Annual Report 2011

1. Annual Report 2011

2. 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

3. 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.

4. 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

5. 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

6. Organigram Mr. Mika Reinikainen Chairman (Abnovo, UK) Mr. Ludger Moeller Deputy-Chairman (MDSS, DE) Officer Mr. John L. Webster Secretary (Obelis s.a., BE) Mr. Gideon Elkayam Treasurer (Obelis s.a., BE) General Manager

7. European Commission Working Groups Activity To be completed by Mika with the general purpose and goals of EAAR participation in the EC Working Groups

8. Plenary • EAAR Participants • Mr. Mika Reinikainen (Abnovo) & Mr. Ludger Möller (MDSS) • Objectives • … • Results / Current discussions

9. 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".

10. Classification & Borderline • WG Scope • To discuss questions of • Borderline: Is a given product a medical device or something else (i.e. medicine, cosmetic, biocide). • 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 • 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. 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. • 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. Clinical Investigation & Evaluation (CIE) • 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. • 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.

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

14. Electronic Labeling • 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 • ….? • 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.

15. New & Emerging Technologies • 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 • ….? • 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

16. Eudamed • 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 • ….? • WG Scope • To advice on all issues related to the implementation of the Eudamed database.

17. NB-MED • 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. • 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.

18. NB-MED • Results / Current discussions • ….? • 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

19. European Commission Working Groups Meetings

20. Activity conclusions 2011 • To be completed with information from Mika • Until 2011 • EAAR overview activity • EAAR achievements • 2011 • EAAR overview activity • EAAR achievements

21. Activity expectations 2012 To be completed by Mika

22. Budget 2011 EAAR bank account showed a total of 12.809,05 € On December 31st, 2011

23. Budget 2012 Proposed membership fees 2012 Objective – to finish 2012 with minimum 10.000 € in the bank account.

24. Budget 2012

25. Thank You for Your Collaboration and Commitment as EAAR Member !