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българскиMedical Device Vigilance and Incident Reporting in Europe
What is medical device vigilance and adverse event reporting?
The European Medical Devices Regulatory (MDR 2017/745) state that medical device manufacturers are legally required to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities. However, the “when, what, and to whom” aspect of EU incident reporting often confuses regulatory professionals. Companies that fail to correctly report incidents could face severe consequences. Ignorance is not an acceptable excuse for not reporting incidents, so RA professionals need to be proactive.
When are EU vigilance reports required?
The term “vigilance report” encompasses Incident Reports and Field Safety Corrective Action (FSCA) reports. According to MEDDEV 2.12/1, an incident report must be filed if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death or serious injury, or may lead to death or serious deterioration in state of health if it were to recur. The incident must be reported to the Competent Authority (CA) of the member state where the incident occurred. If a manufacturer takes an action to reduce the risk of death or serious deterioration in health, such as a recall, a Field Safety Corrective Action (FSCA) report must be distributed to CAs in the member states where the device is being marketed as well as the CA where the manufacturer or their AR is located. Europe’s new Medical Device Regulation (MDR) addresses specific timelines for FSCA reports. Download our free, in-depth white paper for details about MDR changes related to vigilance reporting: Understanding Europe’s New Medical Device Regulation.
EU medical device adverse incident and FSCA reporting process
These are the basic steps to reporting an incident in Europe:
CONTACT POINT
België / Belgique / Belgien / Belgium MDD AIMDD – IVDMD Head of Vigilance Division: Th. Roisin MDD AIMDD Vigilance: C. Driesmans tel: +32 2 528 4418 IVDMD Vigilance: J. Poels tel: +32 2 528 4449 E-mail: [email protected] FAMHP- Federal Agency for Medicines and Health Products Place Victor Horta 40, box 40, B – 1060, Brussels, fax:+32 2 528 4120 Bulgaria Executive Director of BDA: Bogdan Kirilov, M.Pharm. Head of Division ‘Medical devices’: Todor Darakchiev Bulgarian Drug Agency 8 Damyan Gruev Str., BG – 1303 Sofia, tel:+359 2 890 34 83, fax:+359 2 890 34 34 E-mail: [email protected], [email protected] Ceska Republika / Czech Republic Ivana Justová State Institute for Drug Control Šrobárova 48, 100 41 Prague 10, Czech Republic, tel: +420 272 185 794, fax: +420 272 185 764 E-mail: [email protected] , [email protected] Hrvatska / Croatia Krunoslav Kranjcec, Agency for Medicinal products and medical devices Ksaverska cesta 4, 10 000 Zagreb, tel: +385 1 4884 327, fax: +381 1 4884 110 E-mail: [email protected], Krunoslav.kranjcec @halmed.hr Danmark / Denmark Danish Medicines Agency Axel Heides Gade 1, DK – 2300 – Kobenhavn, tel:+45 44 88 9595, fax:+45 44 88 9599 E-mail: [email protected], Web sites: www.medicinskudstyr.dk Deutschland / Germany AIMDD, MDD – Dr. Ekkehard Stößlein – tel:+49 228 207 5384 IVDMD – Prof. 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: [email protected] IVDMD 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: [email protected] Eesti / Estonia Sofia Ratusnaja – tel:+372 744 7425 Health Board, Medical Devices Department 1a Põllu st., EE – Tartu 50303 E-mail: [email protected] Ireland / Eire Health Products Regulatory Authority Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, IE – Dublin 2 E-mail: [email protected] Ellada / Greece Eleni Papaioannou, MD – tel:+30 213 20 40542, fax:+30 210 65 49585 E-mail: [email protected] National Organization for Medicines 284 Mesogion Ave, GR- 15562 Holargos, Athens España / Spain Carmen Abad Carmen Valls – tel: +34 91 822 5255, fax: +34 91 822 5289 Agencia Espaňola de Medicamentos y Productos Sanitarios C/ Campezo 1, Edificio 8, ES – 28022 Madrid E-mail: [email protected] France Emilie Alliez – tel:+33 1 55 87 33 46, fax:+33 1 55 87 37 02 Agence nationale de sécurité du médicament et des produits de santé (ANSM) 143-147 boulevard Anatole France, FR – 93285 Saint Denis Cedex E-mails: Exclusively for correspondence between authorities:[email protected] Other purposes: [email protected] Italia / Italy Vigilance on Medical Devices Head of Unit 5 – Dr.ssa Lucia Lispi – tel:+39 06 5994 2055 E-mail: [email protected], [email protected], [email protected] MDD AIMDD Vigilance – Dr.ssa Antonella Campanale – Dr.ssa Daniela Minella tel: +39 06 5994 3038, +39 06 5994 3069 E-mail: [email protected], [email protected], [email protected]; [email protected] Head of Unit 4 – Dr.ssa Antonella Colliardo – tel:+39 06 59943968.IVDMD Vigilance – Dr.ssa Maria Gabriella Cividino – Dr.ssa Maria Elena Russo tel: +39 06 59943785, +39 06 59942516 E-mail: [email protected], [email protected]; [email protected]; [email protected] Ministry of Health, Directorate General of Medical Devices and Pharmaceutical Services Via Giorgio Ribotta 5, IT – 00144 Roma Kypros / Kibris / Cyprus Ioannis Argyropoulos – tel: +357 22 605785 Cyprus Medical Devices Competent Authority Prodromou 1 & Chilonos 17 Corner, CY – 1449 Nicosia, fax:+357 22 468427 E-mail: [email protected] Latvija / Latvia Medical Device Evaluation Department – tel: +371 67 078 466, tel: +371 67078466 State Agency of Medicines, 15 Jersikas street, LV – 1003 Riga E-mail: [email protected] Lietuva / Lithuania Director: Nora Ribokiene – 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 Jeruzales str. 21, LT-08420 Vilnius E-mail: [email protected] Luxembourg Ministère de la Santé, Direction de la Santé – tel : +352 247 85612 Villa Louvigny – allée Marconi, L – 2120 Luxembourg E-mail: [email protected] Malta Malta Medicines Authority – Medical Devices Unit Medicines Authority Sir Temi Żammit Buildings, Malta Life Sciences Park San Ġwann SĠN 3000, Malta Tel : +356 2343 9000 E-mail : [email protected] Magyarorszag / Hungary Kornel Szerdi dr.- tel:+36 1 886 9329, fax:+36 1 269 1255 Health Registration and Training Centre, Department of Medical Devices 1051, Budapest, Zrínyi street 3, Hungary E-mail: [email protected] Nederland / Netherlands Sietske Eerens, Esther Klinckenberg – tel:+31 88 120 5000, fax:+31 88 120 5001 Dutch Health and Youth Care Inspectorate, IGJ Information Office (Meldpunt) Visitors address: Stadsplateau 1 | 3521 AZ | Utrecht, postal address: Postbus 2518 | 6401 DA | Heerlen E-mail: [email protected] Österreich / Austria Federal Office for Safety in Healthcare – (BASG) Bundesamt für Sicherheit im Gesundheitswesen Institute for Surveillance, Department Medical Devices Surveillance Traisengasse 5, A-1200 Vienna, fax: +43 50555 36409 E-mail: [email protected] Polska / Poland Competent Authority Andrzej Karczewicz – tel:+48 22 492 11 90, Beata Koziozemska – tel: +48 22 492 11 68 Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C, 02-222 Warsaw, fax:+48 22 492 11 99 E-mail: [email protected] Portugal – Vigilance Raquel Alves – tel: + 351 21 798 7297, tel:+351 21 798 7145, fax:+351 211 117 559 Infarmed – National Authority of Medicines and Health Products, IP Unidade de Vigilância de Produtos de Saúde da Direção de Produtos de Saúde Parque da Saúde de Lisboa, Av. do Brasil, nº 53, PT – 1749-004 Lisboa E-mail: [email protected] Romania Oana Arsenescu Georgeta Herta tel: +40 21.222.86.52, +40 21 260.01.58, +40 21 260.01.59 fax: +40 21.222.86.83 National Agency for Medicines and Medical Devices of Romania 58, Sos. Nicolae Titulescu, sector 1, Bucharest E-mail: [email protected], [email protected] – Web site Slovenija / Slovenia JAZMP – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Slovenčeva ulica 22, SI – 1000 Ljubljana – – tel: +386 8 2000 500 E-mail: [email protected], [email protected] Slovenska Republika / Slovakia Darina Kaminská – tel:+421 2 50701215, State Institute for Drug Control, Medical Devices Section Kvetna 11, SK – 825 08 Bratislava E-mail: [email protected] Suomi / Finland Finnish Medicines Agency Fimea Medical Devices Unit Mannerheimintie 166, P.O. box 55, FI-00034 FIMEA, FINLAND, tel:+358 29 522 3602 E-mail: [email protected], [email protected] Sverige / Sweden Swedish Medical Products Agency ‘Läkemedelsverket’ Department of Medical Devices Box 26, SE-751 03 Uppsala, – tel:+46 18 174600, E-mail: [email protected] Norway / Norge AIMDD, MDD IVDMD – – Raymond Ludvigsen / Bjørn Kristian Berge Statens legemiddelverk/ Norwegian Medicines Agency Postboks 6167 Etterstad, N-0602 Oslo, tel:+47 22 89 77 00 E-mail: [email protected] Iceland / Island Haukur Eggertsson – tel:+354 520 2100, fax:+354 561 2170 Icelandic Medicines Agency Vínlandsleið 14, IS-113 Reykjavík E-mail: [email protected] Liechtenstein Martin Stricker, tel:+423 236 73 36 Office of Public Health Äulestrasse 51, Postfach 684, FL – 9490 Vaduz E-mail: [email protected] Turkey The Ministry Of Health, Turkish Medicine and Medical Device Agency Vice Presidency of Inspectorate, Medical Device Vigilance Unit Söğütözü Mahallesi 2176. Sokak No:5 P.K. 06520 Çankaya Ankara/ TURKEY E-mail: [email protected]