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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. Heather Hargreaves

    Veterinary Medical Devices

    Heather Hargreaves, Mar 2, 2022
    Replies:
    0
    Views:
    1,919
    Heather Hargreaves
    Mar 2, 2022
  2. Jon Cook

    Technical File - machinery directive/PPE directive

    Jon Cook, Nov 24, 2015
    Replies:
    5
    Views:
    1,605
    Steve Kent
    Nov 26, 2015
  3. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    1,024
    Walker
    May 16, 2016
  4. QAengineer13

    RoHS 2( 2011/65/EU) Lab instrument compliance date?

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    1,346
    Monica
    May 5, 2016
  5. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    5,402
    Xavier Canals-Riera
    Jun 22, 2016
  6. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    1,214
    Vintage Goose
    Dec 16, 2016
  7. VinayN

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

    VinayN, Jan 3, 2016
    Replies:
    1
    Views:
    7,310
    Jim Hagenbaugh
    Jan 5, 2016
  8. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    1,316
    fialor
    Sep 6, 2016
  9. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    1,188
    Vintage Goose
    Apr 20, 2016
  10. mtn_sa

    RED, LVD, MDR

    mtn_sa, May 19, 2020
    Replies:
    0
    Views:
    1,089
    mtn_sa
    May 19, 2020
  11. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    1
    Views:
    1,827
    Marcus Emne
    Apr 8, 2021
  12. Kolleen Marie Tener

    Procedure for EU MDR Clinical Investigation

    Kolleen Marie Tener, Aug 26, 2020
    Replies:
    1
    Views:
    1,542
    yodon
    Aug 27, 2020
  13. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    1,437
    indicator
    Sep 7, 2017
  14. alexamine90

    OEM/PLM collaboration under the new MDR

    alexamine90, Apr 17, 2019
    Replies:
    0
    Views:
    1,983
    alexamine90
    Apr 17, 2019
  15. MarkMeer

    Notified Body Debacle

    MarkMeer, Jan 25, 2016
    Replies:
    14
    Views:
    3,611
    Ronen E
    Jan 27, 2016
  16. ThomasPonçot

    Marketing sticker on Medical Device outer box?

    ThomasPonçot, Nov 22, 2019
    Replies:
    0
    Views:
    1,395
    ThomasPonçot
    Nov 22, 2019
  17. Chr1sG

    IVDR or MDR

    Chr1sG, Apr 23, 2020
    Replies:
    2
    Views:
    1,226
    Chr1sG
    Apr 29, 2020
  18. Irene

    INFO for notification/registration of medical device in UK

    Irene, Jun 30, 2017
    Replies:
    0
    Views:
    832
    Irene
    Jun 30, 2017
  19. VladimirDenmark

    GDPR

    VladimirDenmark, Feb 1, 2024
    Replies:
    0
    Views:
    546
    VladimirDenmark
    Feb 1, 2024
  20. Jo Campbell

    Extension to Scope

    Jo Campbell, Jan 14, 2016
    Replies:
    2
    Views:
    972
    Jo Campbell
    Jan 15, 2016
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