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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:
    0
    Views:
    114
    khamec
    Feb 22, 2017
  2. HS330

    Research use only

    HS330, Dec 16, 2016
    Replies:
    1
    Views:
    147
    Vintage Goose
    Dec 16, 2016
  3. fialor

    Registration with MHRA

    fialor, Sep 6, 2016
    Replies:
    2
    Views:
    157
    fialor
    Sep 6, 2016
  4. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    1,513
    Xavier Canals-Riera
    Jun 22, 2016
  5. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    0
    Views:
    147
    Anna Lee
    Jun 21, 2016
  6. khamec

    annex Za (Risk assessment)

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    180
    yodon
    Jun 13, 2016
  7. khamec

    Class III OBL STED format

    khamec, Jun 13, 2016
    Replies:
    1
    Views:
    324
    Vintage Goose
    Jun 13, 2016
  8. Walker

    Signing an Article 12 document

    Walker, May 9, 2016
    Replies:
    2
    Views:
    210
    Walker
    May 16, 2016
  9. QAengineer13

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

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    227
    Monica
    May 5, 2016
  10. Jo Campbell

    EtO Sterilisation of Syringes

    Jo Campbell, Apr 29, 2016
    Replies:
    1
    Views:
    206
    Ronen E
    Apr 29, 2016
  11. Vintage Goose

    Registration of IVDs in Poland

    Vintage Goose, Apr 19, 2016
    Replies:
    2
    Views:
    152
    Vintage Goose
    Apr 20, 2016
  12. QAengineer13

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

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    230
    Ronen E
    Apr 15, 2016
  13. Michelle Dempsey

    Declaration of Conformity 93/42/EEC

    Michelle Dempsey, Apr 13, 2016
    Replies:
    3
    Views:
    199
    Pads38
    Apr 13, 2016
  14. lola parra asensio

    Class Im auto-certificate or not

    lola parra asensio, Jan 29, 2016
    Replies:
    9
    Views:
    450
    Ronen E
    Feb 2, 2016
  15. Nicky

    Authorised rep question

    Nicky, Jan 29, 2016
    Replies:
    2
    Views:
    232
    Nicky
    Jan 29, 2016
  16. MarkMeer

    Notified Body Debacle

    MarkMeer, Jan 25, 2016
    Replies:
    14
    Views:
    828
    Ronen E
    Jan 27, 2016
  17. Jo Campbell

    Additional Notified Body

    Jo Campbell, Oct 15, 2015
    Replies:
    6
    Views:
    505
    pdzip
    Jan 22, 2016
  18. Sing Wee

    CE mark submission

    Sing Wee, Jan 8, 2016
    Replies:
    3
    Views:
    374
    pdzip
    Jan 22, 2016
  19. Jo Campbell

    Extension to Scope

    Jo Campbell, Jan 14, 2016
    Replies:
    2
    Views:
    208
    Jo Campbell
    Jan 15, 2016
  20. VinayN

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

    VinayN, Jan 3, 2016
    Replies:
    1
    Views:
    1,201
    Jim Hagenbaugh
    Jan 5, 2016
Showing threads 1 to 20 of 26

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