SBS - The Best Value in QMS software

EC REP information and CE Mark - Component of a system that is not a medical device

JB0424

Starting to get Involved
#1
I joined a company not long ago. The company markets an old electrosurgical system that includes a cart with its own SKU. The cart is not considered a medical device. The label for the cart lists the EC REP and no CE mark. Is this correct?

Does the EC REP need to be listed if the particular part of the system is not a medical device?

Would the CE mark be needed since it is marketed with a medical device system?

Thanks for any insight!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
The cart might qualify as an Accessory for a Medical Device (in which case it's treated as a Medical Device).
 

Sullen-gent

Involved In Discussions
#3
I thought carts were class I accessories requiring no 510K in the US and Self declaration of conformity in the EU. That is my previous experience of them. If they have electrical connections and plug into the mains (not sure they all do this) then they would need Test house cert. for electrical safety (US).
 
Thread starter Similar threads Forum Replies Date
N German National Requirements - Safety Officer/Authorised Rep Other Medical Device Regulations World-Wide 0
Q EU Rep for Packaging waste, WEEE and Battery disposal CE Marking (Conformité Européene) / CB Scheme 0
M Authorized Rep (AR), competent authority, NCA and notified body - Differences EU Medical Device Regulations 13
Ed Panek CE REP questions about our devices ROHS compliance REACH and RoHS Conversations 1
drgnrider Job descriptions (4.4.1): Management Rep, Document Author, Document Approver Miscellaneous Environmental Standards and EMS Related Discussions 13
K What liability does the QA Manager/Management Rep hold? (US FDA environment) Career and Occupation Discussions 4
K Daily activities of a Newbie ISO Management Rep/Lead Auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
K Management Rep for CFR and ISO--global system 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Sample Questions for Auditing Management Rep , Internal Audit and Reg. Compliance Internal Auditing 7
A Do I need to send notification to Notified body and EC Rep? EU Medical Device Regulations 12
S Appointing A Quality Inspector Or Lower Position Employee As Management Rep ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Clarification on USe by date and EC Rep address on IVD INSTRUMENTS!! EU Medical Device Regulations 1
P Can a VP be the Management Rep for all 10 Divisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Definition Management Representative - Can anyone define Management Rep. Sec-5.5.2 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 15
F Management Representative - Is there a requirement for a substitute management rep? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Management Rep Responsibilities - Interpreting and Implementing ISO 9001 5.5.2c ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
A Can a organization use a disclaimer "pending AS9100 Certification" in Marketing Information? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D FDA Information - Revising the Instructions for Use US Food and Drug Administration (FDA) 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
S Mechanical Test Under FDA Freedom of Information Act Medical Device and FDA Regulations and Standards News 5
Watchcat Summary of De Novo Biocompatibility Information, 2015-2018 Other US Medical Device Regulations 0
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
W How long do you keep information about equipment no longer used? Document Control Systems, Procedures, Forms and Templates 2
L Documented Information in Internal Audits Process (9.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R What information do i need to get from the device manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
T Types of confidential information ISO 17025 related Discussions 8
D Preservation of Electronic Data / Information Technology ISO 13485:2016 - Medical Device Quality Management Systems 5
S API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
R Information on obtaining a market authorization for China China Medical Device Regulations 2
B SN95 Respirator Approval Information Other Medical Device Related Standards 0
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
K Article 18: Implant Card and information to be communicated. EU Medical Device Regulations 5
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
Richard Regalado Automotive News TISAX - VDA ISA (information security assessment) VDA Standards - Germany's Automotive Standards 5
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
Richard Regalado What could go wrong with information: Ransomware statistics and facts (2018 to present) IEC 27001 - Information Security Management Systems (ISMS) 0
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Information about Medical Device Test Laboratories Other Medical Device and Orthopedic Related Topics 4
C Missing routers/documented information Nonconformance and Corrective Action 5
MrTetris Unacceptable risk and information for safety ISO 14971 - Medical Device Risk Management 16
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4

Similar threads

Top Bottom