Medical Device conundrum

[Danny92]

Hello,

Me and my partner are currently developing a medical device that will primarily be used by women after giving birth. Although we are pretty certain the product falls under class 1 due to the low risk however in order for us to make full claims in our marketing it seems like it will have to be approved under classification 2. I have done a fair bit of digging on the internet, reading documents on MHRA/FDA website along with some threads on reddit and other forums including this and so far I have come across some examples of drugs and other types of medical device but not quite like ours. We are both not well versed in any of this and just don't really have the time to get through all the paper works on their websites due to being swamped with other parts of the projects so any help would be amazing.


My questions are ;
1. Has anyone been through a Class 2 approval process for either the MHRA or FDA in the past? Could I get a rough summary on what the process is and what is consists of?
2. We are on a budget so trying to do most of this on our own, is it worth getting a consultant of some sort to deal with the approval side of things?
3. Has anyone been involved with doing a clinical trial or a case study of their medical device in the past to see the efficacy?
4. Would a MHRA Class 2 approval quicken up the process to achieve the same with the FDA?


Just wanted to say this forums been absolutely amazing, we would be nowhere near where we are with this project if it wasn't for this forum.

Thank you

 

[jlai928]

Hey there, not sure if you have your answer, I know it's been a while.

I'm a Quality and Regulatory Engineer and have worked with several medical device companies.
Look into ISO 13485. By meeting the criteria in that standard, many of your requirements for MHRA and FDA will be met barring the specific regulatory requirements that are country dependent.

For class 2 you will need to get CE marked if selling in Europe and need to involve an entity called a notified body to assess your quality management system (ISO 13485). It is the UKCA in the UK and there are several pathways for FDA s uch as 510k or de novo.

I would start with the UK so that will be the UKCA. Registration with MHRA is step one then getting certified to ISO 13485 and getting it UKCA marked. If you can get away with class 1 non-sterile, that will be 'easiest' provided you have ISO 13485. Class 1 non-sterile don't need notified body approval, just a declaration of conformity and the normal requirements such as technical file etc.