EU Importer Services
Why Do You Need EU Importer Service To Promote Your Medical Device in UK?
MHRA stands for Medicines and Healthcare Products Regulatory Agency. Being a manufacturer of medical device and with a plan to promote products in UK, are you on the fence whether you should have a UK MHRA importer to advance? Yes, that is, in fact after Brexit was formed in early 2020, the UK no longer have to follow the European medical device rules and regulations.
This means you do not have to adhere to the rules of EU MDR and IDVR. These were a set of directives which govern the manufacture and distribution of medical devices in Europe. Instead of IDVR, EU MDR, you have to comply with the Medical Devices Act (MMDA). This UK law needs you to appoint a governing compliance EU importer for sending consignments to Great Britain, which encompasses England, Wales, and Scotland.
Irrespective of whether you are involved in selling devices holding recent CE certificates under the MDD/IVDD, or devices associated with CE under the MDR/IVDR, or you are having UK Conformity Assessed (UKCA) marking, you still need EU Importer service based in the United Kingdom.
Your Sole UK Importer for Increased Independence and Compliance Verification
Thankfully, we at Cert 3 Global is equipped with EU import licence Great Britain. By working with us, you can avoid the hassle of requesting asking your distributors to tackle with this responsibility. Furthermore, Cert 3 Global is the sole Swiss importer and EU and, so there are established processes to analyse your compliance quickly and flawlessly with the UK guidelines.
With import license EU We, your designated UK Importer will take up the responsibilities as stated below:
- Checking whether the devices sold in Great Britain have the UKCA mark.
- Verifying the accompanying information (IFU), labelling, and UDI.
- Assessing the technical documentation and UK declaration of conformity.
- Ensuring that the manufacturers are properly identified and UK Responsible Person is appointed.
- Informing manufacturer if there is any issue with the medical device.
- Verifying that transportation requirements and MMDA storage are met.
- Keeping a register of complaints as declared by the UK law.
- Making sure that devices are registered under Medicines and Healthcare Products Regulatory Agency (MHRA).
- Cooperating on Corrective and Preventive Actions (CAPA) issues.