Mercato interno, industria, imprenditoria e PMI

Contacts

Contacts

European Commission

National competent authorities

Contact points

België / Belgique / Belgien / Belgium

MDD AIMDD -  IVDMD
Director General : H. Malonne
Head of Medical Device Unit : A. Jauniaux - tel:+32 2 528 42 59
FAMHP - Federal Agency for Medicines and Health Products
Place Victor Horta 40, box 40, B - 1060, Brussels, fax:+32 2 528 4120
E-mail: meddev@@afmps.be, ivd@afmps.be - Web site

Bulgaria

Executive Director of BDA: Bogdan Kirilov, M.Pharm.
Head of Division 'Medical devices': Todor Darakchiev
Bulgarian Drug Agency
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 34 83, fax:+359 2 890 34 34
E-mail: todor.darakchiev@bda.bg, bda@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

Virginia Safra - 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: medicaldevices@eof.gr, vsafra@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

France

Thierry Sirdey  - tel:+33 1 55 87 37 75 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: dmcdiv@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

Head of Unit: 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

Medical Device Evaluation Department - tel: ++371 67 078 466, tel: +371 67078466
State Agency of Medicines
15 Jersikas street, LV - 1003 Riga
E-mail: 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
Division de la pharmacie et des médicaments

Villa Louvigny - allée Marconi, L - 2120 Luxembourg
Tél. Direct (+352) 247 85606 / Secrétariat (+352) 247 85612
E-mail: meddevices@ms.etat.lu, invitro-meddevices@ms.etat.lu, meddevices.vigilance@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

Magyarorszag / Hungary

Kornel Szerdi dr.- tel:+36 1 886 9329, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: amd.vig@ogyei.gov.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 Health and Youth Care Inspectorate, IGJ information office (Meldpunt)
- tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Health and Youth Care Inspectorate
Visitor’s address: Stadsplateau 1 | 3521 AZ | Utrecht,  Postal address: Postbus 2518 | 6401 DA | Heerlen
E-mail: meldpunt@igj.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 217987281
E-mail: infarmed@infarmed.pt, daps@infarmed.pt - Web site

Romania

Ioana Tene
Oana Arsenescu

tel: +40 21.222.86.52, +40 21 260.01.58, +40 21 260.01.59
fax: +40 21.222.86.83
National Agency for Medicines and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: ioana.tene@anmdm.ro, oana.arsenescu@anmdm.ro - Web site

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
Slovenčeva ulica 22, 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
E-mail: marek.slavik@sukl.sk - Web site

Suomi / Finland

Heikki Mattlar
Valvira - National Supervisory Authority for Welfare and Health

Mannerheimintie 103b, P.O. box 210, FIN - 00281 Helsinki, tel:+358 295 209 111
E-mail: heikki.mattlar@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)
10 South Colonnade, Canary Wharf, London E14 4PU
Tel: 020 3080 6901     Mob: 07721 231692
E-mail: graeme.tunbridge@mhra.gov.uk - Web site

Norway / Norge

Petter Alexander Strømme, Bjørn Kristian Berge
Statens legemiddelverk/ Norwegian Medicines Agency
Postboks 6167 Etterstad, N-0602 Oslo, tel:+47 22 89 77 00
E-mail: meddev-no@legemiddelverket.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
Medical Devices Division

Hallerstrasse 7, 3012 Bern, Switzerland
E-mail: medical.devices@swissmedic.ch - Web site 

Liechtenstein

Martin Stricker, tel:+423 236 73 36, fax:+423 236 75 64
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: martin.stricker@llv.li - info.ag@llv.li - Web site

Turkey

Turkish Medicines and Medical Devices Agency (TITCK) 
Ministry of Health
Turkish Medicines and Medical Devices Agency
Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara/ TURKEY
E-mail: md.ivd@titck.gov.tr - Web site

Vigilance contact points

België / Belgique / Belgien / Belgium

MDD AIMDD - IVDMD
Head of Vigilance Division: Th. Roisin

MDD AIMDD Vigilance: C. Driesmans
tel: +32 2 528 4418 
E-mail: meddev@afmps.be

IVDMD Vigilance: J. Poels
tel: +32 2 528 4449
E-mail: ivd@afmps.be

FAMHP- Federal Agency for Medicines and Health Products
Place Victor Horta 40, box 40, B - 1060, Brussels, fax:+32 2 528 4120
Web site

Bulgaria

Executive Director of BDA: Bogdan Kirilov, M.Pharm.
Head of Division 'Medical devices': Todor Darakchiev
Bulgarian Drug Agency
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 34 83, fax:+359 2 890 34 34
E-mail: todor.darakchiev@bda.bg, bda@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 - Web site

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

Ioannis Argyropoulos – tel: +357 22 605785
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

Medical Device Evaluation Department - tel: +371 67 078 466, tel: +371 67078466
State Agency of Medicines,
15 Jersikas street, LV - 1003 Riga
E-mail: 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 - tel : +352 247 85612
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: meddevices.vigilance@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

Magyarorszag / Hungary

Kornel Szerdi dr.- tel:+36 1 886 9329, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: amd.vig@ogyei.gov.hu

Nederland / Netherlands

Sietske Eerens, Esther Klinckenberg - tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Health and Youth Care Inspectorate, IGJ Information Office (Meldpunt)
Visitors address: Stadsplateau 1 | 3521 AZ | Utrecht, postal address: Postbus 2518 | 6401 DA | Heerlen
E-mail: meldpunt@igj.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:+351 211 117 559
Infarmed - National Authority of Medicines and Health Products, IP Unidade de Vigilância de Produtos de Saúde da Direção 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

Oana Arsenescu
Georgeta Herta

tel: +40 21.222.86.52, +40 21 260.01.58, +40 21 260.01.59
fax: +40 21.222.86.83
National Agency for Medicines and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.ro, georgeta.herta@anmdm.ro - Web site

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
E-mail: darina.kaminska@sukl.sk - Web site

Suomi / Finland

Tarja Vainiola
Valvira - National Supervisory Authority for Welfare and Health

Mannerheimintie 103b, P.O. box 210, FIN - 00281 Helsinki, tel:+358 295 209 111
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
Medicines & Healthcare products Regulatory Agency (MHRA)
10 South Colonnade, Canary Wharf, London E14 4PU
E-mail: aic@mhra.gov.uk - Web site

Norway / Norge

AIMDD, MDD IVDMD - – Raymond Ludvigsen / Bjørn Kristian Berge
Statens legemiddelverk/ Norwegian Medicines Agency
Postboks 6167 Etterstad, N-0602 Oslo, tel:+47 22 89 77 00 
E-mail:  meddev-no@legemiddelverket.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
Medical Devices Division

Hallerstrasse 7, 3012 Bern, Switzerland
E-mail: materiovigilance@swissmedic.ch - Web site 

Liechtenstein

Martin Stricker, tel:+423 236 73 36, fax:+423 236 75 64
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: martin.stricker@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

Clinical investigation contact points

Belgie / Belgique / BelgiumBelgië / Belgique / Belgien / Belgium

MDD AIMDD - IVDMD
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

BulgariaBulgaria

Head of Division 'Medical devices': Todor Darakchiev
Bulgarian Drug Agency
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 34 83, fax:+359 2 890 34 34
E-mail: todor.darakchiev@bda.bg, bda@bda.bg - Web site

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

Romana Katalinić - tel: +385 1 4607 541
Ministry of Health of the Republic of Croatia
Ksaver 200a, 10000 Zagreb
E-mail: romana.katalinic@miz.hrWeb site

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

Ulf Schriever - tel:+49 228 207 4137, 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

Tom Melvin - 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: devices@hpra.ie - Web site

ElladaEllada / Greece

Evgenia Fouza-Stavropoulou - tel:+30 213 2040 335
Deputy Head of Pharmaceutical Studies and Research Division
National Organization for Medicines (EOF) - Greece
e-mail: efouza@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 67 078 466, 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

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

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

MagyarorszagMagyarorszag / Hungary

Kornel Szerdi dr.- tel:+36 1 886 9329, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary
E-mail: amd.vig@ogyei.gov.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 

Judite Neves, - tel: + 351 21 798 7293, tel: + 351 21 798 7294, tel: + 351 21 798 5272, 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 - Web site

RomaniaRomania

Margareta Mihalache
Oana Arsenescu

tel: +40 21.222.86.52, +40 21 260.01.58, +40 21 260.01.59
fax: +40 21.222.86.83
National Agency for Medicines and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: margareta.mihalache@anmdm.ro, oana.arsenescu@anmdm.ro - Web site

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
Slovenčeva ulica 22, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, marcia.podborsek@jazmp.si - Web site

Slovenska RepublikaSlovenska Republika / Slovakia

Marek Slávik - tel: +421 2 50701307
Boris Zajac – tel: +421 2 50701224
State Institute for Drug Control, Medical Devices Section
Kvetná 11, SK-825 08 Bratislava
E-mail: marek.slavik@sukl.sk, boris.zajac@sukl.sk - Web site

SuomiSuomi / Finland

Minna Kymäläinen
Valvira - National Supervisory Authority for Welfare and Health

Mannerheimintie 103b, P.O. box 210, FIN - 00281 Helsinki, tel:+358 295 209 111
E-mail: kirjaamo@valvira.fi - Web site

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

Annie Dhillon - tel:+44 20 3080 6886
Medicines & Healthcare products Regulatory Agency (MHRA)
10 South Colonnade, Canary Wharf, London E14 4PU
E-mail: annie.dhillon@mhra.gov.uk - Web site

NorgeNorway / Norge

Anne-Mari Håkelien - tel: +47 22 89 77 00
Statens legemiddelverk/ Norwegian Medicines Agency
Postboks 6167 Etterstad, N-0602 Oslo, tel:+47 22 89 77 00 
E-mail:  meddev-no@legemiddelverket.no  -  Web site

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, Swiss Agency for Therapeutic Products
Medical Devices Division

Hallerstrasse 7, 3012 Bern, Switzerland
E-mail: clinicaltrials.devices@swissmedic.ch - Web site 

LiechtensteinLiechtenstein

Martin Stricker - tel:+423 236 7336, fax:+423 236 7564
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: martin.stricker@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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