Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient?

CPhelan

Starting to get Involved
#1
We have received ISO13485:2016 certification and we are heading towards our FIH human clinical trial. Prior to reaching out to our notified body I just wanted to check with people who might have gone a similar route.

With ISO13485 certification, clinical data and an agreement on device classification is this enough without requiring our QMS to be audited against MDSAP?
 
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indubioush

Quite Involved in Discussions
#2
MDSAP is an audit program to show you meet regulatory requirements from different countries. If you are just going for CE mark, you will have to show that your product meets the essential requirements, your quality system conforms to ISO 13485:2016, and you have the appropriate technical files. MDSAP is not required for CE Mark.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Good advice above.

If you're going for clinical trials in the EU, there's a relevant section in the MDD (currently applicable) as well as in the MDR (taking over). Look for "Clinical investigation".

If the trials are planned elsewhere, you need to ensure you adhere to the requirements that apply there for trials, as well as ensure that the clinical evidence you're going to collect will satisfy the MDR's requirements (worth bringing it up with you NB early on).

Unfortunately ATM the EU is not participating in MDSAP (only an observer).
 

CPhelan

Starting to get Involved
#4
Thanks Ronen. We are having a meeting with our notified body in two weeks prior to the clinical trial beginning to ask about our pathway for CE marking. Our clinical trial is taking place outside the EU so I will make a note MDR with our NB.
 

SKM.Sunil

Involved In Discussions
#6
Thanks Ronen. We are having a meeting with our notified body in two weeks prior to the clinical trial beginning to ask about our pathway for CE marking. Our clinical trial is taking place outside the EU so I will make a note MDR with our NB.

I suggest you to go through ISO14155(GCP for Clinical trial in Medical Devices), once before meeting your NB. because the trial compliance with this standard can be transferred to the European population for your CE marking requirements.
 
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