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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. QAengineer13

    2014/35/EU ( LVD Directive) Compliance for IVD ?

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    1,703
    Ronen E
    Apr 15, 2016
  2. Jo Campbell

    Additional Notified Body

    Jo Campbell, Oct 15, 2015
    Replies:
    6
    Views:
    1,782
    pdzip
    Jan 22, 2016
  3. khamec

    annex Za (Risk assessment)

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,070
    yodon
    Jun 13, 2016
  4. Amy G

    Article 12 Procedure Pack Labelling Requirements

    Amy G, Oct 2, 2018
    Replies:
    1
    Views:
    2,156
    Stephen1985
    Jul 26, 2021
  5. Nicky

    Authorised rep question

    Nicky, Jan 29, 2016
    Replies:
    2
    Views:
    1,106
    Nicky
    Jan 29, 2016
  6. Achaos

    Biological Evaluation acc. to ISO 10993-1

    Achaos, Aug 29, 2015
    Replies:
    11
    Views:
    2,470
    jojo63
    Oct 16, 2015
  7. Sing Wee

    CE mark submission

    Sing Wee, Jan 8, 2016
    Replies:
    3
    Views:
    1,252
    pdzip
    Jan 22, 2016
  8. Jo Campbell

    Changing the classification of a medical device

    Jo Campbell, Oct 5, 2015
    Replies:
    8
    Views:
    1,429
    Jo Campbell
    Oct 6, 2015
  9. khamec

    Circumcision Device: Is it a Medical Device?

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

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    1,278
    Vintage Goose
    Jun 13, 2016
  11. lola parra asensio

    Class Im auto-certificate or not

    lola parra asensio, Jan 29, 2016
    Replies:
    9
    Views:
    2,517
    Ronen E
    Feb 2, 2016
  12. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    1,557
    riri1912
    Feb 6, 2018
  13. Jo Campbell

    Company name change and product labelling

    Jo Campbell, Oct 9, 2015
    Replies:
    2
    Views:
    1,021
    Jo Campbell
    Oct 13, 2015
  14. Ronen E

    Cost indication for EC IVD design examination

    Ronen E, Nov 12, 2015
    Replies:
    0
    Views:
    721
    Ronen E
    Nov 12, 2015
  15. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    1,092
    Pads38
    Apr 13, 2016
  16. Amy G

    Electronic Signatures

    Amy G, Oct 19, 2018
    Replies:
    1
    Views:
    802
    yodon
    Oct 19, 2018
  17. Jo Campbell

    ETO Sterilisation

    Jo Campbell, Nov 13, 2015
    Replies:
    2
    Views:
    819
    Jo Campbell
    Nov 23, 2015
  18. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    1,161
    Ronen E
    Apr 29, 2016
  19. bozidar

    EU MDR transitional period extension

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

    EU REACH compliance

    emmamartsolf, Jun 27, 2017
    Replies:
    1
    Views:
    938
    johnnymo77
    Jun 27, 2017
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