SBS - The Best Value in QMS software

Partial Compliance to an ISO Standard for Medical Device CE Marking

M

Mike Blanc

#1
Dear All,

My company is making a new device and we had used an ISO standard as product standard. This device has certain new and improve features, as a result we are unable to meet only one of the ISO standard requirement.

My QA colleague mentioned in order to get CE mark for this device (class IIa), we will need to comply 100% to the ISO standard.

My questions are:
1. Do I need to comply 100% to the standard in order to claim compliance?

2. If I do not claim compliance to the standard, will I still able to get the CE mark?

3. Can I claim partial compliance to the standard? E.g Comply to ISO XYZ, exclude clause 1.2.3.

4. By claiming partial compliance, will it affect the application for CE mark (device is class IIa)?

Looking forward to your advise.:thanx:
 
Elsmar Forum Sponsor
M

Mike Blanc

#3
Re: Partial compliance to an ISO standard for CE marking

Hi Joanne,

No, it is a non-active medical device ISO standard.

Will you be able to provide any guidance document or regulation? My QA colleague is a tough nut to crack.
 
#4
Re: Partial compliance to an ISO standard for CE marking

Mike - you can apply any standard you choose in part.
You can claim compliance to a standard with justifications for any exclusions.
This will not affect your CE Marking.
 

somashekar

Staff member
Super Moderator
#6
Re: Partial compliance to an ISO standard for CE marking

How you meet the essential requirement is of importance...
Justify same (harmonized standards first + other standards if not within the harmonized)
Provide evidence
.
..
...
Discuss threadbare with your NB
 

yodon

Staff member
Super Moderator
#8
Maybe it depends on the circumstances but, for example, we do products frequently that must comply with 60601-1 but don't have, say, pressure vessels. When preparing for the testing, we just claim those as N/A. The test report shows what was tested / what was N/A.
 

Oz32

Registered
#9
Maybe it depends on the circumstances but, for example, we do products frequently that must comply with 60601-1 but don't have, say, pressure vessels. When preparing for the testing, we just claim those as N/A. The test report shows what was tested / what was N/A.
Thank you. And on an ERC for example, do you list full compliance since you fully comply to anything applicable?
 

robert.beck

Involved In Discussions
#10
only list what you comply with. if compliance is limited there should be a justification, in the test report, or in the technical file. the justification would most likely be risk-based if in the technical file, or N/A if in the test report. some test houses use N/E for "not examined' and issue a test report that mentions the parts of the standard that were not examined. These types of incomplete test reports are sometimes mistakenly used as indicating compliance by naive users. in my experience with big-name test houses that use N/E, it's often because they did not understand the device.

I agree with Yodon about 60601-1. that is a long extensive standard that covers a lot of ground; much of it does not apply to many devices. for those situations, it's perfectly legitimate to indicate that the essential requirements of 60601-1 are met.
 
Thread starter Similar threads Forum Replies Date
A Classification of Medical Device with Partial Compliance with a particular standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
NDesouza Is my Partial FAI an Assembly or Detail? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Full or Partial FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
B Temperature loop: partial calibration General Measurement Device and Calibration Topics 10
S CTS/CSE Waveforms Testing - Partial Recognition of IEC 60601-2-25 Standard by FDA IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B AS9102 - Completing Partial FAI's for Baseline Part Numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P AS9102 full FAl or a partial FAI after production inactivity period AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Non ASTM Partial Immersion LGT emergent stem correction General Measurement Device and Calibration Topics 3
C Partial Design Validation and changes to a critical supplier 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Use of Harmonised Standards (Full or Partial) ISO 13485:2016 - Medical Device Quality Management Systems 1
M Partial Implementation of ISO 9001 in a Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
T Is a Removable Partial Denture classified as Class I Medical Device? EU Medical Device Regulations 6
M "Partial Design" Designation and Applicable ISO 9001:2015 Exemptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S When to switch from a Partial AS9102 back to a Full AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
K Partial FAI on Semi-Complete Parts question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
N Can we do a Partial Gamma Validation on a Similar Product (Syringes) ISO 13485:2016 - Medical Device Quality Management Systems 6
M Partial Incoming (Receiving) Inspection Delivery Inspection. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
D Delta or Partial FAI (First Article Inspection) - What are the differences? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Partial FAI form requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Partial ISO TS 16949 Certification IATF 16949 - Automotive Quality Systems Standard 14
P Part 11 Hybrid System - Partial paper based record but with e-signature Qualification and Validation (including 21 CFR Part 11) 4
J AS9102 FAI (First Article Inspection) Full or Partial - Changes to NC programming Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Error Accumulation - Combined Result without going to Partial Derivitaves Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Partial Joint (Hip Prosthesis) Replacement Class inquiry EU Medical Device Regulations 3
T Partial Shipping of Lots - Shipping of product prior to the lot being completed ISO 13485:2016 - Medical Device Quality Management Systems 4
I Partial Least Square Regression Result - Question Using Minitab Software 3
E Interpreting Partial Least Square Results Using Minitab Software 1
B Not Full (Partial) Lot at End of the Shift - Sample Size AQL - Acceptable Quality Level 4
S "Partial Buyout" Considerations for TS system - HELP IATF 16949 - Automotive Quality Systems Standard 13
K ROHs compliance requirement REACH and RoHS Conversations 1
Z Choice of PTC heater voltage to maximize user safety and ease of CE compliance to LVD CE Marking (Conformité Européene) / CB Scheme 0
Z REACH compliance for low volume product REACH and RoHS Conversations 1
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 4
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
H Automotive wires - Compliance with USCAR21-4 & USCAR38-1 Various Other Specifications, Standards, and related Requirements 0
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 2
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
D HIPAA, HITECH and Interoperability compliance route Medical Device and FDA Regulations and Standards News 2
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3

Similar threads

Top Bottom