UK Regulations

UK Regulatory Update

Brexit was the withdrawal of the United Kingdom (UK) from the European Union (EU) at 23:00 GMT on
31 January 2020 (00:00 1 February 2020 CET). The UK is the only sovereign country to have left the EU.
The UK had been a member state of the EU or its predecessor the European Communities, sometimes
of both at the same time since 1 January 1973.


The UK (England, Scotland, and Wales) has now become a “third country” post Brexit. As a result, the
UK has introduced new regulations on all imported medical devices. Reference the following
regulations: 2021 No. 873, 2020 No. 1478, 2019 No. 791, 2002 No. 618, and (EU) 2023/607.


UK’s regulations require manufacturers based outside the UK to appointment a local UK Responsible
Person (UKRP) for all medical devices imported and sold on the UK market. Medical devices to be
imported into the UK must be registered by the manufacturer with the MHRA prior to import. Medical
devices eligible for import will be listed in the MHRA database.


Merit Medical’s UKRP Business Information:

Merit Medical UK Limited

Unit 27 Suttons Business Park

Earley, Reading

RG6 1 AZ

United Kingdom

UKRP@Merit.com


On March 30, 2023 the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced
that medical device certificates that have been extended in the European Union by Regulation (EU)
2023/607 (amendment to EU MDR) will also be recognized as valid for placing CE marked devices on
the UK market.


Merit suggests customers consult the latest published regulations and guidance for current labeling,

importer, and distributor obligation informa
tion for the United Kingdom and Northern Ireland at
Regulating Medical devices in the UK
.

Importing Merit’s Products Into the UK

Merit is asking all OEM customers who import sterile medical devices, legally manufactured by Merit,
into the UK to take immediate action towards compliance with these new regulations. The following
information is provided by Merit to assist our OEM customers in their actions towards reaching
compliance.

UK Importer Information

Importers shall indicate on the device or on its packaging or in a document accompanying the device
the importers name, registered trade name or registered trademark (if applicable), its registered place
of business (if applicable), or the address at which it can be contacted.


Customers purchasing sterile finished products, legally manufactured by Merit, will be responsible for
supplying proper identification of their UK Importer before the customer imports the product into the
UK.

Northern Ireland Regulatory Update

Northern Ireland under the ‘Northern Ireland Protocol’, will continue to follow many of the EU’s rules
(MDR (EU) 2017/745 and/or EU 2017/746) and have introduced additional requirements for all imported
medical devices. This means that Northern Ireland will continue to enforce EU Customs Code for goods
entering Northern Ireland from the rest of the UK.


Merit suggests customers consult the latest published regulations and guidance for current importer

and distributor obligation information for the United Kingdom and Northern Ireland at
Regulating
Medical devices in the UK
.

Importing Merit’s Products Into Northern Ireland

Merit is asking all OEM customers who import sterile medical devices, legally manufactured by Merit, into Northern Ireland to take immediate action towards compliance with these new regulations. The following information is provided by Merit to assist our OEM customers in their actions towards reaching compliance.

Distribution Agreements

New distribution agreements may be required for all Merit OEM customers purchasing sterile CE-
marked products legally manufactured by Merit that have distribution in the UK and/or Northern
Ireland. OEM customers with already established distribution agreements may need to have them
amended to include compliance requirements to these new regulations.


If your organization has purchased Merit product intending to import and distribute into the UK and/or Northern Ireland, Merit is asking these customers to please submit their contact information using the form below. Once your contact information has been submitted, your Merit OEM representative will schedule a meeting to discuss your specific requirements and begin the process of establishing or amending a distribution agreement.

Merit is looking forward to working with our OEM customers that might need assistance with these recent changes in the UK and Northern Ireland regulatory requirements.

 

Customers importing sterile finished devices, legally manufactured by Merit into the UK and/or Northern Ireland, please submit your contact information here.

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