CE Marking for vibrator personal pleasure toy

#1
Hello,

It is my first thread in here. I was asked by an aspiring client to prepare documentation for CE marking of a vibrator pleasure toy, vibrator class 2 non implantable device. It has low risk battery.

I haven't been able to locate the corresponding directive and have no previous experience in products of this type so can someone help me with the required documentation? Google research didn't yield any fruitful results.

My experience so far has been for certifying class IIb implantable devices according to 93 42EC with full technical file preparation, risk management and bibliographical research.

Thank you very much!
 
Elsmar Forum Sponsor

fialor

Involved In Discussions
#2
Jimmis, it is best to start off with the indication/intended use of the device, determine whether it falls within the definition of the current applicable MDD 93/42/EEC or MDR (2017-745 applicable from May 2020). If it is confirmed by your indication as a medical device, then use the classification rules to define the class.
I hope that helps.
 
#7
Hello and thank you for the replies, the customer has decided that his product is a class IIa according to 93/42EC. I presume the Technical file is almost identical to that of a class IIb product according to the same med dev?
 

chris1price

Trusted Information Resource
#8
Yes, the Technical File would be very similar. I assume you are still looking at the MDD, in which case Annex V may be appropriate for as a conformity assessment route. Going forward, the technical File requirements for the MDR will be more onerous.

For those wondering, such products can be indicated for therapeutic purposes, and so are medical devices.
 

Rincewind

Involved In Discussions
#9
Hello and thank you for the replies, the customer has decided that his product is a class IIa according to 93/42EC. I presume the Technical file is almost identical to that of a class IIb product according to the same med dev?
Does the intended use of the product support this? I struggle to see this if they say it is for personal pleasure.
 
Thread starter Similar threads Forum Replies Date
M CE marking for NON-EU EU Medical Device Regulations 0
NDesouza Getting Rid of Part Marking Errors Benchmarking 39
S CE marking for a product upgrade CE Marking (Conformité Européene) / CB Scheme 0
P CE Marking UK Membership CE Marking (Conformité Européene) / CB Scheme 1
J Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals CE Marking (Conformité Européene) / CB Scheme 4
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
N CE marking colour for Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
A EAC Marking in Medical Device Other Medical Device Regulations World-Wide 0
B Marking of Medical Electrical equipment and accessories - Cl. 7.2.2 "Identification" and Cl. 7.2.4 "Accessories" IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Clinical investigations of medical devices - not for CE marking EU Medical Device Regulations 0
P Marking Machinery for Israel CE Marking (Conformité Européene) / CB Scheme 3
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
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
Ed Panek Is Shelf Life Change a significant change? CE Marking CE Marking (Conformité Européene) / CB Scheme 7
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 7
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
CPhelan Do you require MDSAP for CE Marking of a Medical Device or is ISO13485:2016 with clinical data sufficient? CE Marking (Conformité Européene) / CB Scheme 5
P CE Marking EN ISO 13849-1: Electrical Panel behind interlocked doors CE Marking (Conformité Européene) / CB Scheme 9
M Cleaning Process after laser marking on orthopaedic implants Other Medical Device and Orthopedic Related Topics 3
H Safety and efficacy study for CE marking CE Marking (Conformité Européene) / CB Scheme 1
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
K Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products CE Marking (Conformité Européene) / CB Scheme 1
JoshuaFroud CE Marking and Brexit - Product shipped to a distributor prior to the March deadline EU Medical Device Regulations 2
M Informational Design for new product safety marking for the no-deal Brexit scenario Medical Device and FDA Regulations and Standards News 1
E Safety work instruction if the equipment have the CE Marking and a Manual with safety instruction Various Other Specifications, Standards, and related Requirements 16
Z Direct Part Marking (DPM) requirements for Class II Medical Devices Manufacturing and Related Processes 0
M Medical Device News FDA Guidance - UDI: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking Other US Medical Device Regulations 0
J Virtual Manufacturer and CE Marking EU Medical Device Regulations 7
N CE marking for distributed product CE Marking (Conformité Européene) / CB Scheme 1
S CE Marking requirements - A Medical device with different config sold under same name EU Medical Device Regulations 0
J Class 1 CE Marking - Can this be removed from the label on the product? CE Marking (Conformité Européene) / CB Scheme 4
I Tool Control Marking Voiding Warranty AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
C Data Matrix and DPM (direct part marking) UDI Standards - ISO/IEC TR 29158 Other US Medical Device Regulations 2
K UDI Direct Marking Compliance Date Clarification and one other UDI question Other US Medical Device Regulations 0
T CE Marking & Compliance to MDD, EMC, RoHS, and GPSD REACH and RoHS Conversations 4
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N How to obtain Own Brand Label (OBL) CE Marking? EU Medical Device Regulations 18
Q Does CE Marking include compliance to WEEE and packaging waste? CE Marking (Conformité Européene) / CB Scheme 4
C Looking for Testing Laboratory for Aluminum Products - CE Marking General Measurement Device and Calibration Topics 5
J CE Marking Requirements and IEC 60617 - Electrical Schematics Symbols CE Marking (Conformité Européene) / CB Scheme 1
H CE Marking on Multiple-Components Medical Products EU Medical Device Regulations 8
U CE Marking of Customized Ruggedised Computer Systems Solutions CE Marking (Conformité Européene) / CB Scheme 5
L IEC/EN 60601-1 Certificate required before CE Marking? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Canada Electrical Equipment Marking Language Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q Labeling/Marking Location for BF Symbol IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Single Use Disposable Dental Syringe - CE Marking Advice EU Medical Device Regulations 4
M Natural Rubber / Latex Product CE Marking - Requirements EU Medical Device Regulations 3
V 510(k) vs. CE Marking Summative Usability Testing Expectations IEC 62366 - Medical Device Usability Engineering 4
Similar threads


















































Top Bottom