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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. khamec

    annex Za (Risk assessment)

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,070
    yodon
    Jun 13, 2016
  2. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    5,374
    Xavier Canals-Riera
    Jun 22, 2016
  3. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    1,307
    fialor
    Sep 6, 2016
  4. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    1,205
    Vintage Goose
    Dec 16, 2016
  5. emmamartsolf

    EU REACH compliance

    emmamartsolf, Jun 27, 2017
    Replies:
    1
    Views:
    938
    johnnymo77
    Jun 27, 2017
  6. Irene

    INFO for notification/registration of medical device in UK

    Irene, Jun 30, 2017
    Replies:
    0
    Views:
    825
    Irene
    Jun 30, 2017
  7. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    1,426
    indicator
    Sep 7, 2017
  8. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    1,557
    riri1912
    Feb 6, 2018
  9. Amy G

    Electronic Signatures

    Amy G, Oct 19, 2018
    Replies:
    1
    Views:
    802
    yodon
    Oct 19, 2018
  10. khamec

    Circumcision Device: Is it a Medical Device?

    khamec, Feb 22, 2017
    Replies:
    2
    Views:
    1,730
    Engr. Rashid Ali
    Mar 11, 2019
  11. alexamine90

    OEM/PLM collaboration under the new MDR

    alexamine90, Apr 17, 2019
    Replies:
    0
    Views:
    1,970
    alexamine90
    Apr 17, 2019
  12. ThomasPonçot

    Marketing sticker on Medical Device outer box?

    ThomasPonçot, Nov 22, 2019
    Replies:
    0
    Views:
    1,388
    ThomasPonçot
    Nov 22, 2019
  13. Chr1sG

    IVDR or MDR

    Chr1sG, Apr 23, 2020
    Replies:
    2
    Views:
    1,209
    Chr1sG
    Apr 29, 2020
  14. mtn_sa

    RED, LVD, MDR

    mtn_sa, May 19, 2020
    Replies:
    0
    Views:
    1,082
    mtn_sa
    May 19, 2020
  15. Kolleen Marie Tener

    Procedure for EU MDR Clinical Investigation

    Kolleen Marie Tener, Aug 26, 2020
    Replies:
    1
    Views:
    1,538
    yodon
    Aug 27, 2020
  16. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    1
    Views:
    1,821
    Marcus Emne
    Apr 8, 2021
  17. Amy G

    Article 12 Procedure Pack Labelling Requirements

    Amy G, Oct 2, 2018
    Replies:
    1
    Views:
    2,156
    Stephen1985
    Jul 26, 2021
  18. Heather Hargreaves

    Veterinary Medical Devices

    Heather Hargreaves, Mar 2, 2022
    Replies:
    0
    Views:
    1,915
    Heather Hargreaves
    Mar 2, 2022
  19. bozidar

    EU MDR transitional period extension

    bozidar, Mar 6, 2023
    Replies:
    0
    Views:
    1,514
    bozidar
    Mar 6, 2023
  20. VladimirDenmark

    GDPR

    VladimirDenmark, Feb 1, 2024
    Replies:
    0
    Views:
    452
    VladimirDenmark
    Feb 1, 2024
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