Why You Now Need a UK-Based Importer
When the United Kingdom split from the EU, they were no longer required to adopt European medical device regulations as national law. Manufacturers now must register with the MHRA and follow newly updated UK MHRA regulations, which closely follow the MDR and IVDR. This also means that manufacturers with no legal entity in the UK must appoint of a Great Britain Importer for goods sold in England, Scotland and Wales. With an office in the UK, MedEnvoy offers an independent importer service designed to meet your MHRA obligations while minimizing disruption of your product release and shipping processes.
MedEnvoy can act as your importer in the EU, UK and Switzerland!
Great Britain Importer Responsibilities
Now that the MHRA solely controls device regulation, they now require you to have an importer. We can assist with this and perform the following mandated tasks:
- Verify that devices sold in Great Britain carry the CE Mark or new UKCA Mark (if applicable)
- Verify declaration of conformity and technical documentation
- Check the conformity assessment procedure
- Verify labelling and IFU are compliant
- Ensure UDI has been assigned
- Verify that MMDA storage and transportation requirements are fulfilled
- Maintain a register of complaints as required by UK law
- Inform the manufacturer and MHRA if the device provides serious risk/is not in conformity
- Check to ensure that devices have been registered with MHRA
- Check device ID within supply chain
How the UK Importer Process Works
MedEnvoy has developed a process that prevents duplication of efforts among your UK distributor(s) and UK Responsible Person. We utilize technology to streamline the review and approval of your documentation and other UK MHRA obligations.
For maximum efficiency, we will work with you to develop contractual arrangements and QMS procedures which will prevent redundant activities from being performed while ensuring your compliance with MHRA regulations.
Responsibilities that are specific to the UK importer will be put in place and supported by procedures and work instructions that MedEnvoy will co-develop with you during our onboarding process. This will ensure speedy compliance checks and an uninterrupted flow of product shipments into Great Britain.
Have a subsidiary in the UK?
Manufacturers with an established legal entity in the UK can designate that entity as their Importer. MedEnvoy can provide “white label” back office services to your UK subsidiary to ensure all UK MHRA importer obligations are being met. Your subsidiary name goes on your labeling as importer!
Benefits of Selecting an Independent UK Importer
- Your Importer must be identified on your product labeling. You maintain the flexibility to change distributors without reprinting all labeling.
- The importer must have permanent access to confidential technical documentation. We have no commercial interest in your devices but distributors certainly do.
- Having one company act as your single Swiss, EU and UK importer will streamline the management of contracts, labeling, shipping and overall compliance for all devices sold throughout Europe.
Great Britain Importer Fee Structure
We charge the following fees for companies importing devices into the United Kingdom.
- Onboarding fee (one time)
- Annual importer service fee (based on expected number of annual shipments)
NOTE: If you also work with MedEnvoy as your Swiss and/or EU importer, we can offer a multi-service discount.