Migrating from whole product CE marking to modular approach

#1
Hello,

I work for a company which creates software that is very similar to the examples given in MDCG 2019-11 - Modules. The application consists out of many modules, from which only some have a medical purpose and qualify as a SaMD.

At present the whole solution is CE marked as a Class I device and we would like to migrate towards a scenario where only the relevant modules bear CE marking.

How would we best approach this? Can we update our existing notification and more clearly delineate and define what falls in scope or should we cancel our current CE marking and notify each of the modules as separate devices?

Any insight is greatly appreciated!

KR,
Arne
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Would these modules, in and of themselves, be considered "medical devices" (SaMD)? They are truly stand-alone?
 
#3
Hi yodon,

First off my apologies for the late reply. Some urgent matters came up.

The modules are meant to calculate new values (provide information) based upon values which are either entered by health care workers or communicated by other systems. These calculated values are either used as input for treatment parameters or to monitor treatment efficiency.

The idea would be to isolate the software libraries performing these calculations as services. This allows for a clear boundary and makes them truly stand-alone. Theoretically they could even be installed on a completely separate server.

The services would define a clear contract towards other software components, i.e. defining the possible inputs and outputs that can be expected.

Hopes this clarifies a bit further.

KR
 

yodon

Staff member
Super Moderator
#4
No worries, no expiration dates. :)

What you describe doesn't sound like SaMD but just some library functionality that multiple (?) applications could use? What "medical purpose" does your software perform?

I'll admit that the IMDRF Key Definitions for SaMD does say that SaMD "may be used in combination (e.g., as a module) with other products including medical devices" but I still think it, on its own, has to have its own medical (intended) purpose. If they're just providing calculations, I don't see that as an intended medical purpose.
 
#5
Thanks for your answer.

The intention would indeed be to isolate the calculations as libraries which could potentially be used by multiple applications.

Can you please elaborate why you do not consider these libraries not to have a intended medical purpose? The resulting value will be used as a treatment setting (e.g. a parameter entered on another device). I considered that to meet the 'intended to be used for treatment of a disease'. There is no other use for these values being calculated unless for either monitoring or treatment of disease.
 

yodon

Staff member
Super Moderator
#6
Can you please elaborate why you do not consider these libraries not to have a intended medical purpose?
To have an intended medical purpose, you have to make a claim of what it does. Then you have to demonstrate that you meet those claims. Providing input is not an intended medical purpose, IMO. Your device is not monitoring or treating. Further, your software is not stand-alone if it only provides an input.

That's just my *opinion.* I would certainly suggest you consult with a regulatory expert.
 
Thread starter Similar threads Forum Replies Date
M Switching (Migrating) to a new QMS Software Package Document Control Systems, Procedures, Forms and Templates 14
G Migrating to an ISO 13485:2016 Compliant Document Control System ISO 13485:2016 - Medical Device Quality Management Systems 6
S Migrating from paper based to electronic system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Computer System Validation - Migrating to SAP Document Control Systems, Procedures, Forms and Templates 5
V Do we need help (a consultant) migrating from AS9100B to AS9100C? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Anerol C Migrating Current Procedures to a New Procedure template - Are Approvals Needed? Document Control Systems, Procedures, Forms and Templates 7
A % of defects on the whole batch based on result from inspection under AQL Level II Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
M Software Development Company - Who would own the whole process and the certification afterwards? ISO 14001:2015 Specific Discussions 1
A How can a sample can give information about bad products in whole lot? Quality Manager and Management Related Issues 3
C Implementing ISO 9001 - Getting whole team buy-in? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
J Do any of you send the whole CQI-9 System Assessment to your Customers? IATF 16949 - Automotive Quality Systems Standard 4
D Packaging Addition - Non-sterile barrier to protect the whole package 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
S Calculating MTBF (Mean Time Between Failures) for the whole Production Unit Reliability Analysis - Predictions, Testing and Standards 2
C We supply a component & produce whole product, who requests PPAP to other suppliers? APQP and PPAP 9
P Spread for Gage R&R - Product specific or whole test range of instrument? General Measurement Device and Calibration Topics 3
G Auditor had no findings for last few years - Fed up with the whole thing... General Auditing Discussions 77
P Deletion of whole or part of document vs. ISO 9001 Clause 4.2.3c ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Wish me luck - whole week Nadcap audit... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
P Internal audit whole system in 1 year Internal Auditing 20
M Can only one group within the whole division get ISO certified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Has whole group to be TS16949 certified? IATF 16949 - Automotive Quality Systems Standard 4
M Business Plan - More than one to form the whole QS-9000 - American Automotive Manufacturers Standard 1
M R&R Studies - how many? per product? Reliability Analysis - Predictions, Testing and Standards 3
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
S Reliability issue - Frequent component failure of the product Reliability Analysis - Predictions, Testing and Standards 0
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
L 1 product multiple factories EU Medical Device Regulations 0
C Product Lifetime on Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
P API Q1 - Monogram Product & API 4F - Proof Load Test Oil and Gas Industry Standards and Regulations 3
R CE marked product sold in UK no EU rep CE Marking (Conformité Européene) / CB Scheme 2
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
Awais How to mistake proof - Shipping Orders with Shortages - Product Quantity Accountability mismatch with Job Traveller? Manufacturing and Related Processes 17
L Product and process Deviation procedure Manufacturing and Related Processes 1
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
D Dental application - medical product or not? Other US Medical Device Regulations 8
Q Product Quality vs Product Defects Manufacturing and Related Processes 4
J Verification of purchased product / supplier questionnaires ISO 13485:2016 - Medical Device Quality Management Systems 2
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Product Code 510(k) exemption US Food and Drug Administration (FDA) 1
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 2
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5

Similar threads

Top Bottom