Medical Device and IVDs UK Market Access

UKCA - Brexit Implications

UKCA 

Brexit implications

The MHRA presented guidance on the situation of medical devices and IVD’s after  January 1st, 2021. What are the implications of Brexit:

  • The UK will introduce a new route to market – UKCA – available from January 1st, 2021.

Guidance for the MHRA Brexit by Sue Spencer

From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:

  • 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices + Annex II List A IVDs
  • 8 months for other Class IIb and all Class IIa devices + IVD List B, Self-test IVDs
  • 12 months for Class I devices + General IVDs.

The registration with the MHRA can only be submitted by UK manufacturers or UK Responsible Person.

    • UK responsible person needs to have a place of business in the UK
    • a product list including the products that should be registered as well as the referring GMDN code is required
    • If applicable, a copy of the CE certificate should be provided
    • documentary evidence supporting the position of the UK Responsible Person is required (letter of designation, signed contract) including company name and address of the manufacturer not located in the UK before June 2023
    • One application consists of products having the same GMDN code
    • Manufacturers not established in the UK who need to designate a UK Responsible Person do not need to change the labelling of their products placed on the UK market

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News and Updates

Conformity Assessment Body

  • From 1 January 2021, the MHRA will be able to designate UK Conformity Assessment Bodies (CABs) to conduct assessments against UK requirements for the purpose of the UKCA mark.
  • These Bodies will be known as ‘Approved Bodies’ as of 1 January 2021.
  • Existing UK Notified Bodies with designations under the MDD, IVDD or AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
  • UK Approved Bodies will only be able to conduct conformity assessments for medical devices, active implantable medical devices and in vitro diagnostic medical devices under UK MDR 2002 in the form in which they exist on 1 January 2021

The role of the UKRP includes

  • Ensure that the Declaration of Conformity (DOC) and technical documentation exist;
  • "Keep available a copy" of these documents and relevant certificates; 
  • Ensure application of appropriate conformity assessment procedures; and
  • Cooperate with the MHRA's request for documents, et al.

        UK Responsible Person 

 

 

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