UK MHRA Compliance and EU CE Marking for Simple Software

I am the co-owner of a small company that teaches people how to do EMDR Eye Movement Therapy on their own.

Our company, Virtual EMDR, offers a step-by-step Eye Movement Therapy program (EMDR) and includes audio and visual software.

Here is a link to a short video on our You Tube channel that explains our product and shows our software. (The video says "in-development" but we are done and have launched) [login to view URL]

We want to offer self-administered EMDR to a partner in the UK and Europe, but they said that we need a CE marking and also MHRA medical device guidelines.

I tried reading the document from the UK government about MHRA compliance but there was so much legal speak that I really felt lost.

I want to hire a compliance expert to help me navigate this process.

I have a document (attached) with the regulations we have to meet for CE marking, plus I am told we will have to follow BS EN 62304:2006+A1:2015 Medical device software. Software life-cycle processes.

I had an expert tell me that the CE Marking process was "easy" but that I would need an authorized representative in the UK.

He went on to say that Virtual EMDR is "Class 1" so it doesn't not need the full exhaustive registration and testing process.

Lastly, he mentioned that insurance companies would ask for a "declaration of conformity."

Honestly, I am not even sure what all this means.

-Can you advise me on how to move this process forward?

-Can you advise me of an approximate cost to do this process?

-Is there anyone I can call to help guide me? Or can you refer me?

Skills: Compliance, Compliance and Safety Procedures Writer, Compliance and Safety Training, Health Care Management, Legal, Paralegal Services

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