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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    457
    riri1912
    Feb 6, 2018
  2. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    327
    indicator
    Sep 7, 2017
  3. Irene

    INFO for notification/registration of medical device in UK

    Irene, Jun 30, 2017
    Replies:
    0
    Views:
    135
    Irene
    Jun 30, 2017
  4. emmamartsolf

    EU REACH compliance

    emmamartsolf, Jun 27, 2017
    Replies:
    1
    Views:
    166
    johnnymo77
    Jun 27, 2017
  5. khamec

    Circumcision Device: Is it a Medical Device?

    khamec, Feb 22, 2017
    Replies:
    0
    Views:
    295
    khamec
    Feb 22, 2017
  6. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    327
    Vintage Goose
    Dec 16, 2016
  7. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    343
    fialor
    Sep 6, 2016
  8. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    2,319
    Xavier Canals-Riera
    Jun 22, 2016
  9. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    0
    Views:
    289
    Anna Lee
    Jun 21, 2016
  10. khamec

    annex Za (Risk assessment)

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    350
    yodon
    Jun 13, 2016
  11. khamec

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    561
    Vintage Goose
    Jun 13, 2016
  12. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    370
    Walker
    May 16, 2016
  13. QAengineer13

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

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    430
    Monica
    May 5, 2016
  14. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    380
    Ronen E
    Apr 29, 2016
  15. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    352
    Vintage Goose
    Apr 20, 2016
  16. QAengineer13

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

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    488
    Ronen E
    Apr 15, 2016
  17. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    376
    Pads38
    Apr 13, 2016
  18. lola parra asensio

    Class Im auto-certificate or not

    lola parra asensio, Jan 29, 2016
    Replies:
    9
    Views:
    926
    Ronen E
    Feb 2, 2016
  19. Nicky

    Authorised rep question

    Nicky, Jan 29, 2016
    Replies:
    2
    Views:
    427
    Nicky
    Jan 29, 2016
  20. MarkMeer

    Notified Body Debacle

    MarkMeer, Jan 25, 2016
    Replies:
    14
    Views:
    1,443
    Ronen E
    Jan 27, 2016
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