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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. khamec

    Circumcision Device: Is it a Medical Device?

    khamec, Feb 22, 2017
    Replies:
    2
    Views:
    1,742
    Engr. Rashid Ali
    Mar 11, 2019
  2. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    1,316
    fialor
    Sep 6, 2016
  3. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    1,023
    Walker
    May 16, 2016
  4. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    1,188
    Vintage Goose
    Apr 20, 2016
  5. Nicky

    Authorised rep question

    Nicky, Jan 29, 2016
    Replies:
    2
    Views:
    1,111
    Nicky
    Jan 29, 2016
  6. Jo Campbell

    Extension to Scope

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

    ETO Sterilisation

    Jo Campbell, Nov 13, 2015
    Replies:
    2
    Views:
    826
    Jo Campbell
    Nov 23, 2015
  8. Jo Campbell

    Company name change and product labelling

    Jo Campbell, Oct 9, 2015
    Replies:
    2
    Views:
    1,028
    Jo Campbell
    Oct 13, 2015
  9. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    1,437
    indicator
    Sep 7, 2017
  10. QAengineer13

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

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    1,343
    Monica
    May 5, 2016
  11. QAengineer13

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

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    1,713
    Ronen E
    Apr 15, 2016
  12. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    1,099
    Pads38
    Apr 13, 2016
  13. Sing Wee

    CE mark submission

    Sing Wee, Jan 8, 2016
    Replies:
    3
    Views:
    1,267
    pdzip
    Jan 22, 2016
  14. Jon Cook

    Technical File - machinery directive/PPE directive

    Jon Cook, Nov 24, 2015
    Replies:
    5
    Views:
    1,603
    Steve Kent
    Nov 26, 2015
  15. Jo Campbell

    Additional Notified Body

    Jo Campbell, Oct 15, 2015
    Replies:
    6
    Views:
    1,797
    pdzip
    Jan 22, 2016
  16. Jo Campbell

    Changing the classification of a medical device

    Jo Campbell, Oct 5, 2015
    Replies:
    8
    Views:
    1,445
    Jo Campbell
    Oct 6, 2015
  17. lola parra asensio

    Class Im auto-certificate or not

    lola parra asensio, Jan 29, 2016
    Replies:
    9
    Views:
    2,539
    Ronen E
    Feb 2, 2016
  18. Achaos

    Biological Evaluation acc. to ISO 10993-1

    Achaos, Aug 29, 2015
    Replies:
    11
    Views:
    2,519
    jojo63
    Oct 16, 2015
  19. MarkMeer

    Notified Body Debacle

    MarkMeer, Jan 25, 2016
    Replies:
    14
    Views:
    3,610
    Ronen E
    Jan 27, 2016
  20. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    5,401
    Xavier Canals-Riera
    Jun 22, 2016
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