MDR – Article 120 – Transitional provisions

#1
Hi all,

Guidance on significant changes regarding the transitional provision under Article 120 describes if a design change is significant or not.
But what if you decide to introduce for example a Bluetooth or Wi-Fi connection to the otherwise offline product?

Best regards
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#2
Did you check MDCG 2020-3? My gut feeling: If you just enable an already existing but previously blocked option, this might fall under minor change. If you introduce this with new hardware and/or software, then -->MDR.

ADVICE: Discuss with your NB as soon as possible. They will have to approve your reasoning in the end.
 

shimonv

Trusted Information Resource
#3
That is a little tricky because you are introducing new risks for cyber security, new hardware and a new software build that supports wireless communication. If you have a good relationship with the notified body, it's best to ask. Otherwise, you can go through MDCG guidance flowchart and build a good regulatory assessment around it.

Shimon
 

paris

Registered
#4
hi every body
I have question about changes in medical device, as you know under MDD we report any changes to N.B and after approval implement changes whether substantial or not. now according to article 120 of MDR and its guide lines, the significant changes will make MDD certificate invalid. but I dont know shall I report any changes to N.B? or just significant one?
im a non-EU manufacture, so who is my CA? is it CA of Authorized representative?
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
We made a memo template that goes through the decision tree from MDCG 2020-3 to inform us when we have made a substantial change.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#8
This is the main portion

Guidance Ref. No.
Question
Answer
Rationale
MAIN SECTION
Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

A
Change of the Intended Purpose?
Yes -See Section A / No – See Question X
No

X
Design change related to corrective actions?
Yes - Non-significant change per MDR Art. 120(3) / No – See Question B
No

B
Change of the design or performance specification?
Yes -See Section B / No – See Question C
No

C
Software change?
Yes – See Section C / No – See Question D
Yes

D
Change of Material?
Yes – See Section D / No – See Question E
No

E
Change of terminal sterilization method of device or packaging design with impact to the sterilisation?
Yes – See Flow Chart E / No – Non-significant change per MDR Art. 120(3)
N/A
Device is not Sterile
SECTION A – Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

A1
Limitation of the Intended Purpose?
Yes – Return to main chart question X / No – See Question A2
N/A

A2
Extension or change of the Intended Purpose?
Yes - The change is considered Significant per MDR Art. 120(3)/ No – See Question A3
N/A

A3
New user or patient population?
Yes - The change is considered Significant per MDR Art. 120(3)/ No – See Question A4
N/A

A4
Change of clinical use in anatomical site, access site or deployment metods?
Yes - The change is considered Significant per MDR Art. 120(3)/ No – Return to main chart question X
N/A​

SECTION B – Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

B1
Does the change require further clinical or usability data to support safety and performance? Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question B2
N/A​

B2
Do new risks require control measures or are existing risks negatively affected? Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question B3
N/A

B3
Change of built-in control mechanism, operating principles, source of energy or alarms?
Yes - The change is considered Significant per MDR Art. 120(3) / No – Return to Main Chart Question C (or move directly to E if Chart D was previously used)
N/A

SECTION C – Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

C1
New or major change of operating system or any
component?​
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C2
No

C2
New or modified architecture or database structure, change of an algorithm?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C3
No

C3
Required user input replaced by closed loop algorithm ?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C4
No

C4
New diagnostic or therapeutic feature, or new channel of interoperability?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C5
No

C5
New user interface or presentation of data?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question C6
No

C6
Minor Change?
Yes - Return to Main Chart Question D / No – The change is considered Significant per MDR Art. 120(3)
Yes

SECTION D – Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

D1
Change to a material of human/animal origin including addition of new materials?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question D2
N/A

D2
Change to a material containing a MS or to th MS itself or, a change which may impact the quality, safety or efficacy of a MS?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question D3
N/A

D3
Changed ingredient or material from existing supplier meets existing specification?
Yes – Return to Main Chart Question E/ No – See Question D4
N/A

D4
Ingredient or material from new supplier meets existing specification?
Yes – Change to be assessed in
Accordance with Chart B/ No – The change is considered Significant per MDR Art. 120(3)
N/A

SECTION E – Design Changes and Changes of the Intended Purpose
Which may be Considered “Significant“ When Interpreting the First Sentence of MDR Art. 120(3)

E1
Change of terminal sterilization method?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question E2
N/A

E2
Design Change which affects or changes the sterility assurance?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question E3
N/A

E3
Change in packaging design which affect functionality, safety, stability or seal integrity?
Yes - The change is considered Significant per MDR Art. 120(3) / No – See Question E4
N/A

E4
Shelf-life change validated by protocols approved by the notified body?
Yes - The change is considered a non-Significant change per MDR Art. 120(3) / No – The change is considered Significant per MDR Art. 120(3)
N/A

END OF SIGNIFICANT CHANGE DECISION MATRIX
 
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