LIST OF VIGILANCE CONTACT POINTS WITHIN THE COMPETENT AUTHORITIES (June 2001) MEDDEV 2.

12-1 rev 4 - APPENDIX 1

update : 23.07.2001 July 2001

COUNTRIES NAMES E-mail/ Web site ADDRESSES PHONE FAX

AUSTRIA AIMD Dr. W Ecker Abt. VIII/A/22- Medical Devices/Medizinprodukte +43 1 71100 4206 or 4487 +43 1 71100 4217
Radetzkystrasse 2 or 4492
Federal Ministry of MDD Dr. Renhardt or 43 1 715 73 12
A-1031 Vienna
Social Security and
Generations ng. Gutruf
BELGIUM AIMD Mr. P. Bauwin Vesalius Building – Rijksadministratief Centrum 32/2/210.63.58 32/2/210.49.01
The Ministry of Health, Mrs. Mignon B- 1010 Brussels
MDD
Pharmaceutical
Inspectorate, Medical IVD Dr. JL Libeer Jean-Claude.Libeer@ipf.fgov.be Institut Scientifique de la Santé Publique Louis Pasteur +32 2 642 55 27 +32 2 642 56 45
Devices Vigilance Rue Juliette Wytsman 14
meddev@health.fgov.be 1050 Bruxelles
DENMARK Mr H-K hka@dkma.dk Frederikssundsvej 378 +45/44/889.111 +45/44/889.195
Danish Medicines Andersen DK- 2700 Brønshøj +45/44/889.265 (direct line)
Agency
FINLAND IVD Mr Petri +358/9/4733-4249 +358/9/4733-4266
Medical Devices Centre MDD Pommelin Mannerheimintie 166 – PO Box 55
National Agency for AIMD FIN- 00301 Helsinki
Medicines IVD Dr Jarkko jarkko.ihalainen@nam.fi +358-9-4733 42 64
Ihalainen
MDD Mr Harry harry.sievanen@nam.fi +358-9-4733 41
AIMD Sievänen
FRANCE MDD Dr J-C Ghislain jean-claude.ghislain@afssaps.sante.fr AFSSAPS +33 1 55 87 37 47 +33 1 55 87 37 42
Agence Française de IVD 143 / 147 Boulevard Anatole France
http://afssaps.sante.fr F-93285 Saint - Denis Cedex
Sécurité Sanitaire des
Produits de Santé
AIMD Dr. E. Stößlein e.stoesslein@bfarm.de Geschäftsstelle Medizinprodukte (BfArM) +49/228/207.53.84 +49/228/207.53.00
GEMANY MDD Friedrich-Ebert-Allee 38 +49 228 207 53 60 +49 228 207 53 00
Bundesinstitut für D-53113 Bonn
Arzneimittel und Medizin- For certain products (most Annex II products): Paul-
produkte IVD Dr. R. Siekmeir r.siekmeir@bfarm.de Ehrlich-Institute (PEI) +49 6103 77 33 04 +49 6103 77 12 65
Paul-Ehrlich-Strasse 51-59
63225 Langen in Hessen
GREECE Services National Organization for Medicines +30/1/65 07 380 +30/1/65 49 585
Ministry of Health, Dr. G.P. 284 Messogion Avenue
Welfare and Social Demagos 15562 Holargos Attikis

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 IRELAND Ms. S. Phelan Hawkins House +353/1/675.41.77 +353/1/635.43.74
Department of Health Mr. A. Ryan alan_ryan@health.irlgov.ie IRL-Dublin 2 +353/1/675.41.78
and Children IVD Ms Ann Irish Competent Authority for IVD's
O'Connor
ICELAND Mrs. Vilborg vilborg@landlaeknir Laugavegur 116 +35/45/609.700 +35/45/519.165
Ministry of Health and Ingolfsdottir IS- 150 Reykjavik
Social Service
Dottissa M. Department II - P. le Industria 20 +39/6/5994.2423 +39/6/5994.2111
ITALY Marletta I-00144 ROMA
Ministry of Health IVD Dr.ssa Mirella Dipartimento per la Valutazione dei Medicinalie la +39 06 59 94 37 22 +39 6 59 94 32 85
Colella Farmacovigilanza Ufficio IX,
Via della Civilta’Romana,7
I-00144 Roma
LUXEMBOURG Dr. G Scharll gerard.scharll@ms.etat.lu Villa Louvigny - Allée Marconi +352/478.56.34 +352/262.03.296
Ministère de la Santé L-2120 Luxembourg
Direction de la Santé
NETHERLANDS IVD Mr. J. Moleveld medtech.higz@igz.nl Cluster Medical Technology +31/70/340.74.36 +31/70/340.71.59
MDD PO Box 16119
Health Care Inspectorate
NL-2500 BC Den Haag
Mrs. I Hagerup ingeborg.hagerup- PO Box 8128 Dep. + 47/22/24.89.53 + 47/22/249.017
NORWAY jenssen@helsetilsynet.dep.telemax.no N- 0032 Oslo +47/22/24.89.40
National Board of Health Mrs. Tove tove.farstad@helsetilsynet.dep.no Medical Device Unit +47-22 24 89 42 +47-22 24 90 17
Farstad Calmeyersgate 1 +47-22 24 89 88
http://www.helsetilsynet.no/ PoB 8128 Dep.
N - 032 OSLO
PORTUGAL Dr. H.M. Ribeiro Heitor.Costa@infarmed.pt Parque de Saúde de Lisboa; +351/21/798 71 79 +351/21/798 71 55
MDD Costa adriana.gamboa@infarmed.pt Av. do Brasil, 53 +351/21/798 71 51
Centro Nacional de
IVD bruno.gama@infarmed.pt P-1749 - 004 Lisboa +351/21/798 71 45
Farmacogivilância do
INFARMED Mr Faria-Gomes Av. Padre Cruz +351/1/757.35.57 +351/1/757.36.71
AIMD P-1699 Lisboa Codex

SPAIN Mrs. C. Abad cabad@msc.es + cvalls@ms.es Dirección General de Farmacia y Productos Sanitarios +34/91/596.43.48 +34/91/ 596 44 00
Ministerio de Sanidad y Luna Paseo del Prado 18/20
Consumo Mrs. C. Valls E-28014 Madrid

SWEDEN Dr M Soop michael.soop@sos.se Division of Medical Devices +46/8/55.55.33.28 +46/8/55.55.32.94

The National Board of S- 106 30 Stockholm
Health and Welfare Mr Lars lars.I.johansson@sos.se SOCIALSTYRELSEN 08-5555 530 00 +46-8-555 532 94
Johansson www.sos.se visit Rålambsvägen 3 +46-8-555 530 00
Mail SE-106 30 STOCKHOLM dir.+46-8-555-532 16

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 SWITZERLAND Mr A Sparti sfoph.md@bag.admin.ch Medical Devices Unit, Vigilance +41/31/322.98.03 +41/31/322.76.46
Office fédéral de la Santé CH-3003 Bern +41 31 323 22 51
Publique
UNITED KINGDOM Mr A. Sant mb-mda-aic@doh.gsi.gov.uk Adverse Incident Center +44/171/972.80.80 +44/171/972.81.09
Medical Devices Agency Hannibal House, Elephant and Castle
UK-London SE1 6TQ