Nanomaterials used as coating on class I MD - rule 19

RA_QA_Expert

Involved In Discussions
#1
Hi,

if general class I medical device (e.g. wheelchair, hospital bed, crutch,...) is coated by nanomaterial do I need to use classification MDR rule 19 and re-classify the device? That means, if I cover e.g.handle of a crutch by nano-layer, is it automatically higher class than class I?

Intended use of the coated device is still the same, but surface can have e.g. antimicrobial properties. It is very often used now, and not only in healthcare sector.

Thanks for sharing of your opinions/experience.
 
Elsmar Forum Sponsor

dgrainger

Trusted Information Resource
#2
I would think so - rule 19 appears to cover all use of nanomaterials in/on a device. You just need to work out the "potential for internal exposure".
 

chris1price

Trusted Information Resource
#3
I am not sure of the materials you are using, I would suggest confirming they meet the MDR definition of a nano-material in Article 2(18-21) and Commission Recommendation 2011/696/EU.
 

rob73

looking for answers
#4
Hi,

if general class I medical device (e.g. wheelchair, hospital bed, crutch,...) is coated by nanomaterial do I need to use classification MDR rule 19 and re-classify the device? That means, if I cover e.g.handle of a crutch by nano-layer, is it automatically higher class than class I?

Intended use of the coated device is still the same, but surface can have e.g. antimicrobial properties. It is very often used now, and not only in healthcare sector.

Thanks for sharing of your opinions/experience.
Have you checked with the manufacturer of the coating that it is definitely using nano-materials? Ours specifically state that nano-materials (in this case silver) are not used. If it is a nano material then i would be looking to my NB for guidance on what the lowest class I can get away with, or looking for an alternative that is not nano-material based. Jumping from class 1 to class 3 is not something I would like to have to do.
 

SKM.Sunil

Involved In Discussions
#5
Hi,

if general class I medical device (e.g. wheelchair, hospital bed, crutch,...) is coated by nanomaterial do I need to use classification MDR rule 19 and re-classify the device? That means, if I cover e.g.handle of a crutch by nano-layer, is it automatically higher class than class I?

Intended use of the coated device is still the same, but surface can have e.g. antimicrobial properties. It is very often used now, and not only in healthcare sector.

Thanks for sharing of your opinions/experience.


No the classification shall not change, your device are not expose to internal environment. The classification shall remain same, :agree1:
unless; somehow you try to classify higher :bonk:
 
Thread starter Similar threads Forum Replies Date
T Information regarding Nanomaterials in Medical Devices EU Medical Device Regulations 6
M Nanomaterials? Products based on human cell or tissue derivatives? EU Medical Device Regulations 7
P Can credentials (ID/PW) used to login be the same as when applying Electronic Signature (Part 11) US Food and Drug Administration (FDA) 2
D Recommendations for equipment used to validate cold storage units General Measurement Device and Calibration Topics 3
E Compressed air quality in ME equipment (used in OR) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
C Items used for Design Verification Design and Development of Products and Processes 7
R Validation of Software used in Verification Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
A UDI-PI for IVDs used in house EU Medical Device Regulations 5
L A certificate of conformance used to support a calibration General Measurement Device and Calibration Topics 6
D Tracking software versions used with instruments ISO 13485:2016 - Medical Device Quality Management Systems 0
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
M Methods used to label the package EU Medical Device Regulations 4
P Cleaning Agents to be Used on Metals & Plastics Qualification and Validation (including 21 CFR Part 11) 1
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 2
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
R Tools used for measuring (New to metrology) General Measurement Device and Calibration Topics 9
L Requirements for Cables used for Low-Voltage DC Mains (12-36VDC) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N Voltage Doubler fail - can gas tubes be used? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
N Maximum mains voltage used when applying 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
W How long do you keep information about equipment no longer used? Document Control Systems, Procedures, Forms and Templates 2
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
Q PPT used as Design Review ISO 13485:2016 - Medical Device Quality Management Systems 3
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
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
D Can PFMEA be used in disposition of NC material? ISO 14971 - Medical Device Risk Management 4
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
John Broomfield Informational Terms used in quality management [Deleted] Misc. Quality Assurance and Business Systems Related Topics 6
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
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
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
R Foam mattresses used in hospitals - compliance with MDR requirements? EU Medical Device Regulations 6
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
R PMCF - centers/countries used CE Marking (Conformité Européene) / CB Scheme 0
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
G Can calibrated device values be used instead of manufacturers spec? General Measurement Device and Calibration Topics 2
M Informational US FDA – URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Dev Medical Device and FDA Regulations and Standards News 0
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
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 6
I Recommendation about h and k values when CUSUM charts are used Statistical Analysis Tools, Techniques and SPC 4
R Please share your method used for PEMS Validation IEC 62304 - Medical Device Software Life Cycle Processes 5

Similar threads

Top Bottom