Quick due dilligence checklist for non-integral DDC

Pharmaceutical companies that want to place a non-integral drug-device combination on the EU market need to work together with a medical device manufacturer. The device must be CE-certified for the right intended purpose before the market authorization application can be filed. Therefore, it is important for the drug company to keep sufficient control over the medical device conformity assessment procedure. The checklist can provide an indication of the progress of this certification process.

Application form

Company data

Company name

Company address

Number of employees

Invoicing email address

VAT number

PO number for the training

PRRC data

First name

Middle name

Last name

Function

Teammember

PRRC email address

Phone

Country

City / timezone

PRRC role

PRRC role

PRRC specific topics

PRRC topics

Optional mailing list

Do you want your name and email address to be share with the other participants in the training? If you agree you will be added to a group mailing list, if you don’t agree or you don’t indicate anything, you will receive the same messages individually.

On mailnglist

Yes, please add me to a group mailing list of this training

Optional coaching

For PRRCs that want additional personal training, there is the option of booking this together with your training. For most PRRCs 2-5 hours will be adequate.

Option coaching

Yes, I opt in for personal coaching

Thank you for your application.

You will soon receive a confirmation in your mail. If not, check your spam or mail me.

Quick due dilligence checklist for non-integral DDC

Application form

Share this!