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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. VladimirDenmark

    GDPR

    VladimirDenmark, Feb 1, 2024
    Replies:
    0
    Views:
    483
    VladimirDenmark
    Feb 1, 2024
  2. Ronen E

    Cost indication for EC IVD design examination

    Ronen E, Nov 12, 2015
    Replies:
    0
    Views:
    722
    Ronen E
    Nov 12, 2015
  3. Amy G

    Electronic Signatures

    Amy G, Oct 19, 2018
    Replies:
    1
    Views:
    807
    yodon
    Oct 19, 2018
  4. Jo Campbell

    ETO Sterilisation

    Jo Campbell, Nov 13, 2015
    Replies:
    2
    Views:
    823
    Jo Campbell
    Nov 23, 2015
  5. Irene

    INFO for notification/registration of medical device in UK

    Irene, Jun 30, 2017
    Replies:
    0
    Views:
    826
    Irene
    Jun 30, 2017
  6. emmamartsolf

    EU REACH compliance

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

    Extension to Scope

    Jo Campbell, Jan 14, 2016
    Replies:
    2
    Views:
    970
    Jo Campbell
    Jan 15, 2016
  8. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    1,018
    Walker
    May 16, 2016
  9. Jo Campbell

    Company name change and product labelling

    Jo Campbell, Oct 9, 2015
    Replies:
    2
    Views:
    1,025
    Jo Campbell
    Oct 13, 2015
  10. khamec

    annex Za (Risk assessment)

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

    RED, LVD, MDR

    mtn_sa, May 19, 2020
    Replies:
    0
    Views:
    1,084
    mtn_sa
    May 19, 2020
  12. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    1,095
    Pads38
    Apr 13, 2016
  13. Nicky

    Authorised rep question

    Nicky, Jan 29, 2016
    Replies:
    2
    Views:
    1,109
    Nicky
    Jan 29, 2016
  14. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    1,162
    Ronen E
    Apr 29, 2016
  15. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    1,183
    Vintage Goose
    Apr 20, 2016
  16. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    1,206
    Vintage Goose
    Dec 16, 2016
  17. Chr1sG

    IVDR or MDR

    Chr1sG, Apr 23, 2020
    Replies:
    2
    Views:
    1,215
    Chr1sG
    Apr 29, 2020
  18. Sing Wee

    CE mark submission

    Sing Wee, Jan 8, 2016
    Replies:
    3
    Views:
    1,257
    pdzip
    Jan 22, 2016
  19. khamec

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,278
    Vintage Goose
    Jun 13, 2016
  20. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    1,309
    fialor
    Sep 6, 2016
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