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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. Jo Campbell

    Company name change and product labelling

    Jo Campbell, Oct 9, 2015
    Replies:
    2
    Views:
    1,023
    Jo Campbell
    Oct 13, 2015
  2. Amy G

    Article 12 Procedure Pack Labelling Requirements

    Amy G, Oct 2, 2018
    Replies:
    1
    Views:
    2,157
    Stephen1985
    Jul 26, 2021
  3. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    1
    Views:
    1,822
    Marcus Emne
    Apr 8, 2021
  4. Kolleen Marie Tener

    Procedure for EU MDR Clinical Investigation

    Kolleen Marie Tener, Aug 26, 2020
    Replies:
    1
    Views:
    1,539
    yodon
    Aug 27, 2020
  5. Amy G

    Electronic Signatures

    Amy G, Oct 19, 2018
    Replies:
    1
    Views:
    805
    yodon
    Oct 19, 2018
  6. emmamartsolf

    EU REACH compliance

    emmamartsolf, Jun 27, 2017
    Replies:
    1
    Views:
    939
    johnnymo77
    Jun 27, 2017
  7. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    1,206
    Vintage Goose
    Dec 16, 2016
  8. khamec

    annex Za (Risk assessment)

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,071
    yodon
    Jun 13, 2016
  9. khamec

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,278
    Vintage Goose
    Jun 13, 2016
  10. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    1,162
    Ronen E
    Apr 29, 2016
  11. VinayN

    Regulatory Affairs Certification (RAC) from RAPS - is it really worth it?

    VinayN, Jan 3, 2016
    Replies:
    1
    Views:
    7,266
    Jim Hagenbaugh
    Jan 5, 2016
  12. VladimirDenmark

    GDPR

    VladimirDenmark, Feb 1, 2024
    Replies:
    0
    Views:
    474
    VladimirDenmark
    Feb 1, 2024
  13. bozidar

    EU MDR transitional period extension

    bozidar, Mar 6, 2023
    Replies:
    0
    Views:
    1,516
    bozidar
    Mar 6, 2023
  14. Heather Hargreaves

    Veterinary Medical Devices

    Heather Hargreaves, Mar 2, 2022
    Replies:
    0
    Views:
    1,916
    Heather Hargreaves
    Mar 2, 2022
  15. mtn_sa

    RED, LVD, MDR

    mtn_sa, May 19, 2020
    Replies:
    0
    Views:
    1,084
    mtn_sa
    May 19, 2020
  16. ThomasPonçot

    Marketing sticker on Medical Device outer box?

    ThomasPonçot, Nov 22, 2019
    Replies:
    0
    Views:
    1,389
    ThomasPonçot
    Nov 22, 2019
  17. alexamine90

    OEM/PLM collaboration under the new MDR

    alexamine90, Apr 17, 2019
    Replies:
    0
    Views:
    1,972
    alexamine90
    Apr 17, 2019
  18. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    1,558
    riri1912
    Feb 6, 2018
  19. Irene

    INFO for notification/registration of medical device in UK

    Irene, Jun 30, 2017
    Replies:
    0
    Views:
    826
    Irene
    Jun 30, 2017
  20. Ronen E

    Cost indication for EC IVD design examination

    Ronen E, Nov 12, 2015
    Replies:
    0
    Views:
    722
    Ronen E
    Nov 12, 2015
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