Monitors supplied with software EU

KhPat

Starting to get Involved
#1
Hello,

How are monitors/tablets which are being used to upload software onto regulated according to MDD/MDR, the tablets itself are not medical devices and the labels affixed on them are from the original manufacturer as we do not alter anything other than upload the software. Its a bit confusing on why they would be considered a "device", anyone have any insight, useful resources or tips in case they have ran into a similar incident.

I tried to contact my notified body but no response yet.
 
Elsmar Forum Sponsor

KhPat

Starting to get Involved
#3
Tablet with the software already installed. So the tablet + software would be considered the medical device, but what if the tablets itself have not been MDR/MDD certified?

Previously when we used to add labels onto the tablet, we were asked to remove them post an audit as the tablets were not manufactured by us.
 

L_O_B

Involved In Discussions
#4
That is a common issue and I see why you were asked to remove the additional label from the tablet.

I assume that the tablet is end user ready on its own. It has a CE mark (at least according to the low voltage and electromagnetic compatability directives) and is accompanied by relevant information from its manufacturer. Therefore it is a product in conformity with legislation that applies to it.
Your software is a device within the meaning of MDR article 1(4). From a regulatory perspective you must provide hardware specifications for your software to run on. Instead of just providing this information, you decided to restrict your device to only be used with a specific hardware (probably because of safety and/or convenience reasons). This restriction is not sufficient to make the tablet a medical device.
Each device is a product but not each product is a device within the meaning of MDR article 1(4).

In your scenario you have a 'device' (your software) and another product in conformity with legislation that applies to this product. You combine them to be used within a medical procedure.
In theory, I see two options here. You may apply article 22 and claim this combination to be a system. You still have to evaluate the tablet to be suitable in this context, but I expect you already did this.
The other option would be to treat the combination as a new device. In that case, the manufacturer of the tablet should be treated as an outsourced production process. You would need the whole documentation and ensure control over the production process. I do not expect this to be feasible.
 

KhPat

Starting to get Involved
#5
Sidetrack to another question... do devices placed on the market with HC and FDA need to be the same as EU, for example if you have 4 individual devices (software and sensors) on the FDA and HC market but for the EU you combine all these into one software and corresponding sensors is there is issue with this if necessary verification and validation is conducted?

Will distributors in the EU and other countries who ask for CE certificate have issues as currently they would have each device registered individually?

I look forward to hearing your thoughts and opinion on this. Thank You!
 
Thread starter Similar threads Forum Replies Date
Q EU Regulations for OTS and System (Monitors and Scanner) EU Medical Device Regulations 3
B Hospital Wall Mounts (for Display Monitors and other devices) - Requirements Occupational Health & Safety Management Standards 10
R Documented Procedure for the Calibration of Pulse Current Monitors/Tranformers General Measurement Device and Calibration Topics 4
A Are Heart Rate Monitors used in Wellness Environments considered Medical Devices? EU Medical Device Regulations 13
C Has anyone ever heard of Informance software? Monitors machine uptime/downtime (OEE) Preventive Action and Continuous Improvement 11
M Classification of a disposable Screen Pointer for use by surgeons on monitors? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
BradM Running two monitors on one computer - Dual View After Work and Weekend Discussion Topics 9
R EC11 - Guidance Document - FDA 510 (k) Submission - ECG Monitors 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
J 7.4.2 Purchasing information - Computer monitors ordered on the internet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Needed but not supplied CE Marking (Conformité Européene) / CB Scheme 0
BusyBee IVD components supplied in bulk CE Marking (Conformité Européene) / CB Scheme 1
JoeRandom11 Question about Customer Supplied Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q BMW Supplied Parts Quality Management -> Is there any new supplier quality manual? Customer and Company Specific Requirements 0
M Supplied Goods out of QMS / DtS? ISO 13485:2016 - Medical Device Quality Management Systems 3
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
D Supplied Product on Control Plan - Lot ranging in 40,000 pcs per product FMEA and Control Plans 3
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
D Supplied item design verification Supplier Quality Assurance and other Supplier Issues 5
Manix Supplied Steel Material Testing Norms and Requirements Supplier Quality Assurance and other Supplier Issues 1
R Customer supplied material - risk and policy advice needed Quality Manager and Management Related Issues 11
R Deciding if a medical device shall be supplied sterile or not Other Medical Device and Orthopedic Related Topics 5
D Sampling method that is representative of the devices supplied by that distributor EU Medical Device Regulations 5
R AS9102 FAI with No Drawings Supplied AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J API Q1 5.6.1.2 (iii) Identifying how the supplied product conforms Oil and Gas Industry Standards and Regulations 1
A Identification of Customer Property: Customer-Supplied Thumb Drives & Ext Hard Drives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Gman2 Coating Company, ALL customer supplied product? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Creation of CAD solid models using customers supplied drawings AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
R What objective evidence can/can't be supplied during a customer audit? General Auditing Discussions 3
T IMDS - MDS request for parts supplied to multiple customers RoHS, REACH, ELV, IMDS and Restricted Substances 15
N What is the easiest way to verify we have the correct customer supplied materials? Misc. Quality Assurance and Business Systems Related Topics 5
I Implant Raw Material Supplied from Customer to Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
J CMM calibration using a perfect sphere that is supplied Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
S How can I inventory labels supplied by customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Procedure for Handling of Customer Supplied Material (AS9100 Requirements) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S ISO 9001 Section 7.6 - Customer has supplied torque specifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
L Sample of Solder supplied with PCB by supplier - What is this sample for? Manufacturing and Related Processes 9
R CAD Print Conflicts with the Customer Supplied Paper Drawing Manufacturing and Related Processes 19
P ETO Sterilisation of Single Use Part supplied in Non-Sterile State EU Medical Device Regulations 12
N How to apply Incoming (Receiving) Inspection to Customer Supplied Material? IATF 16949 - Automotive Quality Systems Standard 18
B Supplier Quality vs. Supplied Material Quality ISO 13485:2016 - Medical Device Quality Management Systems 9
A Customer Supplied Product & Certifications - Drop Ship - FDA and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
B Customer supplied product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
H Can the documents supplied by the client categorised as customer property?? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Calibration through Gage Blocks/Test Fixtures/Customer Supplied ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H What can be customer supplied properties (property) for the software industry? Software Quality Assurance 18
I Traceablity of Small Part Lots Supplied to Production taken from Large Lots? Lean in Manufacturing and Service Industries 7
C Customer Changes to Customer Supplied Documents - Testing Instructions US Food and Drug Administration (FDA) 2
B PPAP approval based on information supplied by the supplier APQP and PPAP 2
L PPAP Part Supplied to Multiple Plants - Submit another PPAP or PSW to the new plants? APQP and PPAP 6
A Lot Number Assignment for Incoming Purchased Products and Customer Supplied Material Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom