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 firstname.lastname@example.org , 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.