Optimize your compliance with MedEnvoy as your UK MHRA Importer for medical device and In Vitro Diagnostics (IVDs) manufacturers.
Meet UK Requirements Quickly and Seamlessly with the Regulatory Experts
Independent UK MHRA Importer Representation
from the #1 Regulatory Importer
Wondering why you need a UK regulatory importer? After Brexit, the UK is no longer required to adopt European medical device regulations. That means the EU MDR and 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.
Regardless of whether you are selling legacy devices holding existing CE certificates under the MDD/IVDD, or devices with CE under the MDR/IVDR, or you already have UKCA marking, you still require a Great Britain importer based in the UK.
Your Sole UK Importer for Increased Independence and Compliance Verification
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 also fulfills the role of EU importer and Swiss importer, so we have processes established to verify your compliance quickly and seamlessly with the UK requirements.
As Your Designated UK Regulatory Importer, We Will:
- Verify that devices sold in Great Britain carry the UKCA mark
- Verify UK declaration of conformity and technical documentation
- Verify labeling, UDI, and accompanying information (IFU)
- Check to ensure that the 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 or 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
Would you like to discuss with an expert or get a quote?
65+ Medical Device & IVD Manufacturers Trust MedEnvoy as Their UK Regulatory Importer
Tower Bridge, London
Frequently Asked Questions About Requiring A Regulatory Importer in the UK:
(MHRA). Since January 1, 2021, the MHRA has made significant changes to how medical devices and IVDs are regulated in the UK. The most important change is that all devices must be registered with the MHRA before they are placed onto the market. For manufacturers outside the UK, a UK Responsible
Person (UKRP) must be appointed to act and register on behalf of the manufacturer.
Prior to formally registering, all manufacturers will either need to have Conformitè Europëenne (CE) Marking, which will be recognized by the MHRA until June 30, 2023, OR obtain UK Conformity Assessed (UKCA) Marking.
their intentions to import the device.
IVDs are regulated in the UK. The most important change is that all devices must be registered with the MHRA before they are placed onto the market. For manufacturers outside the UK, a UK Responsible Person (UKRP) must be appointed to act and register on behalf of the manufacturer.
Prior to formally registering, all manufacturers will either need to have Conformitè Europëenne (CE) Marking, which will be
recognized by the MHRA until June 30, 2023, OR obtain UK Conformity Assessed (UKCA) Marking.
The Third Party Manufacturer could instruct their UK Responsible Person to have them register your company with MHRA as an Importer of their devices. Or if the Third Party does not have appointed an UK Responsible Person and Importer, you could take on both roles as well and register the device and your company as the UK Responsible Person and Importer (with Third Party Manufacturer approval). Again if the Third Party does have appointed a UK Responsible Person, it will be their responsibility to register your company as the Importer with MHRA.