CE mark submission

Hi,

Need help to know :

1. The clinical trial (First in man) , 3 patients and 3 months follow up for implant medical devices, qualify for CE mark submission?

2. How to know the exact number of non-GLP animal , GLP animal and clinical trial (First in man) for the implant medical devices enough for CE mark submission ?

3. Is the non-GLP animal trial "want or need" before GLP animal trial prior to submit CE mark regulatory?

4. For clinical trial, can the inventor and PI in same person according to the CE mark regulatory ?

Thanks

 

I was involved at an implant company, and did get the CE for a new implant. But the clinical trial had been set up before I became involved.

Our device was an active implant, with substantial use being made of similarity to existing devices that the company had a long history of successfully making.

Our clinical trial (first in man) was 6 patients x 2 centres, (12 total), monitored at 6 and 12 months.

The plan was created after discussion with our Notified Body (one of the very few who have the expertise to deal with active implants) and our national Competent Authority (I'm in the UK - so that is the MHRA).
The numbers involved was thought to balance the need for enough evidence with the risk of exposing more people to an untested device.

 

Thanks.

May I know the Notified Body ? The device is invasive device long term implant (one year implant) .

The target is CE registration . Looking for the expertise of Notify Body to have the answers as follows:

1. The sample size of First in man clinical ? Minimum period of follow up ?
2. The sample size of non-GLP animal and GLP animal trial ?
3. The sample size of pivotal clinical trial ? Is require for pivotal trial ?
4. Can the inventor and PI in same person for the clinical trial ?

Thanks

 

Have you consulted EU's MedDev 2.7.4 document on clinical trials, see http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_7_4_en.pdf

Title of the MedDev: GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES