Transferring your medical device to LRQA

If you are looking to transfer you medical device to another notified body, then look no further than LRQA. Our medical technical experts and industry specialists provide best-in-class medical quality assurance, CE marking product certification to MDD 93/42/EEC and IVDD 98/79/EC, and training services.

In fact, many new clients, come to us seeking to transfer their current CE marking to LRQA, and this experience has led to us creating a smooth and thorough process designed to enable a timely transfer which causes minimum disruption to you. 

Getting started – what you need 

Below is an example of the kind of information we will ask you to provide.

  • Download and complete the enquiry form  for MDD or IVD, then email it to enquiries@lrqa.co.uk , attaching the relevant documentation to your email. 
  • attach a copy of your existing certificates that are to be transferred (e.g. ISO 13485, MDD, IVDD, Design , 9001, etc.) 
  • attach your previous audit reports from the last 12 months 
  • attach your previous product assessments 
  • attach a copy of the current technical file sampling plan for class IIa / IIb (MDD devices) if relevant 

What do I do if any non-conformities exist with my current Notified Body? 

The answer depends on the type of non-conformities. If there are major non-conformities, then you will have to action them and close them before the transfer can take place. If there are minor-non-conformities, LRQA will review the corrective action plans and then, as part of the transfer process, will verify the implementation of these corrective action plans.