Adding "new" medical device to existing CER - under MDD

[PVC Barbie]

I'm trying to determine the best route for adding "new" medical device to an existing CER and I'm hoping the technical writing experts have some suggestions. Writing/research for existing CER was outsourced about 18 months ago. Device is Class IIa under MDD.
The new device can be considered as an equivalent device (meets required criteria - biological, technical and clinical) and we are the manufacturer of both devices (hold tech files for both devices). The new device has the same intended use, design, target population and essentially same principles of operation, it only has a few minor variations.
My questions are:
1. Is it OK to add a new and not yet marketed device to an existing one for a device with long market history when the device can be considered an equivalent device?
2. If yes, would an update to the entire CER be necessary to incorporate the new device OR is an addendum to the "Equivalent Devices" section sufficient, provided that it touches on the key similarities/minor differences and justifies them?
3. Is a new literature search necessary if the original CER was not set to be updated for another 18 months and the new device has not yet been marketed (provided no new risks have been identified)?

 

[Ronen E]

Writing/research for existing CER was outsourced about 18 months ago.

Hopefully is was outsourced to someone you trust - why not ask them? Much better informed than us here.

1. Is it OK to add a new and not yet marketed device to an existing one for a device with long market history when the device can be considered an equivalent device?

Probably yes, but don't just gloss over equivalence. You have to thoroughly substantiate it.

3. Is a new literature search necessary if the original CER was not set to be updated for another 18 months and the new device has not yet been marketed (provided no new risks have been identified)?

These intervals sound awfully long to me. In the EU you are expected to keep your technical documentation at par with the state of the art, CER included. I think once a year is prudent (in some cases 6 months), and 18 months is quite marginal, unless it's a very mature, and quite clinically stagnant technology / field of application. 3 years is not acceptable, I would think. This is regardless of adding the new device, I'm referring to the existing one. The addition of the new device is a good opportunity to fix this.