Clinical investigation contact points within the national competent authorities

 Belgie / Belgique / Belgium

MDD AIMDD
Frédérique Meulders, Carine Bakwa 
Federal Agency for Medicines and Health Products
Place Victor Horta 40, boîte 40, B - 1060, Brussels, tel:+32 2 524 8113 fax:+32 2 524 8120
E-mail: frederique.meulders@fagg-afmps.be, carine.bakwa@fagg-afmps.be

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

 Bulgaria

Head of Department: Dr. Lyubomir Dimitrov - tel:+359 2 890 3483
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia,
E-mail: lyubomir.dimitrov@bda.bg

 Ceska Republika / Czech Republic

Irena Víchová - tel:+420 272 185705, fax:+420 272 15764
State Institute for Drug Control
Šrobárova 48, 100 41 Prague 10
E-mail: mailto:irena.vichova@sukl.cz

 Danmark / Denmark

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

 Deutschland / Germany

Dr. Thomas Fischer - tel:+49 228 207 3369, 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

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

 Ireland / Eire

Niall MacAleenan - tel:+353 1 676 4971, fax:+353 1 676 78363
Irish Medicines Board, Medical Devices Department
Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: niall.macaleenan@imb.ie, clinical.ix@imb.ie -  Web site

 Ellada / 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

 España / 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

 France

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

 Italia / Italy

Dr. Antonio Parisi, Adele Misticoni Consorti - tel:+39 06 5994 225/2886, fax:+39 06 5994 3776 
Ministry of Health, Department of Planning and Organisation of the National Health service - Directorate General of Medical Devices, pharmaceutical services and safety in healthcare
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: dgfdm@postacert.sanita.it, a.parisi@sanita.it, a.misticoniconsorti@sanita.it

 Kypros / Kibris / Cyprus

Androulla Stylianou - 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

 Latvija / Latvia

Andis Vilums - tel: +371 6707466, fax: +371 67078428
State Agency of Medicines, Department of Medical Devices Assessment
72 Brivibas Str. Riga, LV-1011
E-mail: andis.viliums@zva.gov.lv

 Lietuva / 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
Zalgirio str. 92, LT- 09303 Vilnius
E-mail: julius.tertelis@vaspvt.gov.lt, vaspvt@vaspvt.gov.lt

 Luxembourg

 

 Malta

Tristan Camilleri, David Pulis - 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

 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

 Nederland / Netherlands

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

 Österreich / Austria

Doris Schweighofer - tel:+43 50 555 36435, fax:+43 50 555 36409
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
Institut Inspektionen, Medizinprodukte und Hämovigilanz - AGES PharmMed
Schnirchgasse 9, A-1030 Vienna
E-mail: inspektionen@ages.at

 Polska / Poland

Andrzej Karczewicz - tel: +48 22 492 11 90, Malgorzata Daniluk - tel: +48 22 492 11 44
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

  Portugal - Vigilance

Judite Neves,  Mariana Madureira - 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

 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

 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: igor.lipuscek@jazmp.si , meddev@jazmp.si

 Slovenska Republika / Slovakia

 

 Suomi / Finland

Kimmo Linnavuori - tel:+358 9 7729 2189, fax:+358 9 7729 2155
Valvira - National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4, P.O.Box 210, FIN - 00531 Helsinki
E-mail: kimmo.linnavuori@valvira.fi

 Sverige / Sweden

Vendela Schnittger - tel:+46 18 174614, fax:+46 18 503115
Medical Products Agency´ 'Läkemedelsverket' Medical Devices
Box 26, SE-751 03 Uppsala
E-mail: vendela.schnittger@mpa.se

 United Kingdom

Daniella Smolenska - tel:+44 203 080 7235, fax:+44 203 118 9808
Medicines & Healthcare products Regulatory Agency (MHRA)
Floor 5 M, Buckingham Palace Road- London SW1W 9SZ
E-mail: daniella.smolenska@mhra.gsi.gov.uk - Web site

 Norway / Norge

Trude Andreassen - tel:+47 24 16 3557
Sosial- og helsedirektoratet Norwegian Directorate for Health and Social Affairs
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo, 3105
E-mail: meddev-no@shdir.no,  tan@helsedir.no

 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

Dr. Isabel Scuntaro  -   tel:+41 31 324 9751, fax:+41 31 322 7646
Swissmedic Medical Devices Division
Hallerstrasse 7, CH -3000 Bern 9
E-mail: clinicaltrials.devices@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   

Hilal Ilbars, Burçak Deniz Dedeoglu
T.R. Ministry of Health
General Directorate of Pharmacy and Pharmaceuticals
tel:+ 90312 3091141/1223, fax:+90312 3091178, tel:+ 90312 3091141/1223, fax:+90312 3091178
E-mail: hilal.ilbars@iegm.gov.tr, bdeniz.dedeoglu@iegm.gov.tr