LIST OF MEDICAL DEVICE CONTACT POINTS WITHIN THE NATIONAL COMPETENT AUTHORITIES

Belgie / Belgique / Belgium

MDD AIMDD
Head of the Medical Device Unit : Wim Penninckx
Co-ordinator of MD Unit : Frédérique Meulders - tel:+32 2 524.83.22
Federal Agency for Medicines and Health Products Health Products Division
Place Victor Horta 40, boîte 40, B - 1060, Brussels, fax:+32 2 524.81.20
E-mail: meddev@fagg.be - Web site - 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 of Clinical Biology
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: Dr. Lyubomir Dimitrov, Rumena Kamburova, Todor Darakchiev
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia,

tel:+359 2 890 35 11, fax:+359 2 890 34 34
E-mail: lyubomir.dimitrov@bda.bg, roumena.kambourova@bda.bg, darakchiev@bda.bg - Web site

Ceska Republika / Czech Republic

Danuše Drahotová, Pavel Sroub
Ministry of Health
Palackého náměstí 4, CZ - 12801 Prague 2,

tel:+420 224 972 735, +420 224 972 738, fax: +420 224 916 002,
E-mail: danuse.drahotova@mzcr.cz, pavel.sroub@mzcr.cz -  Web site

Danmark / Denmark

Ellen Jespersen, Hans-Kristian Andersen
Danish Medicines Agency Inspection & Medical Devices
Axel Heides Gade 1, DK - 2300 - Kobenhavn,

tel:+45 44 88 97 75, fax:+45 44 88 95 99
E-mail: med-udstyr@dkma.dk, Web sites: www.medicinskudstyr.dk, www.medicaldevices.dk

Deutschland / Germany

AIMDD, MDD, IVDMD Legislation
Wilfried Reischl - tel:+ 49 228 941-1180, Dr. Matthias Neumann - tel:+49 228 941-2636
Federal Ministry of Health
Am Propsthof 78a, D - 53123 Bonn, fax:+ 49 228 941-4946
E-mail: medizinprodukte@bmgs.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. Dirk Wetzel - tel:+49 228 207 5235
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

Dr. Andrei Knuut - tel:+372 737 44 99, fax:+372 737 44 08
Health Board, Medical Devices Department
1a Põllu st., EE - Tartu 50303,
E-mail: MSO@terviseamet.ee - Web site

Ireland / Eire

Ann O'Connor - tel:+353-1-6764971, fax:+353-1-6344033
Irish Medicines Board
Kevin O’Malley House, Medical Devices Department, Earlsfort Centre, Earlsfort Terrace, IE - Dublin 2
E-mail: medicaldevices@imb.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: +34918225261, fax: +34918225289
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: sgps@aemps.es, Web sites www.msc.es www.aemps.es

France

Dr. Jean-Claude Ghislain - tel:+33 1 55 87 4271 fax:+33 1 55 87 37 42
Agence française de sécurité sanitaire des produits de santé (AFSSAPS)
143-147 boulevard Anatole France,  FR - 93285 Saint Denis Cedex
E-mail: dedim.ugsv@afssaps.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.Giovanna Nisticò - tel:+39 06 5994 3809, fax:+39 06 5994 3266
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: an.donato@sanita.it, g.nistico@sanita.it Web site

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 Web site

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 Web site

Lietuva / Lithuania

Director: Prof. Juozas Galdikas - 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
Zalgirio str. 92, LT- 09303 Vilnius
E-mail: juozas.galdikas@vaspvt.gov.lt, vaspvt@vaspvt.gov.lt - Web site

Luxembourg

Dr Gérard Scharll - tel:+352 478 56 34, fax:+352 26 20 32 96
Ministère de la Santé, Direction de la Santé
Villa Louvigny - allée Marconi, L - 2120 Luxembourg
E-mail: gerard.scharll@ms.etat.lu - Web site

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: p.bunyitai@eekh.hu, amf@eekh.hu Web site

Nederland / Netherlands

Notification/Registration
Joan Deckers PhD - tel:+31 70 340 5200, fax:+31 70 340 7426
CIBG Farmatec-BMC
Postal address: PO box 16114, NL - 2500 BC The Hague,

Visitors address: Wijnhaven 16, NL - 2511 GA Den Haag
E-mail: Medische_hulpmiddelen@minvws.n - 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
Joanna Kilkowska - tel:+48 22 492 11 70, Andrzej Karczewicz - tel:+48 22 4921190
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, andrzej.karczewicz@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

Ana Tanase - tel:+40 21 307 25 81, fax:+40 21 307 25 85
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 510
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
Ptujska ulica 21, SI-1000 Ljubljana,
E-mail: meddev@jazmp.si, romana.kajdiz@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: 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. Lars Johansson
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

Steve Owen - tel:+44 203 080 7184, fax:+44 203 118 9808
Medicines & Healthcare products Regulatory Agency (MHRA)
Floor 5-M, Buckingham Palace Road - London SW1W 9SZ
E-mail: steve.owen@mhra.gsi.gov.uk - Web site

Norway / Norge

Ingeborg Hagerup-Jenssen, Bjørn Kristian Berge
Sosial- og helsedirektoratet Norwegian Directorate for Health and Social Affairs
P.O. Box 7000 ST. Olavplass, N - 0130 Oslo,

tel:+47 24 16 31 05, fax:+47 24 16 30 21,
E-mail: meddev-no@shdir.no - Web site

Iceland / Island

Anna Bjorg Aradottir - tel:+354 510 1900, fax:+354 510 1919
Directorate of Health
Austurstrond 5, IS - 170 Seltjarnarnes
E-mail: annabara@landlaeknir.is - Web site

Switzerland

AIMDD - MDD   Dr. Margit Widmann     
IVDMD  Dr. Andreas Schlegel
Swissmedic Medical Devices Division
Erlachstr. 8, CH -3000 Bern 9,

tel:+41 31 323 22 51, fax:+41 31 322 7646,

Web site
E-mail: margit.widmann@swissmedic.ch, andreas.schlegel@swissmedic.ch, materiovigilance@swissmedic.ch

Lichtenstein

R. Kieber, tel:+423 236 66 33, fax:+423 236 75 64
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: reto.kieber@ag.llv.li - Web site

Turkey

Bilgehan Karadayi, Olgun Sener, Mehtap Cakmak Barsbay
Ministry of Health
General Directorate of Pharmacy and Parmaceuticals Biomedical Engineering Department
Atatürk Bulvarı No: 657. Kat Sıhhiye 06343 Ankara/TURKEY,

tel:+90 312 3240248, fax:+90 312 3240378
E-mail: bilgehan.karadayi@saglik.gov.tr, olgun.sener@saglik.gov.tr, mehtap.cakmak@saglik.gov.tr - Web site