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EU Medical Device Regulations

European Union Medical Device Regulations

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  1. VinayN

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

    VinayN, Jan 3, 2016
    Replies:
    1
    Views:
    7,239
    Jim Hagenbaugh
    Jan 5, 2016
  2. JCIC49

    Revision of the MDD

    JCIC49, Aug 17, 2015
    Replies:
    19
    Views:
    5,371
    Xavier Canals-Riera
    Jun 22, 2016
  3. MarkMeer

    Notified Body Debacle

    MarkMeer, Jan 25, 2016
    Replies:
    14
    Views:
    3,575
    Ronen E
    Jan 27, 2016
  4. lola parra asensio

    Class Im auto-certificate or not

    lola parra asensio, Jan 29, 2016
    Replies:
    9
    Views:
    2,506
    Ronen E
    Feb 2, 2016
  5. Achaos

    Biological Evaluation acc. to ISO 10993-1

    Achaos, Aug 29, 2015
    Replies:
    11
    Views:
    2,465
    jojo63
    Oct 16, 2015
  6. Amy G

    Article 12 Procedure Pack Labelling Requirements

    Amy G, Oct 2, 2018
    Replies:
    1
    Views:
    2,155
    Stephen1985
    Jul 26, 2021
  7. alexamine90

    OEM/PLM collaboration under the new MDR

    alexamine90, Apr 17, 2019
    Replies:
    0
    Views:
    1,969
    alexamine90
    Apr 17, 2019
  8. Heather Hargreaves

    Veterinary Medical Devices

    Heather Hargreaves, Mar 2, 2022
    Replies:
    0
    Views:
    1,913
    Heather Hargreaves
    Mar 2, 2022
  9. Anna Lee

    Recommendation for a book about the EU regulations

    Anna Lee, Jun 21, 2016
    Replies:
    1
    Views:
    1,821
    Marcus Emne
    Apr 8, 2021
  10. Jo Campbell

    Additional Notified Body

    Jo Campbell, Oct 15, 2015
    Replies:
    6
    Views:
    1,779
    pdzip
    Jan 22, 2016
  11. khamec

    Circumcision Device: Is it a Medical Device?

    khamec, Feb 22, 2017
    Replies:
    2
    Views:
    1,728
    Engr. Rashid Ali
    Mar 11, 2019
  12. QAengineer13

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

    QAengineer13, Apr 14, 2016
    Replies:
    3
    Views:
    1,699
    Ronen E
    Apr 15, 2016
  13. Jon Cook

    Technical File - machinery directive/PPE directive

    Jon Cook, Nov 24, 2015
    Replies:
    5
    Views:
    1,570
    Steve Kent
    Nov 26, 2015
  14. riri1912

    clinical evaluation

    riri1912, Feb 6, 2018
    Replies:
    0
    Views:
    1,557
    riri1912
    Feb 6, 2018
  15. Kolleen Marie Tener

    Procedure for EU MDR Clinical Investigation

    Kolleen Marie Tener, Aug 26, 2020
    Replies:
    1
    Views:
    1,538
    yodon
    Aug 27, 2020
  16. bozidar

    EU MDR transitional period extension

    bozidar, Mar 6, 2023
    Replies:
    0
    Views:
    1,514
    bozidar
    Mar 6, 2023
  17. Asquared

    Procedure for Clinical study

    Asquared, Jul 24, 2017
    Replies:
    3
    Views:
    1,424
    indicator
    Sep 7, 2017
  18. Jo Campbell

    Changing the classification of a medical device

    Jo Campbell, Oct 5, 2015
    Replies:
    8
    Views:
    1,424
    Jo Campbell
    Oct 6, 2015
  19. ThomasPonçot

    Marketing sticker on Medical Device outer box?

    ThomasPonçot, Nov 22, 2019
    Replies:
    0
    Views:
    1,385
    ThomasPonçot
    Nov 22, 2019
  20. QAengineer13

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

    QAengineer13, Apr 22, 2016
    Replies:
    3
    Views:
    1,332
    Monica
    May 5, 2016
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