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 URL
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 URL
Czech Republic	Czech Office for Standards, Metrology and Testing Gorazdova 24, P.O.Box 49 CZ-12801 Prague 2 Mr Jaromír Jedlicka e-mail jedlicka@unmz.cz Fax +420-224-907-152 Phone +420-224-907-134 URL http://www.unmz.cz
Denmark	Ministry of Interior and Health Slotsholmsgade 10-12 DK-1216 Copenhagen K Mr Taruh Sekeroglu e-mail tse@sum.dk Fax +45-7226-9001 Phone +45-7226-9000 URL http://www.sum.dk
Estonia	Health Board Põllu 1a EE-50303 Tartu Mr Sulev Jaksman e-mail sulev.jaksman@terviseamet.ee Fax +372 744 7408 Phone +372 7447 7408 URL http://www.terviseamet.ee
Finland	National Agency for Medicines Inspectorate Mannerheimintie 103b SF-00301 Helsinki Mr Hannu Seitsonen e-mail hannu.seitsonen@nam.fi Fax +358-9-4733-4266 Phone +358-9-4733-4249 URL http://www.nam.fi
France	Agence francaise de Sécurité Sanitaire des Produits de santé 143-147 Bd Anatole France F-93285 Saint-Denis cedex Mr Francois Bruneaux e-mail francois.bruneaux@afssaps.sante.fr Fax +33-1-5587-4052 Phone +33-1-5587-40-06 URL http://www.afssaps.sante.fr
Germany	Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Abteilung Medizinprodukte Sebastianstrasse 189 D-53115 Bonn Mr Dr. Rainer Edelhäuser e-mail rainer.edelhaeuser@zlg.nrw.de Fax +49-228-97794-44 Phone +49-228-97794-12 URL http://www.zlg.de
Greece	Minister of Health and Social Solidarity National Organisation of Medicines Head, Evaluation Division 284 Mesoghion Ave GR-15562 Holargos Ms Dr. Vasiliki Revithi e-mail vrevithi@eof.gr Fax +30-2132040450 Phone +30-2132040407 URL http://www.eof.gr
Hungary	Office of Health Authorisation and Administrative Procedures Authority for Medical Devices Zrinyi u.3. H-1051 Budapest Mr György Ferenc Balázs e-mail balazs.gyorgy@eekh.hu Fax +36-1-269-1255 Phone +36-1-302-5060 URL http://www.eekh.hu
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	Irish Medicines Board Kevin O´Malley House Earlsfort Terrrace IRL-Dublin 2 Mr Dr. Niall MacAleenan e-mail niall.macaleenan@imb.ie Fax +353-1-676-7836 Phone +353-1-676-4971 URL http://www.medicaldevices.ie
Italy	Ministry of Health Directorate General of Drugs and medical Devices Office III - medical Devices Viale della Civilta Romana, 7 I-00144 Roma Mr Giuseppe Ruocco e-mail g.ruocco@sanita.it Fax +39-06-59943-380 Phone +39-06-59943-809 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	The Government of Liechtenstein Regierungsgebäude Accreditation Agency Städtle 49 LIE-POSTFACH 684 Vaduz Mail-administrating centre LIE e-mail info@rfl.llv.li Fax +432-236-65-97 Phone +423-236-61-11 URL http://www.rfl.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	Regulatory Affairs Directorate Malta Standards Authority Second Floor Evans Building Merchants Street M-Valletta VLT 1179 Mr David Pulis e-mail david.pulis@msa.org.mt Fax +356-21242-406 Phone +356-2395-2000 URL http://www.msa.org.mt
Netherlands	The Dutch Health Care Inspectorate P.O. Box 5837 2280 HV Rijswijk Mr L. W. Meinders e-Mail loket@igz.nl Fax +31-70-3723110 Phone +31-70-3723166 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 Ms Agnieszka Bukowska e-mail jednostkinotyfikowane@mz.gov.pl Fax +48-22-8314354 Phone URL
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 Ana Maria Tanase e-mail atanase@ms.ro Fax +40-21-307-2585 Phone +40-21-307-2581 URL http://www.ms.ro
Slovak Republic	Slovak Office of Standards, Metrology and Testing Department of Testing and Technical Standardization Stefanovicova 3 SK-81005 Bratislava Mr Martin Senčák e-mail martin.sencak@normoff.gov.sk Fax +42-12-5249-7887 Phone +42-12-5249-1147 URL http://www.normoff.sk
Slovenia	Agency for Medial Products and Medial Devices of the Republic of Slovenia Ptujska ulica 21 SLO-1000 Ljublijana Ms Dr Petra Marinko e-mail meddev@jazmp.si Fax +386-82000-557 Phone +386-82000-500 URL http://www.jazmp.si
Spain	Ministerio de sanidad y consumo 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@agemed.es Fax +34-91-82252-89 Phone +34-91-82252-61 URL http://www.agemed.es
Sweden	SWEDAC Styrelsen för ackreditering och teknisk kontroll Swedish Board for Accreditation and Conformity Assesment Box 2231 S-10315 Stockholm Mr Anders Hallberg e-mail anders.hallberg@swedac.se Fax +46-8-791-8929 Phone +46-8-406-8338 URL http://www.swedac.se
Switzerland	Swissmedic, Schweizerisches Heilmittelinstitut Swiss Agency for Therapeutic Products Marktkontrolle Hallerstraße 7 CH-3000 Bern 9 Mr Peter Studer e-mail peter.studer@swissmedic.ch Fax +41-31-322-7646 Phone +41-31-322-9457 URL http://www.swissmedic.ch

United Kingdom

Medicines and Healthcare Products Regulatory Agency
1 Nine Elms Lane
UK- London SW8 5NQ
Mr Rob Higgins
e-mail rob.higgins@mhra.gsi.gov.uk
Fax +44-207-084-3112
Phone +44-207-084-3185
URL http://www.mhra.gov.uk