UK Responsible Person Toolkit

Avail a complete set of guidance documents, templates and exhaustive checklists to ensure successful device registration

12+ documents
for UK Responsible Person
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guidance for adaptation
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Freyr Appointed as a UK Responsible Person for a French Device Manufacturer

Learn how Freyr helped a France-based medical devices company specialized in design,
manufacture and marketing of device products.

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  • End-to-end UK Responsible Person Services
  • Highly experienced professionals acting as your UK Responsible Person
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With a few simple steps setup end-to-end Regulatory support for registering and marketing your Medical and In-Vitro Devices in the UK

 
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Nisha Vempalle

Director, Medical Devices- UK

 

Your UK Responsible Person Expert

Nisha Vempalle leads Medical Devices Regulatory operations in UK and EU in Regulatory Readiness, Strategic planning and being Project delivery spearhead. She has more than 15 years of experience across Regulatory Affairs-delivering Global Innovation Projects, Regulatory strategies, leading Regulatory Projects to successful approvals and launch in Medical Devices.

Her core strength is the deep understanding of Medical Device Regulatory landscape in UK and EU regions apart from her International expertise including Asia, Africa, Middle East and South America. She has wealth of experience from her previous roles at PAGB, GlaxoSmithKline and Biocon spanning more than a decade. Nisha is a Pharmacist and holds a masters degree in Pharmaceutical sciences from Kingston University and RAC-EU & Global certified professional.

 

Frequently Asked Questions

It is a folder with 10 separate documents required to set up the UK Distributor/Importer/manufacturer as a UK Responsible Person.
The UK Responsible Person Services are made available from Jan 1, 2021.
Service agreement, letter of designation, review of technical documents and registration with the MHRA are some of the critical steps to be followed by a manufacturer to become a UK Responsible Person.
You can change your UK Responsible Person at any given point of time and a UK Responsible Person would notify the MHRA about termination of services.
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