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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. QAengineer13

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

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

    Marketing sticker on Medical Device outer box?

    ThomasPonçot, Nov 22, 2019
    Replies:
    0
    Views:
    1,392
    ThomasPonçot
    Nov 22, 2019
  3. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    1,437
    indicator
    Sep 7, 2017
  4. Jo Campbell

    Changing the classification of a medical device

    Jo Campbell, Oct 5, 2015
    Replies:
    8
    Views:
    1,445
    Jo Campbell
    Oct 6, 2015
  5. bozidar

    EU MDR transitional period extension

    bozidar, Mar 6, 2023
    Replies:
    0
    Views:
    1,521
    bozidar
    Mar 6, 2023
  6. Kolleen Marie Tener

    Procedure for EU MDR Clinical Investigation

    Kolleen Marie Tener, Aug 26, 2020
    Replies:
    1
    Views:
    1,542
    yodon
    Aug 27, 2020
  7. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    1,561
    riri1912
    Feb 6, 2018
  8. Jon Cook

    Technical File - machinery directive/PPE directive

    Jon Cook, Nov 24, 2015
    Replies:
    5
    Views:
    1,603
    Steve Kent
    Nov 26, 2015
  9. QAengineer13

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

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    1,713
    Ronen E
    Apr 15, 2016
  10. khamec

    Circumcision Device: Is it a Medical Device?

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

    Additional Notified Body

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

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    1
    Views:
    1,826
    Marcus Emne
    Apr 8, 2021
  13. Heather Hargreaves

    Veterinary Medical Devices

    Heather Hargreaves, Mar 2, 2022
    Replies:
    0
    Views:
    1,918
    Heather Hargreaves
    Mar 2, 2022
  14. alexamine90

    OEM/PLM collaboration under the new MDR

    alexamine90, Apr 17, 2019
    Replies:
    0
    Views:
    1,982
    alexamine90
    Apr 17, 2019
  15. Amy G

    Article 12 Procedure Pack Labelling Requirements

    Amy G, Oct 2, 2018
    Replies:
    1
    Views:
    2,162
    Stephen1985
    Jul 26, 2021
  16. Achaos

    Biological Evaluation acc. to ISO 10993-1

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

    Notified Body Debacle

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

    Revision of the MDD

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

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

    VinayN, Jan 3, 2016
    Replies:
    1
    Views:
    7,308
    Jim Hagenbaugh
    Jan 5, 2016
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