Systematic literature search (periodic?alternative route?)

[Pzimmermann92]

Good day everyone,

I am implementing actions on our QMS regarding the MDR gap analysis according to our MDD (legacy) device.

Regarding the Clinical evaluation, there is a need for for a literature search and review protocol + a literature search & review report.
how often should this review be performed/conducted? only when there is a need for an update of the CER where the clinical data/literature should be an input for?

Or as i have read on similar places, whenever there is new data availability, (but as it is not practicable to check everyday for new data, perhabs 2x per years is a good interval? or is it sufficient enough to perform the review @ an CER update interval (or when needed)?

Question 2: The PMS should also be kept up to date, as far as my understanding the literature search is also an input for PMS? Or is it more a good way to go, to look for literature periodically (regarding PMS activites, through a sepreate literture search (besides the search and review protocol)? just as this statement says: "Manufacturers should proactively collect PMS data from their device as well as from competitor devices. Manufacturers can do this by searching for additional literature or looking into incident databases".

So the key questions are, how often should a literature search and review protocol + the evaluation be performed? @ every PSUR and or Clinical evaluation update, or more often?

And should PMS data be searched through this protocol, or via an alternative route?

I could not find sufficient or detailed answeres over the internet so thats why i came here for some help.

Thank you very much in advance!

Best regards, Patrick Z.

 

[Raisin picker]

Literature search (and search im safety databases) is often considered to be part of PMCF. You could use the PMCF literature search for your CER update, but keep this transparent.
The frequency of literature search depends on your device (novelty, risk class, ...). You should justify the frequency in the LSP (or PMCFP), but relating it to the frequency of the PMCF report might be reasonable.

 

[Pzimmermann92]

So if i get it right, instead of conducting a literature search and review for the CER directly it could be performed under PMCF (via its own protocol and report)?

we currently stated in our PMS plan the following:

According to MEDDEV 2.12/2 rev2. there is currently no need for a PMCF as over the observation period the medium/long-term safety and clinical performance is already known from previous use of the device wherefrom the benefit/risk is not negatively affected.

Also, there was/were:

• No significant changes during the observation period have occurred;
• No product related risk present;
• No risk arising from results from any previous clinical investigation, including adverse events or from post-market surveillance activities;
• No unanswered questions of long-term safety and performance.

....... I think i will have to re-read and try to understand the overhangs between all aspects again. my current thought was:

- that the clinical evaluation has to be updated according to new MDR requirements (new plan + CER).
- in the course of data gathering for a clinical evaluation report, a literature search and review protocol + plan has to be made and conducted
- according to PMS, 2-yearly a PSUR has to be made
- and as mentioned before, no PMCF was needed.

Our product is a class IIa device (currently 93/42 EEC), but according to 2017/745 classification rules it remains a IIa product.

 

[Raisin picker]

Be aware that MEDDEV 2.12/2 only talks about PMCF studies (and might be a bit outdated, being from 2012). According to MDR, PMCF ist (almost) always required, only the procedures and methodes should be adapted to the device. Take a close look at MDCG 2020-7 (and 8).

 

[Pzimmermann92]

Thank you very much for your comment! i will sure check it out and look into it further, lets see how far i can sort things out today