Class I Medical Device with CE Certificate - Certificate issued by a 3rd party?

S

sara_jg

#11
Hi,

we are also facing the same situation of getting a CE certificate for class I device from a third party. Even though the MDD don't require third party certification for Class I device, but we are facing demands from customers for third party CE certificate for class I device.

Request your suggestions how we can proceed further to meet the customers demand for CE certification for class I device?

can any body help with any NB who gives CE certificate for class I device?


Thanks in advance
sara
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#12
Request your suggestions how we can proceed further to meet the customers demand for CE certification for class I device?

can any body help with any NB who gives CE certificate for class I device
Such a request suggests that the customer is uninformed as to the requirements, and IMO probably is just following some internal procedure that needs a "certificate".

We've had a couple customers like this, and have sent them our declaration of conformity, with a note to the effect "here is a certificate declaring our device compliance with MDD regulations". They've both been satisfied with this.

I don't know about finding a NB that would issue a certificate for Class I, as it is outside their purview. Though it may be possible to have a 3rd party draft and issue you a certificate (just not in capacity as NB) - however, I'm pretty sure that it'd ultimately have to be signed by an authority at your end.
 
S

sara_jg

#13
Thank you Mark,

"Though it may be possible to have a 3rd party draft and issue you a certificate (just not in capacity as NB)" --- whether a product verification by a third party (like tuv or intertek) and their certification along with our declaration of conformity will be more appropriate to serve this purpose?

Thank you in advance
sara
 

Mark Meer

Trusted Information Resource
#14
...whether a product verification by a third party (like tuv or intertek) and their certification along with our declaration of conformity will be more appropriate to serve this purpose?
The 3rd party testing is only tangentially related to CE (in that it is a convenient option for having evidence of conformity to the MDD essential requirements). However, the "certification" from a 3rd party (e.g. applying their NRTL mark) is not necessary for CE purposes.

Ultimately, this is a customer-supplier relationship issue, so there are no rules. It is up to you and the customer to sort out what is needed to proceed with your relationship.

I wouldn't go into the weeds with 3rd party test reports/certification (unless, of course, they specifically request it). In my experience, when it comes to customers, complicating things with explanations of "harmonized standards", "presumption of conformity", "3rd party certification to (whatever standard)"... is not all that productive. It will often appear that you are trying to make excuses for what you don't have.

If they are requesting something that is not possible to provide (which they are), I suggest be upfront and provide a simple alternative:
1. Clarify that Class I devices are not subject to NB CE certification.
2. Offer instead to give them your Declaration of Conformity for their records, as a "certificate" (albeit self-declared) of CE conformity.

Best of luck!
MM.
 
#15
Hi Sara,
While it is correct, as mentioned in the previous posts, that most class I devices do not require a certificate from a Notified Body, we are often requested to provide this service to satisfy client demands. Please feel free to PM me if you'd like more information.
cheers,
David
 

Ronen E

Problem Solver
Staff member
Moderator
#16
Hi Sara,
While it is correct, as mentioned in the previous posts, that most class I devices do not require a certificate from a Notified Body, we are often requested to provide this service to satisfy client demands. Please feel free to PM me if you'd like more information.
cheers,
David
David,

First, thanks for joining the “answering team”.
Second (and I’m writing under a Cove Moderator’s hat now), If you are in some way representing a NB (or another type of CB) it would be appropriate to disclose it.

Thanks again,
Ronen.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#17
<snip> First, thanks for joining the “answering team”. </snip>
Ditto from me. And - If you are in some way representing a NB (or another type of CB), it's OK. You might want to put details in your "User Profile". We welcome active participants!
 
Thread starter Similar threads Forum Replies Date
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 4
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S How to register class IIA medical device accessories EU Medical Device Regulations 1
U Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden Other Medical Device and Orthopedic Related Topics 2
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
R Countries that accept 510k approvals - Class II nonsterile medical device Other Medical Device Regulations World-Wide 2
B Class III Medical Device Accelerated conditions Other Medical Device Related Standards 1
D FDA Approved Class II Medical Device? Other US Medical Device Regulations 11
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
D Class II medical device - When should a complaint be closed? Customer Complaints 6
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
A Does Class 1 Medical Device need to be certified to MDSAP? Canada Medical Device Regulations 5
N Can we take a part from 510k cleared medical device and use it in class I device? Other US Medical Device Regulations 3
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Selling a class II Medical Device in Canada in Pharmacies Elsmar Xenforo Forum Software Instructions and Help 10
S Acrylic in Class II b Active Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
S Conformity Assessment Route question for Class IIa medical device under MDR EU Medical Device Regulations 3
K Inventory Control - Class II (IIb for CE) medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
S Software Release Note - Class A stand alone software medical device IEC 62304 - Medical Device Software Life Cycle Processes 2
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M How is Class I Medical Device Compliance Enforced? EU Medical Device Regulations 7
K Calibration of Dose Area Product (DAP) Meter in our Class IIb X-Ray Medical Device General Measurement Device and Calibration Topics 1
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Per the FDA regulations can a medical device be class I despite that it is sterile? Other Medical Device Related Standards 4
M Include IFU in Class II Medical Device Marketing Brochure? US Food and Drug Administration (FDA) 2
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom