The UK government has published a further set of draft amendments to the Medical Devices Regulations 2002 (as previously amended), for which a draft amendment was published in late 2019 (the ‘Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019’), but which has now been further amended in ‘The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020’, available from the legislation.gov.uk website. It is important to note that the website states: “This is a draft item of legislation and has not yet been made as a UK Statutory Instrument” (SI).
The draft is made up of a set of individual amendments to the clauses of the 2002 regulations (as previously amended), as per the 2019 draft, but now also including the 2020 revisions to the previous versions, including amendments to the 2019 draft. There is no official consolidated version of the 2020 draft available from the government, but presumably someone will produce an unofficial version soon, so we can all understand what the SI will actually say and what all economic operators will need to do to conform.
One of the changes from the 2019 draft noticed immediately is the separation of the responsibilities of the Importer and the UK Responsible Person (UKRP), which were previously intertwined.
The 2020 draft appears to mirror what the MHRA published on its website on 1 September 2020, but there may still need to be changes associated with how the new SI will affect economic operators based in Northern Ireland, depending on whether the country will remain part of the European Customs Union after the Brexit transition period on 31 December 2020.