CE Scope on Medical Device & Device Accessories to the Foley Catheter

M

Mor628

Hi everyone,

We sell a range Foley catheters to our customers in Australia. Some of our customers ask specifically only for spigots which is an accessory to the Foley catheter. They only want to buy the spigot on its own. This is a class 1s device.

In our CE, the scope only states Foley catheter without the word ''accessories'' or ''spigots'', but it covers the entire set (Foley catheter + accessories).

As such, our customer has had trouble registering the spigot with TGA.

What can I do to help this situation, aside from adding the word accessories to our cert during the next certification?
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: CE Scope on Device & Device Accessories

Hard to provide a generic solution. This would probably require some dialogue with the TGA - you will need to start with the EC certificate and trace back to other documents from your technical file that prove that that certificate actually covers the spigots, in the configuration being exported to Australia. Someone would have to look at the actual documents and work with the specifics.
 
Last edited:
M

Mor628

Re: CE Scope on Device & Device Accessories

Thanks for your reply :)

Will probably have a chat with TGA & our NB to see how we can go about it.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Medical Device Repairs and ISO 13485 Scope ISO 13485:2016 - Medical Device Quality Management Systems 7
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
R Does oral irrigator fall within the scope of Medical Device Directive 93/42/EEC? EU Medical Device Regulations 11
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
L Non-medical device is in the ISO 13485 audit scope? ISO 13485:2016 - Medical Device Quality Management Systems 11
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Informal vs formal scope creep... managing non-medical devices through system processes ISO 13485:2016 - Medical Device Quality Management Systems 2
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0
S Should Quality System scope cover non-medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
Ajit Basrur Scope for ISO 13485 vs. ISO 15378 - Molding Parts for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Design verification test sample size under the scope of first in human study submission in Europe Medical Device and FDA Regulations and Standards News 3
L Review of Scope of Mangement System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Adding a Processing site to scope, shipping before certification? IATF 16949 - Automotive Quality Systems Standard 2
L AS9100 work for another site outside scope AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Audit Duration Calculation - ISO9001 + EN9100 with different scope General Auditing Discussions 2
S Smart Scope Fixturing Quality Tools, Improvement and Analysis 3
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
S 7.1.5.3.1 Internal Lab Scope IATF 16949 - Automotive Quality Systems Standard 15
Tagin Corporate HQ handles AR/AP - Outsourced or Out-of-scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D API Q1 clause (1.0) Scope Oil and Gas Industry Standards and Regulations 1
Q Considering addition of mass calibration to ISO17025 scope ISO 17025 related Discussions 6
C ISO13485 scope as Legal Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H IEC 62368-1 Scope of Testing CE Marking (Conformité Européene) / CB Scheme 3
A Laboratory scope on the IATF IATF 16949 - Automotive Quality Systems Standard 5
I Restricting scope to one part number for one customer IATF 16949 - Automotive Quality Systems Standard 6
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S F-108 Request for Expansion of Scope of Accreditation ISO 17025 related Discussions 2
S Scope of management review ISO 13485:2016 - Medical Device Quality Management Systems 5
D Do all products fall under scope of AS9100? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M AS 9100 Scope for Repair Station with PMA approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
Stefan Mundt Split Scope = Separate Audits ??? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Kap.4.3 Determining the scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ERP software validation - risk assessment vs validation scope ISO 13485:2016 - Medical Device Quality Management Systems 11
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
3 Scope question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Internal Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 10
T How to handle out-of-scope activities. ISO 13485:2016 - Medical Device Quality Management Systems 7
Enghabashy Supply chain main policies ,scope, risk assessments & relavant KPI Supply Chain Security Management Systems 2
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14

Similar threads

Top Bottom