Lorenzo Tempesti -

No deal-Brexit grace period end is now upon us and starting from 1st January 2021 all the manufacturers wishing to place medical devices in the UK market shall comply with the UK MDR 2002.

From 1st January 2021 the medical devices shall be registered in the MHRA database according to the deadline reported in the registration guideline issued by the MHRA (Guidance to register medical devices to place on the market from 1 January 2021).

A grace period is foreseen for the registration with the MHRA according to the medical device risk classification. The registration will become mandatory from 1st May 2021 for:

  • Active implantable medical devices
  • Class III medical devices
  • Class IIb implantable medical devices
  • IVD List A products

From 1st September 2021 for:

  • Class IIb non-implantable medical devices
  • Class IIa medical devices
  • IVD List B products
  • Self-test IVDs

From 1st January 2022 where they have not previously been required to be registered with the MHRA (manufacturer or Authorised Representative is not based in the UK):

  • Class I medical devices
  • General IVDs

An important issue to be considered is that MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business in the UK therefore if the manufacturer is based outside of the UK, they will need to appoint a UK Responsible Person as soon as possible starting from 1st January 2021.

Regulatory Pharma Net offers full regulatory support and is available for any clarification and assistance, please do not hesitate to contact us!

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