Using non CE parts in a machine

#1
Can I use non CE marked parts in a Machine? Some smaller parts (terminal blocks) do not have much for certification, possibly UL reconginzed by no CE.

This is a non-medical device. Do you have any guidance?

Thanks in advance!!!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Generally speaking, the principles of CE marking ("The New Approach", see The Blue Guide) don't require CE marked components inside a product intended to be CE marked. However, there might be requirements specific to the field / industry / type of product, that stem from all sorts of other sources.
 
Thread starter Similar threads Forum Replies Date
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
A Overkill? Using the 3L5W tool on non-conformities Nonconformance and Corrective Action 3
S Using Calibrated OD mic over non-Calibrated ID mic for final dimension Manufacturing and Related Processes 17
A R using RExcel - Non GUI Statistics Program Statistical Analysis Tools, Techniques and SPC 1
M Is using different company logo a non conformance in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Non-Replicable MSA when using digital multimeters or oscilloscopes Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
D Supplier Conformance - Using non-certified suppliers - TS 16949 IATF 16949 - Automotive Quality Systems Standard 8
R Non Destructive Testing of plain Carbon steel castings using Eddy Current Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S 21CFR820-820.50 Purchasing controls - Using Non-Approved Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
K Using an "obsolete" test method - TS 16949 Audit Non-Conformance General Measurement Device and Calibration Topics 13
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 4
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
Z Using FMEA for Knowledge Management FMEA and Control Plans 6
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
J Including Repeats in DoE using Minitab Using Minitab Software 5
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
John Predmore What size pinhole can be reliably detected using visual inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8
John Broomfield Workplace by Facebook - Any other organizations using this collaborative tool? Misc. Quality Assurance and Business Systems Related Topics 0
I Flatness - Rectangular part using the three jack method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
JoshuaFroud How important is using the "correct" GMDN? Other Medical Device Regulations World-Wide 5
M GD&T tolerance or band? Using a symbol like parallelism // Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
B Informational Expanded Gage R&R Analysis using Minitab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 18
S Evaluating the possibilities of using qmswrapper or greenlightguru Document Control Systems, Procedures, Forms and Templates 4
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
V Using K-Factor(Tolerance Interval) Analysis for Design Verification Statistical Analysis Tools, Techniques and SPC 3
O Which is better - Quietly quit using a supplier or tell supplier? Supplier Quality Assurance and other Supplier Issues 11
A Capability Analysis for Packaging Seal Strength with spec. >0.1 Kgf using Minitab Using Minitab Software 6
J Layered Process Audits using Kamishibai Board Process Audits and Layered Process Audits 3
Q How can you justify using a more accurate Pin Gage class? General Measurement Device and Calibration Topics 16
Similar threads


















































Top Bottom