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  • 1.  Confused about the UK MDR 2002

    This message was posted by a user wishing to remain anonymous
    Posted 08-Mar-2022 07:09
    This message was posted by a user wishing to remain anonymous

    Can someone please help me clarify this matter:
    So the medical device regulations in the UK is the UK MDR 2002 

    Then we have the Medical devices (amendment) (EU Exit) Regulations 2019
    1. PART 1 is clear, it amends the MDR to break the links to the MDD 
    2. PART 2 and 3 - Are these prospective regulations?  (introducing new parts VIII and IX corresponding to the EU MDR and EU IVDR, replacing the original parts II, III and IV corresponding to the MDD and IVDD) 
    3. PART 4 - this is the amendment to the Annexes but there are also new schedules. I don't understand why are there both Annexes the  Schedules? 
    For example:
    Schedule 9 Classification rules 
    And Annex IX is the classification Criteria 

  • 2.  RE: Confused about the UK MDR 2002

    Posted 09-Mar-2022 06:06
    Hello Anon,

    I would not get too deep or hung up on the UK Medical Device Regulations currently, because these are most likely going to change.  Last year (you probably are aware) there was a consultation/proposal sent out for changing the regulations.  MHRA has indicated they are going to update the 2002/2019 regulations.  And yes it is confusing as there is not necessarily a "consolidated version" which can be reviewed.  There were some other posts on this where you can get to the actual regulation and find the changes/amendments which have been made over the years.  But essentially it is quite the same as the EU MDD and again would not get to harried about what there is currently.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs