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

© EAAR 2012Version 1, revised on 04.09.2012

Annual Report 2011


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


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


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

4


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


Organigram

6

Mr. Mika ReinikainenChairman(Abnovo, UK)

Mr. Ludger MoellerDeputy-Chairman(MDSS, DE)

Mr. Gideon ElkayamTreasurer(Obelis s.a., BE)

Officer General Manager

Mr. John L. WebsterSecretary(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)


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


Plenary

• EAAR Participants

Mr. Mika Reinikainen (Abnovo) & Mr. Ludger Möller (MDSS)

• Objectives

…

• Results / Current discussions

8


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


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



• Chair – EC

• EAAR Participants Mr. Jaap Laufer (EMDAR, b.v.) &

Mr. Mika Reinikainen (Abnovo)



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



• Chair – FR

• EAAR Participants Mr. Dirk Stynen (Qarad bva) & Mrs.

Sandra Ferretti (Obelis s.a.)



• 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)



Notified Bodies, COM services

• Chair

AT

• EAAR Participants Mr. Jeremy Tinkler & Mrs. Maria Donawa

(Donawa)

13


Clinical Investigation & Evaluation (CIE)


• 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



• Chair – EC

• EAAR Participants Mr. John Webster (Obelis s.a.) & Mrs.

Caroline Freeman (AR-Med)


Electronic Labeling


• 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



• Chair – PT

• EAAR Participants Mr. Mika Reinikainen (Abnovo) &

Mrs. Claire Murphy (Tecno-Med Ingenieros)


New & Emerging Technologies


• WG Scope To advice on all issues related to the

implementation of the Eudamed database.

16



• Chair – EC

• EAAR Participants Mrs. Sandra Ferretti (Obelis s.a.) &

Julia


Eudamed


• 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


• 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


NB-MED


European Commission Working Groups Meetings

19

1. Compliance & Enforcement WG-COEN 24.01.2012

2. Notified Body Operations Groups - NBOG 02.02.2012

3. Special MDEG Meeting “Revision MD Legislation” 13.02.2012

4. Special MDEG Meeting “Revision IVD Legislation” 17.02.2012

5. MD Classification & Borderline EG 20.02.2012

6. IVD Technical Group 21.02.2012

7. EUDAMED WG – Special Business Guide 21-22.03.2012

8. NB-Med (NBRG subgroup meeting on 1st day) 16-18.04.2012

9. Vigilance MDEG 24-25.04.2012


11. WG on Clinical Investigation & Evaluations 29.05.2012

12. MDEG Meeting 04.06.2012

13. Compliance and Enforcement WG - COEN 06.06.2012

14. Notified Body Operations Group NBOG 25.06.2012




18. WG Software 02.10.2012

19. WG on Clinical Investigation & Evaluation 03.10.2012

20. NB-MED (NBRG subgroup meeting on 1st day) 08-10.10.2012

21. Compliance & Enforcement WG - COEN 12.10.2012

22. WG New & Emerging Technology 18.10.2012

23. MDEG Vigilance 30-31.10.2012

24. Notified Body Operations Group - NBOG 08.11.2012

25. EUDAMED WG 14.11.2012

26. MDEG Meeting 13-14.12.2012


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


Activity expectations 2012

• To be completed by Mika

21


EAAR bank account showed a total of

12.809,05 €

On December 31st, 2011

22

Budget 2011


• Proposed membership fees 2012

• Objective – to finish 2012 with minimum 10.000 € in the bank account.

23

Number of Employees Annual Membership Fees

3 & less 360,00 €

4 – 9 420,00 €

10 – 29 590,00 €

30 – 59 830,00 €

60+ 1600,00 €

Budget 2012


24

Budget 2012

Expected 15 Membership fees for 201213 members2 candidates

Date2012

Amount per member300,00 €

Total income4.500,00 €Total account expected17.695,46 €

Educational events by EAAR DateDuring 2012

Amount per member Amount total

E.A.A.R. meetings DateDuring 2012

NumberNo more than 4 meetings

Amount per meetingNo more than 1.500,00 €

E.A.A.R. 10 year anniversary party

Date Amount +/- 4.000,00€

E.A.A.R. Website Amount1.625,00€ (excl. VAT)

Recuperating traveling cost according to Lobby program

AmountFlight/train tickets only

Recuperating traveling cost to EU Commission Working groups meetings

AmountFlight/train ticket only.

Amount expected to be paid in 2012not yet paid memberships

Amount4.500,00 €


Thank You

for Your Collaboration and Commitment as

EAAR Member !

Documents

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