012 Version 1, revised on 04.09.2012 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)

7 © EAAR 2012 Version 1, revised on 04.09.2012 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

8 © EAAR 2012 Version 1, revised on 04.09.2012 Plenary EAAR Participants  Mr. Mika Reinikainen (Abnovo) & Mr. Ludger Möller (MDSS) Objectives  … Results / Current discussions 8

9 © EAAR 2012 Version 1, revised on 04.09.2012 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

10 © EAAR 2012 Version 1, revised on 04.09.2012 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  ….?

11 © EAAR 2012 Version 1, revised on 04.09.2012 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  ….?

12 © EAAR 2012 Version 1, revised on 04.09.2012 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)

13 © EAAR 2012 Version 1, revised on 04.09.2012 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)

14 © EAAR 2012 Version 1, revised on 04.09.2012 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

15 © EAAR 2012 Version 1, revised on 04.09.2012 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

16 © EAAR 2012 Version 1, revised on 04.09.2012 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

17 © EAAR 2012 Version 1, revised on 04.09.2012 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

18 © EAAR 2012 Version 1, revised on 04.09.2012 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

19 © EAAR 2012 Version 1, revised on 04.09.2012 European Commission Working Groups Meetings 19 1.Compliance & Enforcement WG-COEN24.01.2012 2.Notified Body Operations Groups - NBOG02.02.2012 3.Special MDEG Meeting “Revision MD Legislation”13.02.2012 4.Special MDEG Meeting “Revision IVD Legislation”17.02.2012 5.MD Classification & Borderline EG20.02.2012 6.IVD Technical Group21.02.2012 7.EUDAMED WG – Special Business Guide21-22.03.2012 8.NB-Med (NBRG subgroup meeting on 1st day)16-18.04.2012 9.Vigilance MDEG24-25.04.2012 10.MD Classification & Borderline EG02.05.2012 11.WG on Clinical Investigation & Evaluations29.05.2012 12.MDEG Meeting04.06.2012 13.Compliance and Enforcement WG - COEN06.06.2012 14.Notified Body Operations Group NBOG25.06.2012 15.IVD Technical Group27.05.2012 16.IVD Technical Group12.09.2012 17.MD Classification & Borderline EG01.10.2012 18.WG Software02.10.2012 19.WG on Clinical Investigation & Evaluation03.10.2012 20.NB-MED (NBRG subgroup meeting on 1st day)08-10.10.2012 21.Compliance & Enforcement WG - COEN12.10.2012 22.WG New & Emerging Technology18.10.2012 23.MDEG Vigilance30-31.10.2012 24.Notified Body Operations Group - NBOG08.11.2012 25.EUDAMED WG14.11.2012 26.MDEG Meeting13-14.12.2012

20 © EAAR 2012 Version 1, revised on 04.09.2012 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

21 © EAAR 2012 Version 1, revised on 04.09.2012 Activity expectations 2012 To be completed by Mika 21

22 © EAAR 2012 Version 1, revised on 04.09.2012 EAAR bank account showed a total of 12.809,05 € On December 31 st, 2011 22 Budget 2011

23 © EAAR 2012 Version 1, revised on 04.09.2012 Proposed membership fees 2012 Objective – to finish 2012 with minimum 10.000 € in the bank account. 23 Number of EmployeesAnnual Membership Fees 3 & less360,00 € 4 – 9420,00 € 10 – 29590,00 € 30 – 59830,00 € 60+1600,00 € Budget 2012

24 © EAAR 2012 Version 1, revised on 04.09.2012 24 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 17.695,46 € 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 +/- 4.000,00€ 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 €

25 © EAAR 2012 Version 1, revised on 04.09.2012 Thank You for Your Collaboration and Commitment as EAAR Member !

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