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UK Responsible Person
Why You Now Need a UK Responsible Person
The UK no longer needs to comply with European medical device regulations thanks to Brexit. This means that the EU MDR and IVDR regulations no longer apply. Instead, medical device & IVD manufacturers must comply with the UK Medicines and Medical Devices Act (MMDA). The MMDA legislation requires IVD & medical device manufacturers without an office in the UK to appoint a local representative, a UK Responsible Person (UKRP). Your UKRP is the person who will be responsible for managing your medical device registration, building relationships with any relevant importers and liaising with the MHRA on your behalf.
MedEnvoy can act as your importer in the EU, UK and Switzerland!
UK Responsible Person Responsibilities
The UK MMDA requires you to appoint a regulatory compliance importer for shipments to Great Britain. We can assist with this and perform the following mandated tasks:
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate the risks posed by a medical device, or if this it not possible, to mitigate them
- Ensure the compliance of declaration of conformity and technical documentation
- Immediately inform the manufacturer of any complaints or reports from medical professionals, patients or users about suspected incidents relating to devices we have been appointed to represent
- Keep copies of the technical documentation, the declaration of conformity, and relevant certificate (if applicable), including any amendments and supplements for inspection by the MHRA.
- Provide the MHRA with all the documentation and information needed to demonstrate the conformity of the device with their regulations
- Verify that the UKCA mark is carried on any device to be sold in Great Britain
- Verify UK declaration of conformity and technical documentation
How the UK Responsible Person Process Works
MedEnvoy has developed a process that prevents duplication of efforts among your UK Responsible Person and UK distributor(s). We utilize technology to ensure ongoing compliance with MHRA regulations.
For maximum efficiency, we will work with you to develop contractual arrangements and QMS procedures to prevent redundant activities from being performed while ensuring your compliance with MHRA regulations.
Responsibilities specific to you will be established and supported by procedures and work instructions that MedEnvoy will co-develop with you during our onboarding process. This will ensure speedy compliance checks and an uninterrupted flow of product shipments into Great Britain.
Have a subsidiary in the UK?
Manufacturers with an established legal entity in the UK can designate that entity as their Importer. MedEnvoy can provide “white label” back office services to your UK subsidiary to ensure all UK MHRA importer obligations are being met. Your subsidiary name goes on your labeling as importer!
Benefits of Selecting a UK Responsible Person
- Your Importer must be identified on your product labeling. You maintain the flexibility to change distributors without reprinting all labeling.
- The importer must have permanent access to confidential technical documentation. We have no commercial interest in your devices but distributors certainly do.
- Having one company act as your single Swiss, EU and UK importer will streamline the management of contracts, labeling, shipping and overall compliance for all devices sold throughout Europe.
In-country AR Fee structure
Our Authorized Representation services are provided for a flat annual fee, regardless of the number of devices.
- Technical File review fee (one time)
- Annual representation fee
NOTE: If you also work with MedEnvoy as your Importer, we can offer a multi-service discount.