Use the below checklist to identify your technical and quality documentation for your compliance check.
Alternatively, download and print a PDF version to fill out manually:
If you are missing any of the listed documentation above, reach out to our Medical Device Compliance Team today who will be able to support you to create these.
LFH Regulatory will act on your behalf to register your devices with the Medicines and Healthcare products Regulatory Agency (MHRA), under the UK Medical Device Regulations 2002 (UK MDR 2002) to allow you to sell your device on the UK market.
In preparation we will require the documentation listed in this checklist prior to registering your products.
If you would like us to act as your dedicated UKRP (UK Responsible Person), get in contact today.
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
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Simplify your path to compliance, reach out to our experts today!
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