Competent authorities and medical devices registration
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With MDR 2017/745, is it still necessary to register in the European countries in which you wish to sell?
Regulation (EU) 2017/745, also known as MDR, explicitly mentions registration with the competent authorities. In Article 31, entitled "Registration of manufacturers, agents and importers", it is stipulated that manufacturers, agents and importers must transmit to the electronic system referred to in Article 30 the information necessary for their registration before placing on the market for a device other than a custom-made device. This electronic system is known as EUDAMED. If the conformity assessment procedure requires the intervention of a notified body, the information must be transmitted to EUDAMED before submitting an application to the notified body.
Ultimately EUDAMED will make it possible to avoid registration of medical devices with the competent authorities of each country, as was the case under MDD. However, to date the EUDAMED database is not fully operational, certain countries such as Belgium, Italy, Spain or Portugal require registration directly with their competent authority.
In the table below, you will find the list of competent authorities by country, as well as their contact details.
Do you want to know which countries you still need to register in? Contact us!
Country | Flag | Name and Address |
Belgique / Belgium |
| MDR - IVDR FAMHP - Federal Agency for Medicines and Health Products Avenue Galilée - Galileelaan 5/03, 1210 Brussels, fax:+32 2 528 4120 E-mail: welcome@fagg-afmps.be |
Bulgarie / Bulgaria |
| MDR - IVDR Bulgarian Drug Agency 8 Damyan Gruev Str., BG - 1303 Sofia E-mail: bda@bda.bg |
République Tchèque / Czech Republic |
| MDR - IVDR State Institute for Drug Control, Medical Devices Branch Šrobárova 48, CZ – 100 41 Prague 10 E-mail: medicaldevices@sukl.cz |
Croatie / Croatia |
| MDR - IVDR Agency for Medicinal Products and Medical Devices Ksaverska cesta 4, 10 000 Zagreb E-mail: halmed@halmed.hr http://www.halmed.hr/?ln=en |
Danemark / Denmark |
| MDR - IVDR Danish Medicines Agency Pharmacovigilance and Medical Devices Axel Heides Gade 1, DK - 2300 - Kobenhavn E-mail: med-udstyr@dkma.dk |
Allemagne / Germany |
| MDR-IVDR Legislation Federal Ministry of Health Friedrichstr. 108 - 10117 Berlin, fax:+ 49 228 941-4946 E-mail: medizinprodukte@bmg.bund.de http://www.bmg.bund.de/ministerium/english-version.html Authority responsible for notified bodies Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Heinrich-Böll-Ring 10, 53119 Bonn, E-mail: zlg@zlg.nrw.de MDR - IVDR Federal Institute for Drugs and Medical Devices Kurt Georg Kiesinger Allee 3, D - 53175 Bonn, E-mail: medizinprodukte@bfarm.de http://www.bfarm.de/cln_103/DE/Home/home_node.html IVDR Paul Ehrlich Institute, Section Pharmacovigilance 2 Paul-Ehrlich-Strasse 51-59, D - 63225 Langen, E-mail: pharmacovigilance2@pei.de |
Estonie / Estonia |
| MDR - IVDR Health Board, Medical Devices Department 1a Põllu st., EE - Tartu 50303 E-mail: MSO@terviseamet.ee |
Irlande / Ireland |
| MDR - IVDR Health Products Regulatory Authority Kevin O’Malley House, Medical Devices Department, Earlsfort Centre, Earlsfort Terrace, IE - Dublin D02 XP77 E-mail: devices@hpra.ie |
Grèce / Greece |
| MDR - IVDR National Organization for Medicines 284 Mesogion Ave, GR- 15562 Holargos, Athens E-mail: medicaldevices@eof.gr |
Espagne / Spain |
| MDR - IVDR Agencia Espaňola de Medicamentos y Productos Sanitarios C/ Campezo 1, Edificio 8, ES - 28022 Madrid E-mail: sgps@aemps.es |
France |
| MDR - IVDR Agence Nationale de Sécurité du Médicament et des Produits de Santé ANSM 143-147 boulevard Anatole France, FR - 93285 Saint Denis Cedex E-mail: dmcdiv@ansm.sante.fr |
Italie / Italy |
| MDR - IVDR Ministry of Health Directorate General of Medical Devices and Pharmaceutical Services via Giorgio Ribotta 5, IT - 00144 Roma E-mail: segr.dgfdm@sanita.it |
Chypre / Cyprus |
| MDR - IVDR Cyprus Medical Devices Competent Authority Prodromou 1 & Chilonos 17 Corner, CY - 1449 Nicosia E-mail: cymda@mphs.moh.gov.cy https://www.moh.gov.cy/moh/mphs/mphs.nsf/All/A82FE3D75F4BF2CAC225850A0036075A?OpenDocument |
Lettonie / Latvia |
| MDR - IVDR Medical Device Evaluation Department State Agency of Medicines 15 Jersikas street, LV - 1003 Riga E-mail: info@zva.gov.lv |
Lithuanie / Lithuania |
| MDR - IVDR The State Health Care Accreditation Agency under the Ministry of Health of the Republic of LithuaniaJeruzales str. 21, LT-08420 Vilnius E-mail: vaspvt@vaspvt.gov.lt |
Luxembourg |
| MDR - IVDR Ministry of Health 1, rue Charles Darwin L-1433 Luxembourg E-mail : meddevices@ms.etat.lu |
Malte / Malta |
| MDR - IVDR Malta Medicines Authority - Medical Devices Unit Sir Temi Żammit Buildings, Malta Life Sciences Park San Ġwann SĠN 3000, Malta E-mail : devices.medicinesauthority@gov.mt |
Hongrie / Hungary |
| National Institute of Pharmacy and Nutrition 1051, Budapest, Zrínyi street 3, Hungary E-mail: amd.vig@ogyei.gov.hu |
Pays-Bas / Netherlands |
| Notification & Registration Ministry of Health, Welfare and Sports CIBG Farmatec Postal address: PO box 16114, NL - 2500 BC The Hague, Visitors address: Rijnstraat 50, NL – 2515 XP Den Haag E-mail: medische_hulpmiddelen@minvws.nl https://www.farmatec.nl/medische-hulpmiddelen Market Surveillance & Vigilance Dutch Health and Youth Care Inspectorate (IGJ) Visitor’s address: Stadsplateau 1, 3521 AZ Utrecht, Postal address: Postbus 2518, 6401 DA Heerlen E-mail: meldpunt@igj.nl Notification of clinical investigations (MDR) and performance studies (IVDR) Central Committee on Research Involving Human Subjects (CCMO) Postal address: P.O. Box 16302, 2500 BH Den Haag E-mail: devices@ccmo.nl |
Autriche / Austria |
| MDR-IVDR Austrian Federal Office for Safety in Health Care (BASG) Traisengasse 5, 1200 Wien E-mail: medizinprodukte@basg.gv.at |
Pologne / Poland |
| MDR-IVDR Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw E-mail: incydenty@urpl.gov.pl |
Portugal |
| MDR-IVDR Infarmed - National Authority of Medicines and Health Products Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT - 1749-004 Lisboa E-mail: daps@infarmed.pt http://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos |
Roumanie / Romania |
| MDR-IVDR National Agency for Medicines and Medical Devices of Romania 58, Sos. Nicolae Titulescu, sector 1, Bucharest E-mail: mdevice@anm.ro |
Slovenie / Slovenia |
| MDR-IVDR Agency for Medicinal Products and Medical Devices of the Republic of Slovenia JAZMP Slovenčeva ulica 22, 1000 Ljubljana E-mail: meddev@jazmp.si |
Slovaquie / Slovakia |
| MDR-IVDR State Institute for Drug Control, Medical Devices Section Kvetna 11, SK - 825 08 Bratislava E-mail: sukl@sukl.sk |
Finlande / Finland |
| MDR-IVDR Finnish Medicines Agency Fimea Medical Devices Unit Mannerheimintie 166, P.O. Box 55, FI-00034 FIMEA |
Suède / Sweden |
| MDR-IVDR Swedish Medical Products Agency´ 'Läkemedelsverket' Department of Medical Devices Box 26, SE-751 03 Uppsala E-mail: registrator@lakemedelsverket.se |
Norvège / Norway |
| MDR-IVDR Statens legemiddelverk/ Norwegian Medicines Agency Postboks 6167 Etterstad, N-0602 Oslo E-mail: Meddev-no@noma.no |
Islande / Island |
| MDR-IVDR Icelandic Medicines Agency Vínlandsleið 14, IS-113 Reykjavík E-mail: ima@ima.is |
Liechtenstein |
| MDR-IVDR Office of Public Health Äulestrasse 51, Postfach 684, FL - 9490 Vaduz E-mail: medical.devices@llv.li |
Turquie / Türkiye |
| MDR-IVDR Turkish Medicines and Medical Devices Agency (TITCK) Ministry of Health Turkish Medicines and Medical Devices Agency Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara E-mail: md.ivd@titck.gov.tr |
We are at your service
European Regulation for Medical Devices MDR 2017/745 have added new requested requirements and these requirements form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).
CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR dossiers in their entirety
🔗 Do you want to know which countries you still need to register in? Contact us and find out how we can help you.