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:

  • Reference MEDDEV 2.12/1 to determine the correct reporting timeline, which will depend on the severity of the incident.
  • Inform appropriate Competent Authorities that an incident has occurred.
  • Respond to questions from Competent Authorities regarding devices involved, time on the market and design changes.
  • Determine if a Field Safety Corrective Action (FSCA) and Field Safety Notice (FSN) are necessary and report to appropriate Competent Authorities.
  • Submit a Final Incident or FSCA Report to Competent Authorities.
  • Add vigilance reports, along with any correspondence with Competent Authorities, to your ISO 13485 or other quality system records.
  • Inform your Notified Body of any incidents or FSCAs unless your device is Class 1 self-certified.


    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]et.no

    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]