Essential Principle Checklist for Medical Device Conformity Assessment Other than IVD Medical

Device
Medical Device Serial Number/Identity:
Medical Device Name:
Essential Principle Applicable to Method Used to Method Reference to
theDevice? Demonstrate Reference Supporting Controlled
Conformity Documents
General Requirements

1. Medical devices should be designed and

manufactured in such a way that, when used underthe conditions and for the purposes intended
and,where applicable, by virtue of the technicalknowledge, experience, education or training
FMEA Risk Management File
ofintended users, they will notcompromise the clinicalcondition or the safety of patients, or the
A FTA Clinical Test Report
safety andhealth of users or, where applicable, other persons,provided that any risks which may
Clinical Evaluation Instruction for Use
be associated with their use constitute acceptable risks when weighed
against the benefits to the patient and arecompatiblewith a high level of protection of health and
safety.
2. The solutions adopted by the manufacturer forthe design and manufacture of the devices A FMEA Risk Management File
shouldconform to safety principles, taking account ofthe generally acknowledged state of the FTA Clinical Test Report
[Link] risk reduction is required, themanufacturer should control the risk(s) so thatthe Clinical Evaluation Instruction for Use
residual risk(s) associated with each hazard isjudged acceptable. The manufacturer shouldapply
the following principles in the priorityorder listed:
identify known or foreseeable hazards andestimate the associated risks arising from
theintended use and foreseeable misuse,
eliminate risks as far as reasonablypracticable through inherently safe designand
manufacture,
reduce as far as is reasonably practicable theremaining risks by taking adequateprotection
measures, including alarms,
inform users of any residual risks.
Essential Principle

3. Devices should achieve the performanceintended by the manufacturer and be

designed,manufactured and packaged in such a way thatthey are suitable for one or more of Instruction for Use
A Stability Test method
thefunctionswithin the scope of the definition of a medicaldevice applicable in each jurisdiction. Stability test report

4. The characteristics and performances referred toin Clauses 1, 2 and 3 should not be
adverselyaffected to such a degree that the health orsafetyof the patient or the user and, where
applicable,of other persons are compromised during thelifetime of the device, as indicated by FMEA Risk Management File
themanufacturer, when the device is subjected to thestresses which can occur during A FTA Clinical Test Report
normalconditions of use and has been properlymaintained in accordance with themanufacturer‘s Clinical Evaluation Instruction for Use
instructions.

5. The devices should be designed,manufacturedand packed in such a way that

theircharacteristics and performances during theirintended use will not be adversely affected
Stability Test method Instruction for Use
undertransport and storage conditions (for example,fluctuations of temperature and humidity) A
Packaging Instructions Stability test report
takingaccount of the instructions and informationprovided by the manufacturer.

6. The benefits must be determined to outweigh anyundesirable side effects for FMEA Risk Management File
theperformancesintended. A FTA Clinical Test Report
Clinical Evaluation Instruction for Use
Design and Manufacturing Requirements
Essential Principle

7. Chemical, physical and biological properties

The devices should be designed andmanufactured insuch a way as to ensure the characteristics
andperformance referred to in Clauses 1 to 6 of theGeneral Requirements'. Particular attention Material Safety Data
FMEA
should bepaid to: Sheet
FTA
the choice of materials used, particularly asregards toxicity and, where
Corrosion, Chemical Material Test Report
appropriate,flammability,
Resistance & Hardness Risk Management File
the compatibility between the materials used andbiological tissues, cells, body fluids,
Test
andspecimens, taking account of the intendedpurpose of the device,
the choice of materials used should reflect,whereappropriate, matters such as hardness, wear
andfatigue strength.
The devices should be designed, manufactured andpacked in such a way as to minimize the risk
FMEA
posedby contaminants and residues to the persons involvedin the transport, storage and use of Risk Management File
FTA
the devices and topatients, taking account of the intended purpose ofthe product. Particular
attention should be paid totissues exposed and to the duration and frequency ofexposure.
8.------------------------------etc.-------------------------------------------------------------------------------
9.-----------------------------etc.-------------------------------------------------------------------------------
I declare that the information provided in this EP format is accurate and correct and the device conforms to all
Applicable requirements stipulated in this Guideline and other international standards.
Name: ___Stephen Yun________________________________________________
Signature: ____________________________________________________
Position: __________________________________________________
Date: November,,2019