MEDICAL DEVICE VIGILANCE CONTACT POINTS WITHIN THE NATIONAL COMPETENT AUTHORITIES

Belgie / Belgique / Belgium

MDD AIMDD
Head of Unit : Th. Roisin, C. Duerink
Federal Public Service, Health, Food Chain Safety and Environment,
Directorate General Public Health Protection, Medicinal Products Medical Devices Unit
Place Victor Horta 40, boîte 40, B - 1060, Brussels,

tel:+32 2 524 8113 fax:+32 2 524 8120
E-mail: meddev@fagg.be - Web site - Web site

IVDMD
Dr. Anne Van Nerom, Latifa El Bali
Scientific Institute Public Health, Department of Clinical Biology
J. Wytsmanstraat, 14, B-1050 Brussels,

tel:+32 2 642 5392, fax:+32 2 642 5645
E-mail: Anne.VanNerom@wiv-isp.be, Latifa.ElBali@wiv.isp.be - Web site

Bulgaria

Head of Department: Dr. Lyubomir Dimitrov, Rumena Kamburova, Todor Darakchiev
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia,

tel:+359 2 890 3511, fax:+359 2 890 3434
E-mail: lyubomir.dimitrov@bda.bg, roumena.kambourova@bda.bg, darakchiev@bda.bg - Web site

Ceska Republika / Czech Republic

Irena Víchová
State Institute for Drug Control
Šrobárova 48, 100 41 Prague 10, Czech Republic,

tel: +420 272 185705, fax: +420 272 185764
E-mail: irena.vichova@sukl.cz Web site

Danmark / Denmark

Danish Medicines Agency
Axel Heides Gade 1, DK - 2300 - Kobenhavn, tel:+45 44 88 9595, fax:+45 44 88 9599
E-mail: med-udstyr@dkma.dk,

Web sites: www.medicinskudstyr.dk, www.medicaldevices.dk

Deutschland / Germany

AIMDD, MDD - Dr. Ekkehard Stößlein - tel:+49 228 207 5384
IVDMD - Prof. Dr. Rüdiger Siekmeier - tel:+49 228 207 5360
Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3, D - 53175 Bonn, fax:+49 228 207 5300
E-mail: medizinprodukte@bfarm.de - Web site

IVDMD
Dr. Markus Funk - tel:+49 6103 77 3115 Jochen Halbauer - tel:+49 6103 +77 3114
Paul Ehrlich Institute, Section Pharmacovigilance 2
Paul-Ehrlich-Strasse 51-59, D - 63225 Langen, fax:+49 6103 77 1268
E-mail: pharmacovigilance2@pei.de - Web site

Eesti / Estonia

Rainer Vabamäe - tel:+372 744 7409, fax:+372 744 7408
Health Board, Medical Devices Department
1a Põllu st., EE - Tartu 50303
E-mail: MSO@terviseamet.ee - Web site

Ireland / Eire

Andrea Hanson, Anne Tobin - tel:+353 1 676 4971, fax:+353 1 634 4033
Irish Medicines Board, Medical Devices Department
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: vigilance@imb.ie - Web site

Ellada / Greece

Dr. Dimintris Panidis - tel:+30 210 65 07 528, fax:+30 210 65 07585
Lia Goura - tel:+30 210 65 07 429 , fax:+30 210 65 07591
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens
E-mail: vigilancematerial@eof.gr, market-surveillance@eof.gr Web site

España / Spain

Carmen Abad
Carmen Valls - tel: +34 91 822 5255, fax: +34 91 822 5289
Ministerio Sanidad y Consumo Agencia Espaňola de Medicamentos y Productos Sanitarios
Parque Empresarial Las Mercedes, Edificio 8. C/ Campezo 1,

ES - 28022 Madrid
E-mail: psvigilancia@aemps.es - Web site

France

Sandrine Colas - tel:+33 1 558 73706 fax:+33 1 558 73702
Agence française de sécurité sanitaire des produits de santé (AFSSAPS)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mail: dedim.ugsv@afssaps.sante.fr - Web site

Italia / Italy

Head of Unit 3 - Dr. MonicaCapasso - tel:+39 06 5994 3063, fax:+39 06 5994 3812
Head of Unit 4 - Dr. Giovanna Nisticò - tel:+39 06 5994 3809, fax:+39 06 5994 3266
Ministry of Labour, Health and Social Affairs, Department of Innovation, Directorate General of Medicine and Medical Devices
via Giorgio Ribotta 5, IT - 00144 Roma
E-mail: m.capasso@sanita.it, g.nistico@sanita.it Web site

Kypros / Kibris / Cyprus

Stelios Christofides - tel:+357 22 605572
Andrie Stylianou - tel:+357 22 605574
Cyprus Medical Devices Competent Authority
Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia, fax:+357 22 468427
E-mail: cymda@mphs.moh.gov.cy Web site

Latvija / Latvia

Daiga Lagzdina - Nellija Kangare - tel:+371 670 78466
State Agency of Medicines, Medical Devices Evaluation Department
15 Jersikas street, LV - 1003 Riga
E-mail: daiga.lagzdina@zva.gov.lv, Nellija.Kangare@zva.gov.lv Web site

Lietuva / Lithuania

Jolanta Karavackaite, Julius Tertelis - tel:+370 5 261 5177, fax:+370 5 212 7310
The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
Zalgirio str. 92, LT- 09303 Vilnius
E-mail: julius.tertelis@vaspvt.gov.lt, jolanta.karavackaite@vaspvt.gov.lt, vaspvt@vaspvt.gov.lt - Web site Web site2

Luxembourg

Dr Gérard Scharll - tel:+352 478 5634, fax:+352 26 20 3296
Ministère de la Santé, Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: gerard.scharll@ms.etat.lu - Web site

Malta

Tristan Camilleri, David Pulis - tel:+356 21242000, fax:+356 21242406
Consumer and Industrial Goods Directorate Malta Standards Authority
2nd Floor Evans Building, Merchants Street, MT - Valletta VLT 03
E-mail: david.pulis@msa.org.mt, tristan-charles.camilleri@msa.org.mt, Web site

Magyarorzag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Authority for Medical Devices Budapest,
Arany J. u. 6-8.,Budapest, H-1051 Hungary
E-mail: vigilance@eekh.hu Web site

Nederland / Netherlands

Jan Moleveld, Laura de Vries - tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Healthcare Inspectorate
Postal address: P.O. Box 2680, NL - 3500 BS Utrecht, Visitors address: St. Jacobstraat 16, NL - 3511 BS Utrecht
E-mail: loket@igz.nl - Web site

Österreich / Austria

RonaldBauer - tel:+43 50 555 36450
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Institut Inspektionen, Medizinprodukte und Hämovigilanz - AGES PharmMed
Schnirchgasse 9, A-1030 Vienna
E-mail: inspektionen@ages.at, ronald.bauer@ages.at - Web site

Polska / Poland

Competent Authority
Joanna Kilkowska - tel:+48 22 492 1170, Andrzej Karczewicz - tel:+48 22 492 1190
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Zabkowska 41, PL - 03 – 736 Warsaw, fax:+48 22 4921199
E-mail: incydenty@urpl.gov.pl - Web site

Portugal - Vigilance

Raquel Alves - tel: + 351 21 798 7297, tel:+351 21 798 7145, fax:+351 21 798 7367
Infarmed - National Authority of Medicines and Health Products, IP Unidade de Vigilância de Produtos de Saúde
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
E-mail: dvps@infarmed.pt - Web site

Romania

Ana Tanase - tel:+40 21 307 2581, fax:+40 21 307 2585
Ministry of Health
1-3, Cristian Popisteanu Street, Sector 1, RO - 010024, Bucharest
E-mail: atanase@ms.ro - Web site

Slovenija / Slovenia

Romana Kajdiz - tel:+386 8 2000 500, fax:+386 8 2000 557
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana
E-mail: meddev.vigilance@jazmp.si, romana.kajdiz@jazmp.si - Web site

Slovenska Republika / Slovakia

Darina Kaminská - tel:+421 2 50701215,
State Institute for Drug Control, Medical Devices Section
Kvetna 11, SK - 825 08 Bratislava 26
E-mail: kaminska@sukl.sk - Web site

Suomi / Finland

Hannu Seitsonen - tel:+358 9 772 920, fax:+358 9 772 2155
Jari Knuuttila - tel:+358 5 0563 8532
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki
E-mail: laitevaarat@valvira.fi - Web site

Sverige / Sweden

Arne Kardell - tel:+46 18 174600, fax:+46 18 503115
Medical Products Agency´ 'Läkemedelsverket'Medical Devices
Box 26, SE-751 03 Uppsala
E-mail: meddev.central@mpa.se - Web site

United Kingdom

TonySant - tel:+44 203 080 7288, fax:+44 203 118 9814
Medicines & Healthcare products Regulatory Agency (MHRA)
Floor 4-Y, Buckingham Palace Road- London SW1W 9SZ
E-mail: aic@mhra.gsi.gov.uk - Web site

Norway / Norge

AIMDD, MDD - Tore Bernt Berg
IVDMD - Bjørn Kristian Berge
Sosial- og helsedirektoratet Norwegian Directorate for Health and Social Affairs
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo,

tel:+47 24 16 3105, fax:+47 24 16 3021,
E-mail: meddev-no@shdir.no - Web site

Iceland / Island

Anna Bjorg Aradottir - tel:+354 510 1900, fax:+354 510 1919
Directorate of Health
Austurstrond 5, IS - 170 Seltjarnarnes
E-mail: annabara@landlaeknir.is - Web site

Switzerland

AIMDD, MDD - Dr. Margit Widmann
IVDMD - Dr. Andreas Schlegel
Swissmedic Medical Devices Division
Erlachstr. 8, CH -3000 Bern 9,

tel:+41 31 324 9180, fax:+41 31 322 7646, Web site
E-mail: margit.widmann@swissmedic.ch, andreas.schlegel@swissmedic.ch, materiovigilance@swissmedic.ch

Lichtenstein

R. Kieber - tel:+423 236 6633, fax:+423 236 7564
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail:info@ag.llv.li - Web site

Turkey

Hande Turan, Adem Ünal, A.Volkan Keles -

tel:+90 312 218 30 71/72/73, fax:+90 312 218 30 59
T.C. Saglik Bakanligi, Ilaç ve Eczacilik Genel Müdürlügü,
Tibbi Cihaz Hizmetleri Dairesi Baskanligi, Piyasa Gözetimi ve Denetimi Subesi

Ministry of Health, DG for Pharmaceuticals and Pharmacy
Department of Medical Device Services, Market Surveillance Section
Mithatpasa Caddesi No:3, Sihhiye 06434, ANKARA - TURKEY
E-mail: meddev.vigilance@iegm.gov.tr - Web site