Great Britain (UK) Importer
For Medical Device & IVD Manufacturers
Independent UK MHRA Importer Representation from Europe's #1 Regulatory Importer!
Trusted by 550+ Medical Device & IVD Manufacturers Worldwide
Responsive. Knowledgeable. Affordable.
After Brexit, the UK was no longer required to adopt European medical device regulations. That means the EU MDR & IVDR do not apply and you must follow the UK Medicines and Medical Devices Act (MMDA). This UK regulation requires you to appoint a regulatory compliance importer for shipments to England, Scotland, or Wales - collectively called Great Britain.
By working with MedEnvoy as your single designated Great Britain importer, you avoid asking your distributor or distributors to take on this responsibility and therefore maintain more independence at a minimal cost. MedEnvoy already fulfills the role of EU importer and Swiss importer for 250+ medical device companies so we have processes established to verify your compliance quickly and seamlessly with the UK requirements.
Tasks We Perform as Your Designated UK Medical Device Importer
Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD, or devices with CE under the MDR/IVDR, you’ll still require a Great Britain importer based in the UK. We don’t handle your products or slow down shipments but we do...
✓ Verify that devices sold in Great Britain carry the UKCA Mark
✓ Verify UK declaration of conformity and technical documentation
✓ Verify labelling, UDI and accompanying information (IFU)
✓ Manufacturer is identified and UK Responsible Person has been assigned
✓ Verify that MMDA storage and transportation requirements are fulfilled
✓ Maintain a register of complaints as required by UK law
✓ Inform manufacturer if device provides serious risk/is not in conformity
✓ Check to ensure that devices have been registered with MHRA
✓ Report serious incidents or risks to MHRA; cooperate on CAPA issues
MedEnvoy is ISO 13485:2016 certified.
Maintain Flexibility by Keeping Your UK Importer Separate from Your Distributor
Could you appoint your distributor as your importer in Great Britain? Technically, yes. But there are many reasons to avoid doing so. Your distributor is focused on marketing and selling your products, not checking to make sure your labeling, IFU or Unique Device Identification (UDI) are compliant with the UK MDR. Plus, keep in mind that the name and contact information of your chosen UK Importer will be on your labeling – a problem if multiple distributors are used.
If you later switch to a new distributor, all of those products will continue to carry the old distributor’s contact information. Managing your labeling will be logistically challenging and could lead to non-compliance. What’s more, if you also sell in Europe or Northern Ireland, it makes sense to have one independent importer who can represent you in all markets. Learn more about how the process works.
... that your devices have been correctly
registered with UK MHRA
... that your UDI, product labeling and Instructions for Use are present
... you immediately if any product complaints are reported to us
... with the MHRA, your UKRP and distributors if there is a problem