Does a CE mark infer meeting all applicable standards?

#1
I'm trying to determine what is required to CE mark an earphone.

I know that there are some applicable directives like RoHS, and REACH that we will meet, but there's no applicable product directives that I know of.
Does placing a CE mark on our product indicate that we meet other applicable standards like EN 50332 or IEC 60268-7?
 
Elsmar Forum Sponsor

CharlieUK

Quite Involved in Discussions
#2
A CE mark indicates that a product meets all applicable CE marking Directives

It says nothing about non-CE marking Directives (such as GPSD, REACH and WEEE) and nothing about standards, as standards are "only" one way to demonstrate compliance, and are only ever part of the story anyway (ongoing production quality control being another part that many people forget about)
 
#3
To be fully correct:
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
 

CharlieUK

Quite Involved in Discussions
#4
To be fully correct:
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
I wouldn't say that was being "fully correct", though you are quoting direct from CE marking - Internal Market, Industry, Entrepreneurship and SMEs - European Commission
:)
Its' worth remembering, that may standards set minimum requirements, so I'm not quite sure where the EU gets "high...…"
Or maybe I'm just a bit cynical after working in this field for 25 years :)
 
Thread starter Similar threads Forum Replies Date
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
O Private label issues For EU - Customer does not have CE Mark CE Marking (Conformité Européene) / CB Scheme 7
B What is the implication for someone who does not meet the 70% pass mark for QMS-Lead. Professional Certifications and Degrees 2
B Does Saudi Arabia mandate that a CE Mark for a Medical Device is Required? Other Medical Device Regulations World-Wide 10
B Does a Medical Device Battery need CE Mark CE Marking (Conformité Européene) / CB Scheme 20
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 35
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 21
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 28
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
G Does pitch/increment/resolution of a ruled scale apply to measurement uncertainty as line item? Measurement Uncertainty (MU) 10
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
R When does the FDA consider a component a medical device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
DitchDigger Boston Fire Code: Who Does What? (CAL TB 117-2013; CAL TB 133) Occupational Health & Safety Management Standards 2
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
C Does ITAR apply to Exporters only? Other ISO and International Standards and European Regulations 6
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 1
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
R Does an RMA = a Customer Complaint Customer Complaints 4
Similar threads


















































Top Bottom