Software in Medical Devices, by MD101 Consulting

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Brexit: Regulating medical devices from 1 January 2021 in the UK

While the winds of Covid are blowing a bad air on Europe, the UK MHRA published in September 2020 the guidance on regulatory status of medical devices, IVD and AIMD from 1 January 2021.

No MDR, surviving MDD

Keeping deliberately appart changes on UK responsible person, registration, vigilance, surveillance, labeling, and the role of MHRA, the main information for software MD manufacturers is that:

  • the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain and will not be implemented in Great Britain (quote from the guidance),
  • the transposition of the MDD, IVDD and AIMDD in UK law (UK medical devices regulation 2002) will continue to be applicable from 1 January 2021,
  • Medicines and Medical Devices Bill 2019-21 is being reviewed by the UK Parliament.

As far as I know and read in the Bill 2019-21, there is absolutely NO change about the classification of medical devices in the UK, compared to the existing directives. Same observation with other legislative changes.


The Consequence Is That Most Of Software As a Medical Device (SaMD) Will Continue To Be In Class I (ONE) In The UK from 1 January 2021, unless they change the classification system. I dare imagine that they won't copy and paste the ill-formed Rule 11 of the MDR into the new UK Medical Device Law. And if by chance the UK update their regulation with the IMDRF SaMD classification, lots of SaMD with diagnosis or treatment purposes will still be in class I.

Consequence

If you are a start-up with some fancy but low-risk software, on which market will you go in priority?

  • First, class I in the UK,
  • Second, risk-based approach and predicate in the USA, and also presub meetings to know how to clear your software,
  • Last, class IIa and above in EU, where you will have to bring a clinical data loaf, and wait for a very busy Notified Body to kindly accept your submission.



If you are a bunch of smart people (SW engineers, data scientists, MD's, PharmsD's...), at ease in international and english-speaking environments, if you have top-notch algorithms, if you are creating a start-up and are raising funds, where will you go to finance your project in priority:

  • First, the USA,
  • Second, the UK,
  • Last, the EU.



Yet, this is just speculations! We still don't know what the UK Parliament will vote after January 2021. We don't know either how the MHRA will regulate class I devices and inspect manufacturers in the near future.
Maybe the UK will be the land of milk and honey, maybe not.



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