Great Britain UK Importer
For Medical Device & IVD Manufacturers
Independent Importer Representation for Meeting UK Medicines and Medical Devices Act (MMDA) Requirements
When the United Kingdom split from the European Union, they were no longer required to adopt European medical device regulations as national law. That being said, the new UK Medicines and Medical Devices Act (MMDA) of 2021 closely follows European regulations, including the need for manufacturers to appoint an importer based in England, Scotland or Wales - collectively called Great Britain.
By working with MedEnvoy as your official Great Britain importer, you avoid asking your distributor to take on this responsibility and therefore maintain more independence at a minimal cost. MedEnvoy already fulfills the role of EU importer for medical device companies so we have processes established to quickly and seamlessly verify your compliance with the UK MMDA requirements.
MedEnvoy is an independent importer with offices in London, UK
Tasks We Perform as Your Official Great Britain UK 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.
✓ Verify that devices sold in Great Britain carry the UKCA Mark
✓ Verify UK declaration of conformity and technical documentation
✓ Verify proper conformity assessment procedure has been performed
✓ Verify Labelling and accompanying information (IFU)
✓ Verify that Manufacturer has assigned UDI
✓ Manufacturer is identified/responsible person has been assigned
✓ Verify that MMDA storage and transportation requirements are fulfilled
✓ Maintain a register of complaints as required by law
✓ Inform manufacturer if device provides serious risk/is not in conformity
✓ Check to ensure that devices have been registered with MHRA
✓ Report to MHRA regarding serious incidents or risks
✓ Cooperate with MHRA regarding preventative /corrective action
✓ Check identification of devices within the supply chain
The importance of keeping your UK importer separate from your UK distributor
Could you appoint your distributor as your importer in Great Britain? Technically, yes. But here's why that may not make sense. 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 MMDA. Plus, if you also sell in Europe or Northern Ireland, it makes sense to have one independent importer who can represent you in all markets.
... 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 Responsible Person, and distributors if there is a problem