Growth

Contacts

Contacts

European Commission

National Competent Authorities

Contact points

België / Belgique / Belgien / Belgium

MDD AIMDD
Head of the Medical Device Unit : Hugues Malonne
Coordinator of MD Unit : Alexandre Jauniaux - tel:+32 2 528 42 59
FAMHP - Federal Agency for Medicines and Health Products
Place Victor Horta 40, boîte 40, B - 1060, Brussels, fax:+32 2 528 4120
E-mail: meddev@fagg.be - Web site

IVDMD
Dr.Sc.Biol. Christel Van Campenhout
Dr. Anne Van Nerom, DVM
- tel:+32 2 642 55 40
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, fax:+32 2 642 56 45
E-mail: Christel.VanCampenhout@wiv-isp.be, Anne.VanNerom@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 34 83, fax:+359 2 890 34 34
E-mail: vessela.boudinova@bda.bg, darakchiev@bda.bg - Web site

Ceska Republika / Czech Republic

Katerina Pavlikova, Jakub Machalek
Ministry of Health Department of Pharmacy, Medical Devices Unit
Palackého náměstí 4, CZ - 12801 Prague 2, tel:+420 224 972422, +420 224 972385,
E-mail: medicaldevices@mzcr.cz - Web site

croatia flag Hrvatska / Croatia

Suzana Oštarčević
Agency for Medicinal products and medical devices
Ksaverska cesta 4, 10 000 Zagreb, tel: +385 1 4884 300, fax: +381 1 4884 110
E-mail: suzana.ostarcevic@halmed.hr- Web site

Danmark / Denmark

Thomas Weiss Møller
Danish Medicines Agency
Pharmacovigilance and Medical Devices
Axel Heides Gade 1, DK - 2300 - Kobenhavn, tel:+45 44 88 9667
E-mail: med-udstyr@dkma.dk, Web site

Deutschland / Germany

AIMDD, MDD, IVDMD Legislation
Susanne Conze
- tel:+ 49 228 941-3322, Dr. Matthias Neumann - tel:+49 228 941-2636
Federal Ministry of Health
Friedrichstr. 108 - 10117 Berlin, fax:+ 49 228 941-4946
E-mail: mailto:medizinprodukte@bmg.bund.de - Web site

AIMDD, MDD, IVDMD Designating
Dr. Rainer Edelhaeuser
- tel:+49 228 97794-0, fax:+49 228 97794-44
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)
E-mail: zlg@zlg.nrw.de - Web site

AIMDD CA - Dr. Ekkehard Stößlein - tel:+49 228 207 5384
MDD CA - Dr. Karl Broich - tel:+49 228 207 5355
IVDMD CA - 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 CA - 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 - Website

Eesti / Estonia

Health Board, Medical Devices Department
1a Põllu st., EE - Tartu 50303,
E-mail: MSO@terviseamet.ee - Web site

Ireland / Eire

Nial MacAleenan- tel:+353-1-6764971, fax:+353-1-6344033
Health Products Regulatory Authority
Kevin O’Malley House, Medical Devices Department, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: niall.macaleenan@hpra.ie - Web site

Ellada / Greece

Maria Perpiraki - tel:+30 21 06 50 74 07, fax:+30 21 06 50 74 50
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens, E-mail: perpiraki@eof.gr - Web site

España / Spain

Mrs. Carmen Abad - tel: +34918225274, fax: +34918225289
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES - 28022 Madrid
E-mail: sgps@aemps.es, Web site http://www.aemps.gob.es/

France

Dr. Jean-Claude Ghislain - tel:+33 1 55 87 4271 fax:+33 1 55 87 37 42
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mail: dedim.ugsv@ansm.sante.fr - Web site

Italia / Italy

Head of Unit 3 - Dr.Annamaria Donato - tel:+39 06 5994 3063, fax:+39 06 5994 3776
Head of Unit 4 - Dr. Pietro Malara - tel:+39 06 5994 2468.
Ministry of Health, - Directorate General of Medical Devices and Pharmaceutical Services
via Giorgio Ribotta 5, IT - 00144 Roma,
E-mail: an.donato@sanita.it, p.malara@sanita.it

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

Deputy Director: Dace Ķikute - tel:+371 67078424
State Agency of Medicines
15 Jersikas street, LV - 1003 Riga
E-mail: Dace.kikute@zva.gov.lv, info@zva.gov.lv

Lietuva / Lithuania

Director: Nora Ribokiene - tel:+370 5 261 51 77, fax:+370 5 212 73 10
The State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania
Jeruzales str. 21, LT-08420 Vilnius
E-mail: vaspvt@vaspvt.gov.lt - Web site

Luxembourg

Ministère de la Santé, Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: meddevices@ms.etat.lu - Web site

Malta

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mt, Web site: http://mccaa.org.mt/

Magyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: p.bunyitai@enkk.hu , amd@enkk.hu

Nederland / Netherlands

Notification/Registration
CIBG Farmatec-BMC, Front Office -
tel: +31 70 340 6161
Postal address: PO box 16114, NL - 2500 BC The Hague, Visitors address: Wijnhaven 16, NL - 2511 GA Den Haag
E-mail: Medische_hulpmiddelen@minvws.nl - Web site

Law Enforcement (a.o. vigilance and market surveillance)
Dutch Healthcare Inspectorate, IGZ information office (Meldpunt)
- tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Healthcare Inspectorate
Stadsplateau 1 | 3521 AZ | Utrecht,  Postbus 2518 | 6401 DA | Heerlen
E-mail: meldpunt@igz.nl - Web site

Österreich / Austria

Dr. Wolfgang Ecker - tel:+43 1 71100 4206
Dr. Martin Renhardt - tel:+43 1 711004487
Ing. Andreas Gutruf - tel:+43 1 711004602
Federal Ministry of Health
Dept. Pharmaceuticals and Medical Devices
Radetzkystrasse 2, 1030 Wien/Vienna
E-mail: meddev@bmgf.gv.at - Web site

Polska / Poland

Competent Authority
Andrzej Karczewicz - tel:+48 22 492 11 90
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, fax:+48 22 492 11 99
E-mail: incydenty@urpl.gov.pl - Web site

Legislation - Designation of NBs
Sebastian Migdalski -
tel: +48 22 6349324, fax:+48 22 8316557
Ministry of Health
Miodowa 15, PL - 00-952 Warsaw
E-mail: s.migdalski@mz.gov.pl, Web site

Portugal

Judite Neves, Pharm.D., Director of Health Products Directorate
Infarmed - National Authority of Medicines and Health Products, IP
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
tel: + 351 21 798 7100, tel:+351 21 798 7235, fax:+351 21 798 7316
E-mail: infarmed@infarmed.pt, daps@infarmed.pt - Web site

Romania

Lazar Iordache, tel: +40 21 222 8652
Margareta Mihalache - tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro margaretamihalache@ms.ro - web site: www.ms.ro

Slovenija / Slovenia

Marcia Elena Podboršek - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, marcia.podborsek@jazmp.si - Web site

Slovenska Republika / Slovakia

Dr. Marek Slávik - tel:+421 2 50701307
State Institute for Drug Control, Medical Devices Section
Kvetna 11, SK - 825 08 Bratislava 26,
E-mail: marek.slavik@sukl.sk - Web site

Suomi / Finland

Dr. Jussi Holmalahti, Director - tel:+358 9 772 920, fax:+358 9 772 2138
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki,
E-mail: Jussi.holmalahti@valvira.fi, kirjaamo@valvira.fi - Web site

Sverige / Sweden

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

United Kingdom

Graeme Tunbridge
Group Manager – Devices Regulatory Affairs
Medicines & Healthcare products Regulatory Agency (MHRA)
151 Buckingham Palace Road, London, SW1W 9SZ
Tel: 020 3080 6901     Mob: 07721 231692
E-mail: graeme.tunbridge@mhra.gov.uk - Web site

Norway / Norge

Ingeborg Hagerup-Jenssen, Bjørn Kristian Berge
Helsedirektoratet / Norwegian Directorate for Health

P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, tel:+47 24 16 31 00 , fax:+47 24 16 30 21,
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 Therapeutic Products
Hallerstrasse 7, CH -3012 Bern 7,
E-mail: medical.devices@swissmedic.ch - Web site

Liechtenstein

Dr. Christina Zimmer, tel:+423 236 73 33, fax:+423 236 75 64
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: christina.zimmer@llv.li - info.ag@llv.li - Web site

Turkey

Tuncay Bayrak -
Ministry of Health
Turkish Medicines and Medical Devices Agency
Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara/ TURKEY
E-mail: tuncay.bayrak@titck.gov.tr - Web site

Vigilance contact points

België / Belgique / Belgien / Belgium

MDD AIMDD
Head of Unit : Th. Roisin, C. Driesmans
FAMHP- Federal Agency for Medicines and Health Products
Place Victor Horta 40, boîte 40, B - 1060, Brussels, tel:+32 2 528 4418 fax:+32 2 528 4120
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

Ivana Justová
State Institute for Drug Control
Šrobárova 48, 100 41 Prague 10, Czech Republic, tel: +420 272 185 794, fax: +420 272 185 764
E-mail: urgent@sukl.cz , ivana.justova@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 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, 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 Ratusnaja - tel:+372 744 7425
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

Eleni Papaioannou, MD - tel:+30 213 20 40542, fax:+30 210 65 49585
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 Malara
tel: +39 06 5994 2468
E-mail: dgfdm@postacert.sanita.it, ivd@sanita.it
Ministry of Health,
Directorate General of Medical Devices and Pharmaceutical Services
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, Inese Vectirāne - 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, inese.vectirane@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
Ministère de la Santé, Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: meddevices@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

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mt, Web site: http://mccaa.org.mt/

Magyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices,
1051, Budapest, Zrínyi street 3, Hungary
E-mail: vigilance@enkk.hu

Nederland / Netherlands

Esther Klinckenberg, Lindy van de Westelaken - tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Healthcare Inspectorate
Stadsplateau 1 | 3521 AZ | Utrecht,  Postbus 2518 | 6401 DA | Heerlen
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
Al. Jerozolimskie 181C, 02-222 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

Margareta Mihalache - tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro; margaretamihalache@ms.ro - web site: www.ms.ro

Slovenija / Slovenia

Marcia Elena Podboršek - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
Slovenčeva ulica 22, SI - 1000 Ljubljana,
E-mail: meddev.vigilance@jazmp.si, marcia.podborsek@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

Tony Sant - tel:+44 20 3080 7080, fax:+44 203 118 9814
MHRA Devices
151 Buckingham Palace Road- London SW1W 9SZ
E-mail: aic@mhra.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

The Ministry Of Health, Turkish Medicine and Medical Device Agency
Vice Presidency of Inspectorate, Medical Device Vigilance Unit

Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara/ TURKEY
E-mail: meddev.vigilance@titck.gov.tr

Aydın Kaplan
Turkish Medicines and Medical Devices Agency
E-mail: aydin.kaplan@titck.gov.tr

Tuncay Bayrak
Turkish Medicines and Medical Devices Agency
E-mail: tuncay.bayrak@titck.gov.tr

Clinical Investigation contact points

Belgie / Belgique / BelgiumBelgië / Belgique / Belgien / Belgium

MDD AIMDD
Greet Musch, Steve Eglem
FAMHP - Federal Agency for Medicines and Health Products
Place Victor Horta 40, boîte 40, B - 1060, Brussels, tel:+32 2 528 4113 fax:+32 2 528 4120
E-mail: greet.musch@fagg.be, steve.eglem@fagg.be

IVDMD
Dr. Anne Van Nerom,
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, tel:+32 2 642 5040, fax:+32 2 642 5645
E-mail: Anne.VanNerom@wiv-isp.be,

BulgariaBulgaria

Todor Darakchiev - tel:+359 2 890 3483
Iskra Ivanova - tel +359 2 890 35 11 - Fax: +359 2 890 34 34
Bulgarian Drug Agency - Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia,
E-mail: todor.darakchiev@bda.bg - iskra.ivanova@bda.bg

Ceska RepublikaCeska Republika / Czech Republic

Irena Víchová - tel:+420 272 185701, fax:+420 272 15764
State Institute for Drug Control
Šrobárova 48, 100 41 Prague 10
E-mail: zp@sukl.cz

HrvatskaHrvatska / Croatia

Suzana Oštarčević,
Agency for Medicinal products and medical devices
Ksaverska cesta 4, 10 000 Zagreb, tel: ++385 1 4884 300
E-mail: Suzana.ostarcevic@halmed.hr

DanmarkDanmark / Denmark

Kristin Jøranli Astrup - tel:+45 44 88 95 95, fax:+45 44 88 9599
Danish Medicines Agency
Axel Heides Gade 1, DK - 2300 - Kobenhavn
E-mail: med-udstyr@dkma.dk

DeutschlandDeutschland / Germany

Dr. Wolfgang Lauer - tel:+49 228 207 5355, fax:+49 228 207 5300
Federal Institute for Drugs and Medical Devices
Kurt Georg Kiesinger Allee 3, D - 53175 Bonn
E-mail: medizinprodukte@bfarm.de

Eesti / Estonia

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

EireIreland / Eire

Niall MacAleenan - tel:+353 1 676 4971, fax:+353 1 676 7836
Health Products Regulatory Authority
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: hpradevices@hpra.ie - Web site

ElladaEllada / Greece

Dr. Fotini Tzavella - tel:+30 210 65 07546, fax:+30 210 65 07585
National Organization for Medicines
284 Mesogion Ave, GR- 15562 Holargos, Athens
E-mail: ftzavella@eof.gr

EspañaEspaña / Spain

Mª Concepción Rodríguez Mateos - tel: +34 91 822 5270, fax: +34 91 822 5289
Agencia Espaňola de Medicamentos y Productos Sanitarios
C/ Campezo 1, Edificio 8, ES - 28022 Madrid
E-mail: psinvclinic@aemps.es - Web site

FranceFrance

Dr. Catherine Raveau-Landon - tel:+33 1 55 873687 fax:+33 1 55 873717
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex
E-mail: catherine.raveau-landon@ansm.sante.fr

ItaliaItalia / Italy

Dr. Pietro Calamea tel: +39 06 5994 2669, fax: +39 06 5994 3266 Dr. Adele Misticoni Consorti - tel:+39 06 5994 2886
Ministry of Health, - Directorate General of Medical Devices and Pharmaceutical Servicesvia Giorgio Ribotta 5, IT - 00144 Roma
via Giorgio Ribotta 5, IT - 00144 Roma
E-mail: dgfdm@postacert.sanita.it, p.calamea@sanita.it, a.misticoniconsorti@sanita.it

KyprosKypros / Kibris / Cyprus

Christiana Valianti - tel:+357 22 605574, fax:+357 22 468427
Cyprus Medical Devices Competent Authority
Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia,
E-mail: cymda@mphs.moh.gov.cy

LatvijaLatvija / Latvia

Andis Vilums - tel: +371 6707466, fax: +371 67078428
State Agency of Medicines, Department of Medical Devices Assessment
15 Jersikas Str. Riga, LV-1003
E-mail: andis.vilums@zva.gov.lv

LietuvaLietuva / Lithuania

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
Jeruzalès str. 21, LT- 08420 Vilnius
E-mail: julius.tertelis@vaspvt.gov.lt, vaspvt@vaspvt.gov.lt

LuxembourgLuxembourg

Direction de la Santé
Villa Louvigny / allée Marconi, L-2120 Luxembourg
E-mail: meddevices@ms.etat.lu

MaltaMalta

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mt, Web site: http://mccaa.org.mt/

MagyarorszagMagyarorszag / Hungary

Peter Bunyitai - tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: vigilance@enkk.hu

NederlandNederland / Netherlands

MDD - AIMD: Dr. P.W. Riem Vis - tel:+31 70 304 1694, fax:+31 70 304 1570
IVD: dr. ing. Kees Maquelin
Dutch Healthcare Inspectorate (DHCI) IGZ Loket
Stadsplateau 1 | 3521 AZ | Utrecht,  Postbus 2518 | 6401 DA | Heerlen
E-mail: meldpunt@igz.nl

ÖsterreichÖsterreich / Austria

Dipl.-Ing. Dr. Ronald Bauer - tel:+43 50 555 36420, fax:+43 50 555 36409
Head of Department Clinical Trials
BASG - Bundesamt für Sicherheit im Gesundheitswesen
AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Institute Surveillance
Traisengasse 5
A-1200 Wien | Vienna
E-mail: ronald.bauer@ages.at

PolskaPolska / Poland

Andrzej Karczewicz - tel: +48 22 492 11 90, Beata Koziożemska - tel: +48 22 492 11 68
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, fax:+48 22 492 11 99
E-mail: incydenty@urpl.gov.pl

Portugal - Vigilance

Judite Neves, - tel: + 351 21 798 7235/7293/7294, fax:+351 21 798 7281
Infarmed - National Authority of Medicines and Health Products, IP Health Products Directorate
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
E-mail: daps@infarmed.pt

RomaniaRomania

Margareta Mihalache - tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro margaretamihalache@ms.ro - web site: www.ms.ro

SlovenijaSlovenija / Slovenia

Marcia Elena Podboršek - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, marcia.podborsek@jazmp.si - Web site

Slovenska RepublikaSlovenska Republika / Slovakia

Marek Slávik - tel: +421 2 50701307
State Institute for Drug Control, Medical Devices Section
Kvetná 11, SK-825 08 Bratislava 26
E-mail: marek.slavik@sukl.sk

SuomiSuomi / Finland

Kimmo Linnavuori - tel:+358 295 209 511, fax:+358 295 209 702
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki
E-mail: kimmo.linnavuori@valvira.fi

SverigeSverige / Sweden

Vendela Schnittger - tel:+46 18 174600, fax:+46 18 503115
Medical Products Agency 'Läkemedelsverket' Medical Devices
Box 26, SE-751 03 Uppsala
E-mail: meddevcentral@mpa.se

United KingdomUnited Kingdom

Daniella Smolenska - tel:+44 20 3080 7363, fax:+44 203 118 9808
Medicines & Healthcare products Regulatory Agency (MHRA)
4 Yellow, 151 Buckingham Palace Road- London SW1W 9SZ
E-mail: daniella.smolenska@mhra.gov.uk - Web site

NorgeNorway / Norge

Anne-Mari Håkelien / Ingeborg Hagerup-Jenssen - tel:+47 24 16 30 00
Helsedirektoratet / Norwegian Directorate of Health
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, 3105
E-mail: meddev-no@helsedir.no

IslandIceland / 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

SwitzerlandSwitzerland

Swissmedic Medical Devices Division
Hallerstrasse 7, CH -3000 Bern 9
E-mail: clinicaltrials.devices@swissmedic.ch

LiechtensteinLiechtenstein

Dr. Christina Zimmer - tel:+423 236 7336, 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

TurkeyTurkey

Ahmet Gökhan Demir
Ministry of Health, Turkish Medicines and Medical Devices Agency
Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara/ TURKEY
E-mail: ahmet.demir@titck.gov.tr

Tuncay Bayrak
Ministry of Health, Turkish Medicines and Medical Devices Agency
Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara/ TURKEY
E-mail: tuncay.bayrak@titck.gov.tr

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