MDR/IVDR
A single device available in two versions:
• Marketed in a sterile state
• Placed on the market in a non-sterile state and intended to be sterilized before use
How many Basic UDI DI?
2
How many Certificate MDR a class III device must have ? Which one?
2 - certificate Annex IX Chapter II ( TD assessement) and Chapter I and III ( QMS)
Am I a significant or a substantial change?
Substantial
the company has 5 employees , a good standing QMS can I apply adjustement factors?
no for the moment - GMED is requesting not to apply them
Can we write a concession against regulatory provision?
never - always about our internal procedures
Recertification : is there an Renewal audit per se ?
no - It is a Surveillance audit that will be performed including additional services if needed
What should be the duration of stage 1 audit ? ( general rule)
less than 50% of duration of initial certification audit
Is complete relocation an admin change?
no - need to do an audit
MDSAP certificate for Brazil, Japan and USA, what is the longest possible duration of the certificate?
3,5 years max- 3 years max if Canada is part of the scope - see procedure 720 GMED 0901a
I am a standard created to give requirements to organization performing audit and certification of management system. Who am I ?
ISO 17021
Manufacturer are required to draft me for implantable devices and class III devices/ class C & D . Who am I?
SSCP/SSP-
Summary of safety and clinical performance
What is a certification cycle?
period during which the certificate is valid
Is removal of a site an admin change?
no - it is removal of an activity that could be considered as Admin change, depending of the context.
Device: Life supporting
Next audit: renewal
Can I conduct a remote or hybrid audit?
wrong
For all admissible complaint received, the quality department of the entity that received the complaint
drafts and sends the customer a letter of acknowledgement within 10 days, using form 720 GMED 0103-40a.
True or false?
False - it is 5 days
Is performance of testing of class III device mandatory during the certification cycle? if yes at which frequency?
yes and it is once per cycle - see procedure 720 GED 819a
How long has the NB to to verify the implementation of corrections and CA of any major nonconformity after initial audit?
within 6 months after the last day of stage 2, the certification body - otherwise NB shall conduct another stage 2 prior to recommending certification.
Company A buys a company B . Company B still exists. What is it?
Acquisition
What are the attachments to be joined with MDSAP audit report by the auditor?
4 documents
NGE form
Devices list
Critical suppliers list
Audit plan
if stage 1 --> audit report
For a complaint, who draft the final response to the complainant?
the pilot
How many clinical domains have been created?
16
Who should perform the clinical review in a case 3?
A Clinical Product Reviewer CPR and an External clinical expert - see 720 RDM 0826a
Two companies become one new company - what is called this kind of merger?
Amalgamation
In which cases do we need to use the MDSAP notification form? Mention at least 4
1. Voluntary Withdrawal of Participation in MDSAP
2. Transfers of facilities between Auditing Organizations
3. Refusal to certify (decided by GMED):
4. Withdrawal of certification (decided by GMED):
5. Suspension of certification:
6. Reduction of scope of certification:
7. Reinstatement of certification:
8. Request of reactivation of a facility profile:
9. Modification of existing data:
- Initial audit start and end dates (by more than a month)
- Facility Name
- Other Trade Name(s)
- Address changes (including campus address additions and deletions)
- Jurisdictions
- MDSAP Scope of Certification
- Certificate holder information
- Facility Contact Person
A client is contesting a notification letter following a change request. Which procedure applies? Complaint or Appeal
Appeal