Vigilance contact points within the national competent authorities

Belgie / Belgique / Belgium

MDD AIMDD
Head of Unit : Th. Roisin, S. Vanackere
AFMPS - Agence Fédérale des Medicaments et des Produits de Santé
Place Victor Horta 40, boîte 40, B - 1060, Brussels, tel:+32 2 524 8178 fax:+32 2 524 8120
E-mail: meddev@afmps.be - Web site

IVDMD
Dr. Anne Van Nerom, Jeroen Poels
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, tel:+32 2 642 5392, fax:+32 2 642 5645
E-mail: IVD@wiv-isp.be- Web site

Bulgaria

Head of Department: Vessela Boudinova, Todor Darakchiev
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 3483, fax:+359 2 890 3434
E-mail: vessela.boudinova@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: urgent@sukl.cz, irena.vichova@sukl.cz

croatia flagHrvatska / Croatia

Krunoslav Kranjcec,
Agency for Medicinal products and medical devices
Ksaverska cesta 4, 10 000 Zagreb, tel: +385 1 4884 327, fax: +381 1 4884 110
E-mail:  medpro@halmed.hr,  Krunoslav.kranjcec @halmed.hr - Web site

Danmark / Denmark

Danish Health and Medicines Authority
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, http://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

Sofia Hratkevich - 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
Health Products Regulatory Authority
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: devicesafety@hpra.ie - Web site

Ellada / Greece

Dr. George Aislaitner- tel:+30 213 20 40337, fax:+30 210 65 07585
E-mail: vigilancematerial@eof.gr,
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens
España / Spain

Carmen Abad
Carmen Valls - tel: +34 91 822 5255, fax: +34 91 822 5289
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES - 28022 Madrid
E-mail: psvigilancia@aemps.es - Web site

France

Emilie Alliez - tel:+33 1 55 87 33 46,  fax:+33 1 55 87 37 02
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mails: Exclusively for correspondence between authorities:medicaldevicesvigilance@ansm.sante.fr 
Other purposes: materiovigilance@ansm.sante.fr - Web site

Italia / Italy

Vigilance on Medical Devices
Dr. Rosaria Boldrini - tel: +39 06 5994 2381, fax:+39 06 5994 3812
E-mail: dgfdm@postacert.sanita.it, vigilance@sanita.it, r.boldrini@sanita.it
MDD AIMDD Vigilance - Dr. ssa Marcella Marletta - Dr.ssa Elena Giovani,
tel: +39 06 5994 2910, fax: +39 5994 3812
E-mail: dgfdm@postacert.sanita.it, vigilance@sanita.it , segr.dgfdm@sanita.it
IVDMD Vigilance - Dr. Pietro Calamea
tel: +39 06 5994 2669, fax: +39 06 5994 3266
E-mail: dgfdm@postacert.sanita.it, ivd@sanita.it, p.calamea@sanita.it
Ministry of Health, Department of Planning and Organisation of the National Health Service
Directorate General of Medical Devices, pharmaceutical services and safety in healthcare
Via Giorgio Ribotta 5, IT - 00144 Roma

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

Latvija / Latvia

Daiga Lagzdina - Aivita Vanaga - 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, Aivita.Vanaga@zva.gov.lv

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

Luxembourg

MDD AIMD
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

IVD
Bureau de Contrôle de Qualité  - tel: +352 2478 5632, fax: +352 40 0745
Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: Bcq@ms.etat.lu - Web site

Malta

Tristan Camilleri - tel:+356 21242000, fax:+356 21242406
Malta Competition and Consumer Affairs 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

Magyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Authority for Medical Devices Budapest,
1051, Budapest, Zrínyi street 3, Hungary
E-mail: vigilance@eekh.hu

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. Jacobsstraat 16, NL - 3511 BS Utrecht
E-mail: meldpunt@igz.nl- Web site

Österreich / Austria

Reinhard Berger - tel: +43 50555 36200, Christian Taylor - tel: +43 50555 36438
Federal Office for Safety in Healthcare - (BASG) Bundesamt für Sicherheit im Gesundheitswesen
Institute for Surveillance, Department Medical Devices Surveillance
Traisengasse 5, A-1200 Vienna, fax: +43 50555 36409
E-mail: medizinprodukte@basg.gv.at, - Web site

Polska / Poland

Competent Authority
Andrzej Karczewicz - tel:+48 22 492 11 90, Beata Koziozemska - tel: +48 22 492 11 68
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Zabkowska 41, PL - 03–736 Warsaw, fax:+48 22 492 11 99
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

Igor Lipuscek - 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, igor.lipuscek@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: darina.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 20 3080 7080, fax:+44 203 118 9814
MHRA Devices
151 Buckingham Palace Road- London SW1W 9SZ
E-mail: aic@mhra.gsi.gov.uk - Web site

Norway / Norge

AIMDD, MDD IVDMD - – Raymond Ludvigsen /  Bjørn Kristian Berge
Helsedirektoratet / Norwegian Directorate for Health
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, tel:+47 24 16 3000, fax:+47 24 16 3021,
E-mail: meddev-no@helsedir.no - Web site

Iceland / Island

Haukur Eggertsson - tel:+354 520 2100, fax:+354 561 2170
Icelandic Medicines Agency
Vínlandsleið 14, IS-113 Reykjavík
E-mail: Haukur.Eggertsson@lyfjastofnun.is - Web site

Switzerland

Swissmedic, Swiss Agency for Therapeutical Products
Medical Devices Division
Hallerstrasse 7, CH -3012 Bern
E-mail: materiovigilance@swissmedic.ch - Web site

Liechtenstein

Dr. Christina Zimmer - tel:+423 236 7333, fax:+423 236 7564
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: christina.zimmer@llv.li - 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