Measuring Function MEDDEV 2.1/5 relation with MDD 93/42/EEC

Kuldeep Singh

Involved In Discussions
#1
Hello!

We are introducing our self as Manufacture of X-Ray Medical Devices fall under Class IIb as per MDD 93/42/EEC. During our last surveillance audit , we got a Non Conformity on MDD 93/42/EEC , Annex 1 Essential Req. 10 "Device with a Measuring Function". We selected as N/A , as per our concern there is no such Measuring device in our ME Equipment's , which can help the operator to perform the procedures or anything to achieve the intended use. Although there is Dose Area Product (DAP) used in our devices to show dose delivered to patient. However it doesn't enable the x-ray, just calculate the dose delivered.

After a long discussion with auditor, he just referred us MEDDEV 2.1/5 https://ec.europa.eu/docsroom/documents/10283/attachments/1/translations/en/renditions/pdf and gave us the NC to take appropriate actions according to requirement.

Can anyone help us for our below queries?
1. After reading the MEDDEV 2.1/5 , it seems that, all the devices and examples showed in this guideline, they are just intended to use for measurements like thermometer.
2. MDD 93/42/EEC EHSR 10 i.e "Device with a measuring function" is this requirement applicable to devices intended for measurement or devices with any measuring device?
3. If there is any measuring function in our devices , like measuring scale, angular rotation, applied force etc which are not helping the operator to enable x-ray or achieving intended use. these are just use for operator guidance only. In that case our devices will become measuring device? and falls under Requirement MDD EHSR 10.

Further , Our ME Equipment are not intended for measurements however some measuring devices are used in our ME Equipment , just for ease or operator's comfort.
 
Elsmar Forum Sponsor

Jean_B

Trusted Information Resource
#2
Guidance, not a requirement. But you'll have a tough nut argueing it.

Going through it:
A is true as radiation = "- a quantity or a qualifiable characteristic of energy or of substances delivered to or removed from the human body."​
B is the stickler, as you might not 'measure' it, but have it calibrated to provide relative to some adjustable parameter and the output is a legal (SI)/acceptable unit in graduated increments. Note 2 states: "Measuring activities during the manufacturing process including those for calibration purposes are not covered by this recommendation and do not imply a measuring function of the manufactured device." Furthermore, you might be recalibrating it after the user has put it into service, which could be considered to fall under service, not manufacturing, and that drift has its own risks.​
C is true as you have implied accuracy through expectation, where non-compliance can result in significant adverse effects (under or overdosage).​
Without knowing more a definite conclusion cannot be reached, but given my expectations when you say x-ray (whether diagnostic or therapeutic), unless hard-limited to non-hazardous limits, I would tend to consider the measurement accuracy and stability concern as valid.
 
Thread starter Similar threads Forum Replies Date
C IVDD 98/79/EC Measuring Function Requirements EU Medical Device Regulations 2
N Regulatory and Safety Standards for Medical Device with Measuring Function IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
M Devices with Measuring Function - Do rulers and calipers count? EU Medical Device Regulations 7
J Subcontracting and Control Issues - Class I Medical Devices with Measuring Function ISO 13485:2016 - Medical Device Quality Management Systems 5
J Class I Medical Device with measuring function: Involvement of NB etc ISO 13485:2016 - Medical Device Quality Management Systems 9
D Accurately measuring Full Thread Length Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
R ULM Measuring Pressures General Measurement Device and Calibration Topics 1
M Missing measuring equipment General Measurement Device and Calibration Topics 6
Marco Bernardi MMC & LMC modifiers and CMM measuring techinques like diameter least squares and circularity or minimum/maximim diameter. Calibration and Metrology Software and Hardware 2
M Measuring FIM (TIR) - Two inside diameters - Conflicting readings between inspectors Manufacturing and Related Processes 1
ScottK Measuring thread flank angle on a screw Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D ASTM C1064 Temperature Measuring Device General Measurement Device and Calibration Topics 2
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V Ammeter calibration - Measuring head (on pic.) problem General Measurement Device and Calibration Topics 1
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A CE mark - Measuring Instruments Directive confusion! CE Marking (Conformité Européene) / CB Scheme 0
M Measuring Capability of Process with Multiple Specifications Capability, Accuracy and Stability - Processes, Machines, etc. 6
E ISO 13485 7.6 Control of monitoring and measuring equipment - Assess the Validity ISO 13485:2016 - Medical Device Quality Management Systems 4
D Measuring fine tubing (< 0.100") "Wall by weight" General Measurement Device and Calibration Topics 11
G Posting Measuring Equipment Accuracy for User Information General Measurement Device and Calibration Topics 4
S ISO 9001 7.1.5.2 - Actions Taken When Measuring Equipment is Found to be Unfit for Use General Measurement Device and Calibration Topics 9
G ISO 9001 and ISO 17025 - Measuring tools not in calibration system General Measurement Device and Calibration Topics 3
S Calibration - Isolated current meter - Measuring patient auxiliary leakage current Calibration and Metrology Software and Hardware 4
G Measuring customer parts on a CMM - How many decimals to report to the customer? ISO 17025 related Discussions 28
qualprod Complying with ISO 9001:2015 - 9.1.1 b - Monitoring, measuring, analyzing and evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Tagin Measuring supplier quality with small quantities Statistical Analysis Tools, Techniques and SPC 10
G Uncertainty of staging a short line scale standard on longer measuring machine? Measurement Uncertainty (MU) 4
U Measuring a Golf Club Face/Grip/Shaft Rotation General Measurement Device and Calibration Topics 7
Q Acceptable calibration accuracy of a 60" linear measuring device General Measurement Device and Calibration Topics 16
H Measuring Design Process Design and Development of Products and Processes 4
C AS9100D 7.1.5.2 / Calibration of Employee Owned Measuring Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Effectiveness Measuring and Efficiency Measuring In ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
johnny johnson New measuring equipment selection (Cg/Cgk) Capability, Accuracy and Stability - Processes, Machines, etc. 2
S Cleanrooms - Particle Measuring - ISO 14644 Other Medical Device and Orthopedic Related Topics 3
S IOQ protocol for a Micro-Vu measuring system - Is a PQ required? Qualification and Validation (including 21 CFR Part 11) 2
K ISO 13485:2016 Cl. 4.2.3 - Determine QMS Processes, Monitoring, Measuring, etc. ISO 13485:2016 - Medical Device Quality Management Systems 4
L Radius Measuring Tools General Measurement Device and Calibration Topics 4
Proud Liberal Measuring axial and radial surface finish (16 Rz) on a broached internal radius Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J IATF 16949 Cl. 7.1.5.2.1 - Gauges (Measuring Jigs) Calibration/Verification Records IATF 16949 - Automotive Quality Systems Standard 6
Claes Gefvenberg Worst measuring equipment ever? Coffee Break and Water Cooler Discussions 6
J Measuring an Untrue Radius - Metal Stamped and Formed Parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
A Calibration Interval - AS9100 - Control of Monitoring and Measuring Equipment Calibration Frequency (Interval) 8
P Tool for Measuring - Do I have to do more than one Gage R&R for the PPAP? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Auditing Fitness of Purpose for Monitoring and Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Measuring Leakage Currents with IEC 60601 defined Measurement Device (MD) IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
rob73 Advice/recommendations for equipment to measure a soft pvc tube - Optical Measuring? General Measurement Device and Calibration Topics 4
A Monitoring and Measuring Resources (7.1.5) - Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Measuring LiON Battery State of charge - Transporting batteries by Air RoHS, REACH, ELV, IMDS and Restricted Substances 1
E Not sure how to go about measuring this part Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7

Similar threads

Top Bottom