Regulatory Approval for similar Medical Devices


Trusted Information Resource
Hi All,

If I wish to submit two identical medical devices for regulatory approval (class II in Europe) differing only in size, would I have to submit 2 separate applications or can they be treated as one and it's variant? The devices in question are catheters for insertion during laparoscopic procedures.

Thank you in advance,



Re: Regulatory Approval for similar devices

I would have thought that it would be no problem if you can cover both in one Technical File i.e. a ?family? of like products. I have had no problems with our NB with variants in my TFs which cover items of different design but which do essentially the same job.

Top Bottom