Clinical Study
MEDICAL DEVICE 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, Web site
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 Web site
Ceska Republika / Czech Republic
Daniela Rrahmaniová - tel:+420 224 972716, fax:+420 224 916002
Ministry of health
Palackého námestí 4, CZ - 12801 Prague 2
E-mail: Daniela.Rrahmaniova@mzcr.cz Web site
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
Web sites: www.medicinskudstyr.dk, www.medicaldevices.dk
Deutschland / Germany
Dr. Dirk Wetzel - tel:+49 228 207 5235, 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 Web site BfArM Web site PEI
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 Web site
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 Web site
España / Spain
Mª Concepción Rodríguez Mateos - tel: +34 91 822 5270, fax: +34 91 822 5289
Ministerio Sanidad y Consumo Agencia Espaňola de Medicamentos y Productos Sanitarios
Parque Empresarial Las Mercedes, Edificio 8. C/ Campezo 1,
ES - 28022 Madrid
E-mail: psvinvclinic@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 Web site
Italia / Italy
Head of Unit 6 - Dr. Annamaria Donato
Ing. Maria Chiara Orlandi
Ministry of Labour, Health and Social Affairs, Department of Innovation, Directorate General of Medicine and Medical Devices
via Giorgio Ribotta 5, IT - 00144 Roma -
tel:+39 06 5994 3063, fax:+39 06 5994 3776
E-mail: an.donato@sanita.it, mc.orlandi-esterno@sanita.it Web site
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 Web site
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 Web site
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 Web site Web site2
Luxembourg
Malta
Tristan Camilleri, David Pulis - tel:+356 21242000, fax:+356 21242406
Consumer and Industrial Goods Directorate Malta Standards 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 Web site
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 Web site
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 Web site
Polska / Poland
Joanna Kilkowska, Ewa Dytkowska Pózniak - tel:+48 22 492 1170, fax:+48 22 492 1190
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Zabkowska 41, PL - 03 – 736 Warsaw, fax:+48 22 4921199
E-mail: joanna.kilkowska@urpl.gov.pl, ewa.dytkowska@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 Unidade de Vigilância de Produtos de Saúde
Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa
E-mail: daps@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
Romana Kajdiz - 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: romana.kajdiz@jazmp.si, meddev@jazmp.si Web site
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 Web site
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 Web site
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 Web site
Iceland / Island
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 Web site
Lichtenstein
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 Web site
