What to include in a Clinical Evaluation Plan

[polish1023]

Hi all,
we are an Active implantable device in clinical study phase (pre-market). we are due to meet our NB in a few weeks and we need to present them a CEP. Does anyone have some sort of a template I can use of what information we need to include?
In addition, one of our consultants, have said that in order to get CE nowdays (last 2 years) we need to show a "performance goal" (as is common by the FDA). So its not enough to show a clinical effect, we need to show a significant clinical effect. Is anyone familiar with this?
Thanks

 

[pkost]

Re: Clinical Evaluation Plan

I'm afraid I don't have a template, I suggest you review MEDDEV 2.7.1. Appendix F is particularly useful as it shows you what the NB checks an evaluation for.

With regards to "performance goal", There has been no change to the directive in recent years, but there has been an increasing rigour of review. I imagine your consultant is refering to essential requirement 2 of AIMDD or ER3 of the MDD which essentially says that the device must be effective....

The thing about this essential requirement (and much of the directive) is that it is the manufacturer who defines the performance characteristics. You should just be able to demonstrate that the devices does what you say it can do.

 

[Pads38]

Re: Clinical Evaluation Plan

As pkost says MEDEV 2.7.1 Rev 3 is your best source of information.

As you are considering an active implant you will need to conduct a formal Clinical Investigation. This has it's own standard - ISO 14155:2011. This has a clear specification for the Clinical Investigation Plan, which is I expect what your NB wants to consider.

Clinical Investigation Plans, depending upon country, have to be approved by your National Competent Authority (in the UK that is the MHRA) and the Ethics Committee of all clinical centres involved.