List of 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.beWeb site

IVDMD
Dr.Sc.Biol. Christel Van Campenhout
Dr. Anne Van Nerom, DVM
- tel:+32 2 642 55 40
Scientific Institute Public Health, Department Quality Medical Laboratories
J. Wytsmanstraat, 14, B-1050 Brussels, fax:+32 2 642 56 45
E-mail: Christel.VanCampenhout@wiv-isp.be, Anne.VanNerom@wiv-isp.beWeb site

 Bulgaria

Head of Department: Vessela Boudinova, Todor Darakchiev
Bulgarian Drug Agency Department Medical devices
8 Damyan Gruev Str., BG - 1303 Sofia, tel:+359 2 890 34 83, fax:+359 2 890 34 34
E-mail: vessela.boudinova@bda.bg, darakchiev@bda.bgWeb site

 Ceska Republika / Czech Republic

Karolina Pestova, 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.czWeb 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
E-mail: Suzana.ostarcevic@halmed.hr - Web site

 Danmark / Denmark

Kristine Rasmussen, 
Danish Health and Medicines Authority,
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
Rochusstrasse 1, D - 53123 Bonn, 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.deWeb 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.deWebsite

 Eesti / Estonia

Dr. Andrei Knuut - tel:+372 744 7499, fax:+372 744 7408
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.ieWeb 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: +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 http://www.aemps.gob.es/

 France

Dr. Jean-Claude Ghislain - tel:+33 1 55 87 4271 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: dedim.ugsv@ansm.sante.frWeb 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 Calamea - tel:+39 06 5994 2669, fax:+39 06 5994 3266
Ministry of Health, Department of Planning and Organisation of the National Health Service - Directorate General of Medical Devices, pharmaceutical services and safety in healthcare
via Giorgio Ribotta 5, IT - 00144 Roma,
E-mail: an.donato@sanita.it, p.calamea@sanita.it

 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

 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

 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.ltWeb 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.luWeb site

 Malta

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

 Magyarorszag / 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: p.bunyitai@eekh.hu, amd@eekh.hu

 Nederland / Netherlands

Notification/Registration
Front Office -
tel: +31 70 340 5487
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.nl Web site

Law Enforcement (a.o. vigilance and market surveillance)
Jan Moleveld, Laura de Vries
- tel:+31 88 120 5000, fax:+31 88 120 5001
Dutch Healthcare Inspectorate
Postal Address: P.O. Box 2680, NL - 3500BS Utrecht, Visitors address: St. Jacobsstraat 16, NL 3511 BS Utrecht
E-mail: meldpunt@igz.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.atWeb site  

 Polska / Poland

Competent Authority
Andrzej Karczewicz - tel:+48 22 492 11 90
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.plWeb 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.ptWeb 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

Igor Lipuscek - 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, igor.lipuscek@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: marek.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.fiWeb site

 Sverige / Sweden

DrHelena 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.seWeb site

 United Kingdom

Tracy Murray - tel:+44 203 080 6329, fax:+44 203 118 9808
Medicines & Healthcare products Regulatory Agency (MHRA)
Floor 5-M, Buckingham Palace Road - London SW1W 9SZ
E-mail: tracy.murray@mhra.gsi.gov.ukWeb 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.noWeb 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

Berndhard Bichsel 
Swissmedic, Swiss Agency for Therapeutic Products 
Hallerstrasse 7, CH -3012 Bern 7,
E-mail: medical.devices@swissmedic.ch - Web site

 Liechtenstein

Dr. Christina Zimmer, tel:+423 236 73 33, fax:+423 236 75 64
Amt für Gesundheit
Äulestrasse 51, Postfach 684, FL - 9490 Vaduz
E-mail: christina.zimmer@llv.li - info.ag@llv.li - Web site

 Turkey  

Hande TURAN, A.Volkan KELES - Tel: +90 312 2183072/73, Fax:+90 312 2183059
Ministry of Health
DG for Pharmaceuticals and Pharmacy
Department of Medical Device Services,
Market Surveillance Section
Mithatpasa Cad. No:3, Sihhiye 06434, Ankara/TÜRKIYE
E-mail: meddev.vigilance@iegm.gov.tr - Web site