Everything You Need To Know About The UKNI Mark

by | Nov 6, 2020 | Brexit, EU, FDA, Medical Devices, Quality, Regulatory, UKNI

The Brexit has not only impacted Britain and the EU, it has made changes to the Northern Ireland region as well. As the UK will start implementing the UKCA mark, the Northern Ireland region will start using the UKNI mark for certain products.

Let’s look at some of the key requirements to place a medical device on the Northern Ireland market:

EU MDR and EU IVDR:

While Britain will not be implementing the EU MDR and IVDR, since the implementation date is after the Brexit transition period, Northern Ireland on the other hand will start implementing the EU MDR and IVDR from 26 May 2021 and 26 May 2022 respectively.1

CE Marking:

CE marking will continue to be required in Northern Ireland in addition to the UKNI mark, which is required if the UK notified body undertakes the mandatory third party conformity assessment of the product.1

Product Registrations:

Post the transition period, certain medical devices and IVDRs in the Northern Ireland market will need to be registered with the UK MHRA. The registration timelines are as follows:1

  • Class I devices and IVDs placed on the market by Northern Ireland Manufacturers and authorized representatives must be registered from January 1st, 2021
  • Class III and Class IIb implantables, all active implantable medical devices, and IVD products must be registered from 1st May 2021
  • Other Class IIb, all Class IIa devices, and Self-Test IVDs must be registered from 1st September 2021

Authorized Representative:

Great Britain manufacturers will have to appoint an EU or Northern Ireland based authorized representative when placing the product on the Northern Ireland Market.1

A UK Responsible Person will also have to be appointed for all manufacturers outside of the UK that are placing their products in the Northern Ireland market to comply with the registration requirements.1 

The regulations are ever-evolving with the Brexit transition period coming to an end soon. EMMA International is here to help with all your regulatory needs. Give us a call today at +1 248-987-4497 or email us at info@emmainternational.com to know more.


1GOV.UK (Nov 2021) Regulating medical devices from 1 January 2021 retrieved on 11/04/2020 from https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021?utm_source=f6d51702-ec92-40f2-87b0-487aebb0bf8a&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate#NI

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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