Julie Omohundro Will your products "become" medical devices due to a change in some jurisdiction's (e.g., EU's, FDA's) definition of a medical device (e.g., under the new Medical Device Directive)?

Or are you making some change to the products themselves, so that they will now fall under some regulatory jurisdiction's current definition of a medical device?

Nathalie Baudry Our products become MD due to changes coming from the New directive.

CEO -Shuky- Liat Nadel-Isr.Reg.Holder Indeed.Therefore it is important to choose tge right NB

CEO -Shuky- Liat Nadel-Isr.Reg.Holder If your products will be classified as medical devices ,what matters is that you choose a good notified body which will show you the right way in order to get the ce approvals or self dec.Team NB site .

Julie Omohundro In that case, although I know a lot of people have been following the development of the new MDD closely for a long time, I think it's premature for anyone to have had experience with it. I agree that the best you can do at this point is to find a good notified body, who will give you good guidance.

I will also add my admittedly biased opinion that you would also do well to avail yourself of the services (hired or contracted) who has experience working with notified bodies.

If it is a MD, then GMP need to establish. MD regulatory jurisdiction's need to follow such as MDD and all applicable harmonized standards. Also, GMDN will come into play.

Brian Matthews If the products are to become medical devices (under the revision of the legislation?) then you will need to comply with the relevant requirements (essential requirements) of the medical device legislation.

There are some significant differences between cosmetic legislation and medical devices legislation so you will need to undertake a gap analysis.

The target will be to address how you meet the essential requirements (Annex I). If the titles of relevant standards have been published in the Official Journal (and have not been dropped from later lists) then you can choose to comply with the requirements of those standards - but check on the Annex Zs text to see any limitations. Since the requirement is to comply with the essential requirements, compliance with harmonised standards is optional.