UK Regulatory Importer for Medical Device and IVD Companies

Optimize your compliance with MedEnvoy as your UK Regulatory Importer for medical device and In Vitro Diagnostics (IVDs) manufacturers.

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Independent UK MHRA Importer Representation

Wondering why you should consider designating a UK regulatory importer? After Brexit, you must follow the UK Medicines and Medical Devices Act (MMDA). This UK regulation identifies the Importer as an economic operator which must be registered with the MHRA by your designated UK Responsible Person.

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 need to consider the role and responsibilities of the Importer in Great Britain (England, Scotland, and Wales).

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. The obligations and responsibilities of the Importer are clearly defined in the MDR/IVDR and Swiss MedDO. Although the MMDA does not (yet) specify the specific obligations and responsibilities of the Importer, it is anticipated that the responsibilities of the UK Importer are similar if not identical. Considering MedEnvoy also fulfills the role of EU Importer and Swiss Importer, we have developed a process in support of meeting the Importer regulatory responsibilities as defined in the MDR/IVDR and apply this process to verify your compliance quickly and seamlessly with the UK Importer requirements.

UK Importer for Medical Devices and IVDs

As your designated UK Regulatory Importer, we will:

Verify that devices sold in Great Britain carry, where applicable, the UKCA mark or CE Marking.
Verify the 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 storage and transportation requirements are fulfilled.
Maintain a register of complaints as required by UK reporting requirements.
Inform manufacturer if device provides serious risk or is not in conformity.
Cooperate with Legal Manufacturer and UK Responsible Person during reporting of serious incidents or risks to the MHRA; cooperate on CAPA issues.

FAQs

How are medical devices registered or approved in the UK?

Medical devices, and In Vitro Diagnostics (IVDs), are regulated by the Medicines and Healthcare products Regulatory Agency
(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.

Who can import medical devices in the UK?

An importer for medical devices and In Vitro Diagnostics (IVDs) must be located in the UK. In situations where the importer is not the UK Responsible Person (UKRP), the importer is required to inform the manufacturer or UKRP of their intentions to import the device.

Does In Vitro Diagnostics (IVDR) apply in the UK?

Yes and no. Currently the IVDR is recognized in the UK and accepted for IVD registrations by the MHRA; however, that will only last until June 30, 2023. After June 30, 2023, all IVD manufacturers will need to go through the UK Conformity Assessment (UKCA) process and obtain UKCA marking on their devices.

What is the UK Conformity Assessed (UKCA) marking?

The UKCA marking is a product marking used for certain approved products, including medical devices and IVDs. UKCA marking is used by manufacturers to show that their products conform to the UK Conformity Assessment process and have either been certified or self-certified depending on the classification of the medical device or IVD.

Who can import medical devices or In Vitro Diagnostics into the UK?

How are In Vitro Diagnostics registered or approved in the UK?

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.

Can we keep shipping to the UK with MedEnvoy as our importer even though our submitted request for a UK registration number is not yet approved?

Due to the backlog of the MHRA, it is possible for our customers to ship to the UK if they can show us that they have applied for registration before 1 September 2021.

EU Regulatory Importer

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Swiss Regulatory Importer

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India Authorized Importer

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