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Donawa Lifescience opens GB company to provide UKRP services

  • Posted by: Roger Gray

Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a company in Great Britain (GB), Donawa Lifescience Ltd., to provide non-UK companies with ‘United Kingdom Responsible Person’ (UKRP) services as an easy initial pathway to the post-Brexit medical device market in Great Britain.

Following the publication of the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guidance on access to the UK market after a ‘no-deal’ Brexit on 1 September, updated on 21 October, and the UK government’s publication of the draft amendments to the existing UK device law on the same day, it has now been clarified that the UKRP can be a separate entity from the Importer, whereas the previous draft from late 2019 mandated that the importer would become the UKRP.

With this clarification, Donawa is pleased to announce that a sister company has been set up in England in order to provide UKRP services, not only to its existing European Authorised Representative (AR) clients, but also to new clients, especially European device manufacturers who will eventually have to designate a UKRP once the CE mark is no longer recognised in GB, which is from 30 June 2023. While the UKRP details will not need to be included on labelling for CE marked devices until 30 June 2023, non-UK manufacturers must still appoint a UKRP from 1 January 2021, and the UKRP must register the manufacturer’s devices with the MHRA from dates that are related to device classification, these being:

From 1 May 2021:

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

From 1 September 2021:

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

From 1 January 2022:

  • Class I medical devices
  • General IVDs

It will be possible to register devices ahead of the above dates, but there will be no legal obligation to do so.

Where a medical device is already registered with the MHRA, it will not need to be re-registered after 1 January 2021. However, manufacturers (or the UKRP) will be required to review the information held by MHRA to ensure it remains correct in line with the above grace periods.

It should be noted that the arrangements for economic operators based in Northern Ireland are different, as explained on the MHRA webpage.

The Donawa Lifescience Office office is located at Aviation Business Park, Christchurch BH23 6NX, UK.

All enquiries regarding UKRP services should be addressed in the first instance to:
Roger Gray, VP Quality and Regulatory, Donawa Lifescience
Email: rgray@donawa.com
Tel: +39 06 578 2665