NBOG National Contact Points

In order to encourage better communication Member States established a communication protocol (see ANNEX 1 to Section 2 of the Designating Authorities Handbook) and national contact points.

The aims of the communication protocol are to encourage examples of possible poor performance to be passed to the appropriate Member State/Designating Authority for investigation.

In addition, the named individuals listed below can be used as a contact point by anyone wishing to obtain information on designation and control of Notified Bodies in individual countries.

Austria







 
Bundesministerium für Gesundheit, Familie und Jugend
Abteilung III/A/2
Radetzkystraße 2
A-1031 Wien
Mr Dr. Martin Renhardt
e-mail martin.renhardt@bmgfj.gv.at
Fax +43-1-711004-1590
Phone +43-1-711004-487
URL http://www.bmgfj.gv.at
Belgium









 
Federal Agency for Medicines and Health Products
AFMPS/FAGG
Health Products Division
Eurostation II
Place Victor Horta 40 b40
B-1060 Brussels
Ms Frédérique Meulders
e-mail meddev@fagg.be
Fax +32-2-524-8120
Phone +32-2-524-8322
URL http://www.fagg.be
Bulgaria






 
State Agency for Metrological and Technical Surveillance
"Designation of Conformity Assessment Bodies" Directorate
21."6-th Septemvri",Str.
BG-1000 Sofia
Ms Mariana Tsaneva
e-mail comfass@mail.orbitel.bg
Fax +359-2-986-17-07
Phone +359-2-981-00-89
Cyprus





 
Cyprus medical Devices Competent Authority
Prodromou 1 & Chilonos 17 Corner
CY-1449 Nicosia
Ms Maria Athanasiadou
e-mail cymda@mphs.moh.gov.cy
Fax +35-722375120
Phone +35-722867185
Czech Republic





 
Czech Office for Standards, Metrology and Testing
Biskupský dvůr 1148/5
CZ-11000 Prague 1
Ms Pavla Justová
e-mail justova@unmz.cz
Phone +420-221-802-162
URL http://www.unmz.cz
Denmark





 
Danish Medicines Agency
Axel Heides Gade 1
DK-2300 Copenhagen S
Ms Neel Larsen
e-mail med-udstyr@dkma.dk
Phone +45-44889542
URL http://laegemiddelstyrelsen.dk
Estonia





 
Health Board
Põllu 1a
EE-50303 Tartu
Ms Sofia Ratušnaja
e-mail mso@terviseamet.ee
Phone +372 744 7425
URL http://www.terviseamet.ee/en/medical-devices
Finland






 
National Supervisory Authority for Welfare and Health
Lintulahdenkuja 4
SF-00530 Helsinki
Mr Heikki Mattlar
e-mail heikki.mattlar@valvira.fi
Fax +358-295-209-702 
Phone +385-295-209-506
URL http://www.valvira.fi
France







 
Agence Nationale de sécurité du médicament et des produits de santé
(National Drug and Health Products Safety Agency)
143-147 Bd Anatole France
F-93285 Saint-Denis cedex
Mrs Sophie Roques
e-mail Sophie.ROQUES@ansm.sante.fr
Fax +33-1-5587-4052
Phone +33-1-5587-3977
URL http://www.ansm.sante.fr
Germany






 
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten
Heinrich-Böll-Ring 10
D-53119 Bonn
Mr Dr. Rainer Edelhäuser
e-mail rainer.edelhaeuser@zlg.nrw.de
Fax +49-228-97794-44 
Phone +49-228-97794-10
URL https://www.zlg.de
Greece








 
National Organisation for Medicines (EOF)
Manufacturing and Marketing Surveillance Division
Inspection SectionInspection Section
284 Mesogeion Avenue
GR-15562 Holargos
Mr Dr. Haralabos Katsoulas
e-mail hkatsoulas@eof.gr
Fax +30-2132040500
Phone +30-2132040280
URL http://www.eof.gr
Hungary






 

National Institute of Medicines and Nutrition (OGYÉI)

Department of Medical Devices
Zrínyi u. 3
H-1051 Budapest

Mail: Budapest 1372 P.O. Box: 450. Hungary
Mr Péter Bunyitai
e-mail amd@ogyei.gov.hu
Phone +36-1-886-9329
URL https://www.ogyei.gov.hu/orvostechnika/

Iceland






 
Directorate of Health
Austurströnd 5
IS-170 Seltjarnarnes
Ms Anna Björg Aradottir
e-mail annabara@landlaeknir.is
Fax +354-510-1900
Phone +354-510-1900
URL http://www.landlaeknir.is
Ireland







 
Health Products Regulatory Authority (HPRA)
Kevin O´Malley House
Earlsfort Centre, Earlsfort Terrrace
IRL-Dublin 2
Mr Dr. Niall MacAleenan
e-mail niall.macaleenan@hpra.ie
Fax +353-1-676-7836 
Phone +353-1-676-4971 
URL http://www.hpra.ie
Italy








 
Ministry of Health
Directorate General of medical devices, pharmaceutical services and safety in healthcare Office III - medical Devices
Via G. Ribotta 5Via G. Ribotta 5
I-00144 Roma
Mrs Antonella Colliardo
e-mail a.colliardo@sanita.it
Fax +39-06-5994-2523 
Phone +39-06-5994-3968
URL http://www.ministerosalute.it/dispositivi/dispomed.jsp
Latvia







 
Medical Devices Board for Latvia
Health Statistics and Medical Technologies State Agency, MoH Latvia
12/22 Duntes street
LV-1005 Riga
Mr Alnis Dambergs
e-mail alnis.dambergs@vsmtva.gov.lv
Fax +371-7-50-15-91 
Phone +371-67-50-15-93 
URL http://www.vsmtva.gov.lv
Liechtenstein








 
Amt für Volkswirtschaft
Technische Prüf-, Mess- und Normenstelle (TPMN)
Postfach 684
Städtle 49
LIE-9490 Vaduz
Mr Thomas Näf
e-mail tpmn.avw@llv.li
Fax +423-236-68-89
Phone +423-236-69-03
URL http://www.avw.llv.li
Lithuania







 
State Health Care Accrediation Agency
Under the Ministry of Health of the Republic of Lithuania
Zalgirio st. 92
LT-09303 Vilnius
Ms Jolanta Karavackaite
e-mail vaspvt@vaspvt.gov.lt
Fax +370-5-2127310
Phone +370-5-2615177
URL http://www.vaspvt.gov.lt
Luxembourg






 
Ministère de la Santé
Villa Louvigny - alleé Marconi
L-2120 Luxembourg
Mr Gerard Scharll
e-mail gerard.scharll@ms.etat.lu
Fax +352-26-20-32-96 
Phone +352-24-78-56-34 
URL http://www.etat.lu/MS/DIV_MECU/dispositifs.htm
Malta










 
Malta Competition and Consumer Affairs Authority
Technical Regulations Division
Mizzi House
National Road
Blata l-Bajda, Hamrun
HMR9010
Malta
Mr Tristan Camilleri
e-mail tristan-charles.camilleri@mccaa.org.mt
Fax +356-2124-2406
Phone +356-2395-2210
URL http://www.mccaa.org.mt
Netherlands






 
Dutch Healthcare Inspectorate
P.O. Box 2680
3500 BS Utrecht
Mr L. W. Meinders
e-Mail meldpunt@igz.nl
Fax +31-88-12050001
Phone +31-88-120500
URL http://www.igz.nl
Norway







 
Directorate of Health
P.O. Box 7000
St. Olavs plass
N-0130 Oslo
Ms Ingeborg Hagerup-Jenssen
e-mail meddev-no@helsedir.no
Fax +47-24-1630-21
Phone +47-24-1631-05
URL http://www.helsedirektoratet.no
Poland






 
Ministry of Health
Drug Policy and Pharmacy Department
Medical Device Division
15, Miodowa Street
PL-00-952 Warsaw
Mrs Agnieszka Ostrowska
e-mail jednostkinotyfikowane@mz.gov.pl
Fax +48-22-8314354

Portugal

 

 

 

 

 

 

 

 

 

INFARMED, I.P.
National Authority of Medicines and Health Products
Paryue de Saude de Lisboa
Av. do Brazil, no 53
P-1749-004 Lisboa
Ms Judite Neves
e-mail judite.neves@infarmed.pt
Fax +351-21-79872-81 
Phone +351-21-79872-35 
URL http://www.infarmed.pt

Romania

 

 

 

 

 

 

 

Ministry of Health
1-3 Cristian Popisteanu ST. Sector 1
R-010024 Bucharest
Ms Margareta Mihalache
e-mail mdevice@ms.ro
Fax +40-21-307-2585
Phone +40-21-307-2689
URL http://www.ms.ro

Slovak Republic

 

 

 

 

 

 

 

 

Slovak Office of Standards, Metrology and Testing
Department of Testing
Stefanovicova 3, P.O. BOX 76
SK-81005 Bratislava
Mrs Monika Laurovičová
e-mail monika.laurovicova@normoff.gov.sk
Fax +421-2-5249-7887
Phone +421-2-5249-1147
URL http://www.unms.sk

Slovenia

 

 

 

 

 

 

 

Agency for Medial Products and Medial Devices of the Republic of Slovenia
Slovenčeva ulica 22
SLO-1000 Ljublijana
Mrs Marcia Elena Podboršek
e-mail marcia.podborsek@jazmp.si
Fax +386-82000-510
Phone +386-82000-500
URL http://www.jazmp.si

Spain

 

 

 

 

 

 

 

 

 

Ministerio de sanidad, servicios sociales e igualdad
Agencia Española de Medicamentos y Productos Sanitarios
Parque Empresarial Las Mercedes
Edificio 8.C/ Campezo 1.
E-28022 Madrid
Ms Carmen Abad
e-mail sgps@aemps.es
Fax +34-91-82252-89
Phone +34-91-82254-99
URL http://www.aemps.gob.es

Sweden

 

 

 

 

 

 

 

 

SWEDAC
Styrelsen för ackreditering och teknisk kontroll
Swedish Board for Accreditation and Conformity Assesment
Box 878
SE-50115 Borås
Ms Stina Nylén
e-mail stina.nylen@swedac.se
Phone +46-33-177741
URL http://www.swedac.se
Switzerland








 
Swissmedic, Schweizerisches Heilmittelinstitut
Swiss Agency for Therapeutic Products
Marktkontrolle
Hallerstraße 7
CH-3000 Bern 9
Mr Dr. Michael Köhli
e-mail medical.devices@swissmedic.ch
Fax +41-58-462-76-46
Phone + 41-58-463-22-51
URL http://www.swissmedic.ch

Turkey

 

 

 

 

 

 

 

 

Republic of Turkey Ministry of Health
Turkish Medicines and Medical Devices Agency
Vice Presidency of Medical Devices and Cosmetics

Department of Medical Devices Notified Body and Clinical Trials

Section of Notified Body

Söğütözü Mahallesi 2176. Sokak No:5 Kat:6

TR-06520 Çankaya / Ankara

Mr Fatih Topuz
e-mail md.nb@titck.gov.tr
Fax + 90312 218-3552
Phone +90312 218-3058/3069
URL http://www.titck.gov.tr

United Kingdom

 

 

 

 

 

 

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
UK- London SW1W 9SZ
Mr Rob Higgins
e-mail rob.higgins@mhra.gsi.gov.uk
Phone +44-20-3080-7185
URL http://www.mhra.gov.uk

Australia

 

 

 

 

 

 

 

Therapeutic Goods Administration (TGA)
Marketing Authorisation Group
PO Box 100P
Woden ACT 2606
Australia
Ms Andrea Kunca
e-mail andrea.kunca@tga.gov.au
URL http://tga.gov.au