UK Importer Service

 
 

Cert 3 Global: Your Most Reliable Self-governing UK MHRA Importer Representative

Are you a medical device manufacturer and like to introduce your product in the UK. But did you know that you need UK importer service to effectively launch your product in UKi? In fact, with the appearance of Brexit, the UK can no longer adopt European medical device rules and regulations. This means that EU MDR as well as IVDR no longer apply, and thereby it is vital for a company like you to follow the prevailing UK Medicines plus Medical Devices law. The UK regulation requires you to deploy an importer well-versed to comply with the compliance for sending shipments to Great Britain which comprises England, Scotland, and Wales.

 

Irrespective of whether you are involved in selling medical or its equivalent product allowed with CE certificates under the rule of MDD/IVDD, under the rule of MDR/IVDR, or holding UKCA marking, you are still in need of Great Britain importer with headquarters in the UK.

 

We, at Cert 3 Global, are known for our expert services as a Great Britain holder of import license UK.

 

More access more dependence and avail the best services of UK Importer service at an affordable price, Get in touch with us right away. We also specialize in the role of EU importer as well as Swiss importer, and therefore we boast of having processes to evaluate your compliance seamlessly and promptly to get started in UK.

 

The Services That You Can Expect from US:

 

  • Assessing that the device to be sold in Great Britain holds the UKCA mark
  • Verifying UK declaration of technical documentation and conformity
  • Checking labeling, additional information related to IFU and UDI
  • Ensuring that the producer is recognized and is assigned with a UK Responsible Person.
  • Help maintain a record of complaints as needed by UK law
  • To confirm that required MMDA storage and transportation necessities are fulfilled
  • Informing the manufacturer if there is any serious risk which is not ideal to stick to the conformity standard.
  • Check to ascertain that devices are registered with MHRA
  • Reporting serious risks and incidents if anything to MHRA and cooperating on CAPA issues as your trusted UK import license holder.