EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean?

[ShRam]

Hi,

In EU MDR, Annex XIV-Clinical Evaluation Plan says, "a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects"

What do these methods mean?

TIA!

 

[shimonv]

methods is the procedure.... plan, sample size, inclusion, exclusion, protocol, instrumentation, monitoring, etc.

 

[Biomedical_engeener]

Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.

 

[Ronen E]

Clinical evaluation is required for all devices subject to either the MDD or MDR, at all times (needs to be kept up to date).

 

[ShRam]

Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.

Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation. Clinical investigations that are done after your product is placed in the market is Post Market Clinical Follow up (PMCF).

 

[Ronen E]

Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation.

Should be: Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation investigation.

 

[Biomedical_engeener]

Following previous question: What is the difference between Clinical Evaluation Report and PSUR ( Periodic Safety Update Report ) ?

 

[Ronen E]

Clinical evaluation: Article 61 and Annex XIV
PSUR: Article 86

 

[chris1price]

The Clinical Evaluation Report is prepare up front and is needed to get the CE Mark certification, The PSUR and PMCF are summaries of data collected after sale.

 

[Philip B]

Recommend you read the MEDDEV guidance on clinical evaluation (2.7/1 rev 4), we based ours on this. It's a lengthy and detailed document so you need to put aside considerable time for this. If you meet the MEDDEV there is a presumption you meet the regulation.