Clinical investigation contact points within the national competent authorities

Belgie / Belgique / BelgiumBelgie / Belgique / Belgium

MDD AIMDD
Greet Musch, Steve Eglem
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: 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

Inger Eva Küne - tel:+45 72 22 74 00, fax:+45 44 88 9599
Danish Health and Medicines Autority
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

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

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. Antonio Parisi, Adele Misticoni Consorti - tel:+39 06 5994 225/2886, fax:+39 06 5994 3776
Ministry of Health, Department of Innovation- Directorate General of Medical Devices and Medecine
via Giorgio Ribotta 5, IT - 00144 Roma
E-mail: dgfdm@postacert.sanita.it, a.parisi@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

Dr. Gerald Scharll - tel: +352 2478 5634, fax: +352 2620 3296
Direction de la Santé
Villa Louvigny / allée Marconi, L-2120 Luxembourg
E-mail: gerard.scharll@ms.etat.lu

MaltaMalta

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: tristan-charles.camilleri@msa.org.mt, Web site

MagyarorszagMagyarorszag / 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

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
Postal address: P.O. Box 2680, NL - 3500 BS Utrecht, Visitors address: St. Jacobstraat 16, NL - 3511 BS Utrecht
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
Zabkowska 41, PL - 03 – 736 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 21 307 2689, fax:+40 21 307 2585
Ministry of Health
1-3, Cristian Popisteanu Street, Sector 1, RO - 010024, Bucharest
E-mail: mdevice@ms.ro

SlovenijaSlovenija / Slovenia

Igor Lipuscek, Anja Pucer - tel:+386 8 2000 500, fax:+386 8 2000 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, JAZMP
Ptujska ulica 21, SI-1000 Ljubljana
E-mail: meddev@jazmp.si

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.gsi.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

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

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

Cihad Göker
Ministry of Health, General Directorate of Pharmaceuticals and Pharmacy
Soğutozu Mah. 2176. Sok. No.5, Kat: 10 06520 Cankaya / ANKARA / TURKEY
Tel: +90 312 2183083
E-mail: cihad.goker@titck.gov.tr