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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 20191.
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