SBS - The best value in QMS software

SaMD - Placing on the Market before DoA

RA_QA_Expert

Involved In Discussions
#1
Hi all,

based on MDR transitional period, class I MD placed on the market according to MDD before DoA (26.5.21) can be make available on the market (distributed) until May 2025. And some manufacturers take strategy to produce devices on stock (of distributors).

What about Software as Medical Device?

SaMD cannot be produced on stock physically, so if last version of SaMD is released in compliance with MDD and legally placed on the market before DoA, can manufacturer or distributor sells copies of this SW until 2025? Or?

Thank you for you thoughs
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
That's an interesting question. I'll say up front I don't know the answer. I suppose since there haven't been any other responses, there may not be clear direction here yet.

My guess is that if you ask your NB, they may say you absolutely have to get clearance under the MDR ASAP! May be a case where you don't say anything and see if they react. You could always argue if they push back that you're not rebuilding the binaries!

That argument falls flat, though, if you need to make changes.

Have you done a gap analysis to the MDR yet? Doing that, having a plan in place, and starting to close any gaps would certainly put you in a better position either way.

Keep us posted. I'm sure that sharing anything you learn would be appreciated here.
 

Raisin picker

Involved In Discussions
#3
I'd say you can distribute it until May 2024. I would argue that you are "manufacturing" a new copy of your device once it's downloaded from your repository.
This might be different when your distributor stocks the software in their own repository, and the final download does not require any interaction from your side. Try to provide enough licence keys in advance.

Of course, there is not one correct answer, it will depend on your NB and its certification agency, and also on your device and distribution structure. You should find your own answer and document the reasoning in your system (and here, as yodon mentioned).
 
Thread starter Similar threads Forum Replies Date
D CE SaMD modular approach CE Marking (Conformité Européene) / CB Scheme 5
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
Y Distributor for a SaMD Medical Information Technology, Medical Software and Health Informatics 3
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 3
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
N Servicing for SaMD ISO 13485:2016 - Medical Device Quality Management Systems 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
N Agile SOP for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
M Informational TGA – Submissions received: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 1
D Not a SaMD - How to be submitted for marketing authorization in EU and USA CE Marking (Conformité Européene) / CB Scheme 5
T Medical device or not - SaMD Other Medical Device and Orthopedic Related Topics 3
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
M Informational TGA Consultation: Regulation of software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
R SaMD - Software as a Medical Device - Software change control form ISO 13485:2016 - Medical Device Quality Management Systems 3
M Medical Device News Health Canada - Scientific Advisory Panel on Software as a Medical Device (SAP-SaMD) - Record of Proceedings – January 26, 2018 Canada Medical Device Regulations 0
K Registering a Software medical device (SaMD) in China China Medical Device Regulations 5
C Supplier Assessment for Hardware supporting SaMD ISO 13485:2016 - Medical Device Quality Management Systems 1
T MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41 Other Medical Device Related Standards 3
M IMDRF document - Application of QMS to SaMD ISO 13485:2016 - Medical Device Quality Management Systems 2
W IEC 62304 vs. IMDRF SaMD Guideline Risk Class IEC 62304 - Medical Device Software Life Cycle Processes 5
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
N When is "placing on the market"? MDD certified medical devices EU Medical Device Regulations 32
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
D ROHS 2 - Medical Device: Placing vs Making Available on the market EU Medical Device Regulations 3
R RoHS and placing on the market in Non EU countries RoHS, REACH, ELV, IMDS and Restricted Substances 3
C Medical Device Marketing vs. Placing Product on the Market EU Medical Device Regulations 8
C What is "Placing on the Market" in EU? Brochures or Install? CE Marking (Conformité Européene) / CB Scheme 6
G Placing a dollar value on our QMS (we are looking at IP protection) Quality Manager and Management Related Issues 3
C Reducing paperwork and placing in Systems electronically - Electronic documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Automated Processing and Placing Parts Manufacturing and Related Processes 4
J How can I evaluate a new supplier prior to placing an order? Supplier Quality Assurance and other Supplier Issues 7
A Ownbranding or placing on market without CE mark ISO 13485:2016 - Medical Device Quality Management Systems 7
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
D Economic Operators, EU Market Access EU Medical Device Regulations 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
R Information on obtaining a market authorization for China China Medical Device Regulations 2
M EU MDR - Labilities when a device is discontinued from the Market EU Medical Device Regulations 1
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
F When to market and distribute device in EU? EU Medical Device Regulations 3
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
T Modification of a product on the market EU Medical Device Regulations 2
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1

Similar threads

Top Bottom