Legislation and requirements

Legislation, requirements and informative documents

Medical devices

Belgie / 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.besteve.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,

 

Bulgaria

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 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

 

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

 

Danmark / 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

 

Deutschland / 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

 

Ireland / 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

 

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 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

 

Italia / 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.ita.parisi@sanita.ita.misticoniconsorti@sanita.it

 

Kypros / 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

 

Latvija / 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

 

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
Jeruzalès str. 21, LT- 08420 Vilnius
E-mail: julius.tertelis@vaspvt.gov.ltvaspvt@vaspvt.gov.lt

 

Luxembourg

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

 

Malta

Ingrid Busuttil – tel: +356 23952230
Malta Competition and Consumer Affairs Authority
Mizzi House, National Road, Blata l-Bajda, HMR 9010, Malta
E-mail: medical.devices@mccaa.org.mtWeb site

 

Magyarorszag / Hungary

Peter Bunyitai – tel:+36 1 302 5060, fax:+36 1 269 1255
Health Registration and Training Centre, Department of Medical Devices
1051, Budapest, Zrínyi street 3, Hungary 
E-mail: vigilance@enkk.hu

 

Nederland / 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

 

Österreich / 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

 

Polska / 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

 

Romania

Margareta Mihalache – tel:+40 21 260 0158, fax:+40 21 222 8683
National Agency for Medicnes and Medical Devices
58, Sos. Nicolae Titulescu, sector 1, Bucharest
E-mail: mdevice@anm.romargaretamihalache@ms.ro – Web site

 

Slovenija / Slovenia

Marcia Elena Podboršek – 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.simarcia.podborsek@jazmp.si – Web site

 

Slovenska 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: 

 

Suomi / 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

 

Sverige / 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 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

 

Norway / 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

 

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

Swissmedic Medical Devices Division
Hallerstrasse 7, CH -3000 Bern 9
E-mail: clinicaltrials.devices@swissmedic.ch

Liechtenstein

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

 

Turkey

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

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