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MINISTRY OF
HEALTH
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THE SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 2426/QD-BYT
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Hanoi, May 15,
2021
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DECISION
ON
PROMULGATION OF GUIDANCE ON THE PREPARATION OF ASEAN COMMON SUBMISSION DOSSIER
FOR MEDICAL DEVICES
MINISTER OF HEALTH
Pursuant to the Government’s Decree No.
75/2017/ND-CP dated June 20, 2017 defining the functions, tasks, entitlements
and organizational structure of the Ministry of Health;
Pursuant to the Government’s Decree No.
36/2016/ND-CP dated May 15, 2016 on management of medical devices;
Pursuant to the Government’s Decree No.
169/2018/ND-CP dated December 31, 2018 on amendments to the Government’s Decree
No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices;
Pursuant to the Government’s Decree No.
03/2020/ND-CP dated January 1, 2020 on amendments to the Government’s Decree
No. 36/2016/ND-CP dated May 15, 2016 on management of medical devices, amended
by the Government’s Decree No. 169/2018/ND-CP dated December 31, 2018;
At the request of Director of Department of
Medical Devices and Works.
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Article 1. Scope
Issue together with this Decision the ASEAN Common
Submission Dossier Template (CSDT) for medical devices, applied to applications
for registration of medical devices of class B, C, D.
Article 2. Entry in force
This Decision comes into force as of its date of
promulgation.
Article 3. Implementation
The Chief of the Ministry Office, the Ministerial Chief
Inspector, Directors, General Directors affiliated to the Ministry of Health,
Directors of the Departments of Health of provinces or central-affiliated
cities and relevant entities shall implement this Decision.
Difficulties that arise during the implementation
of this Circular should be reported to the Ministry of Health for
consideration./.
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ASEAN
COMMON SUBMISSION DOSSIER TEMPLATE FOR MEDICAL DEVICES
(Issued together
with Decision No. 2426/QD-BYT dated May 15, 2021 of the Ministry of Health)
ASEAN COMMON
SUBMISSION DOSSIER FOR MEDICAL DEVICES
Name of registrant of medical devices (name,
address)
The registrant declares that all the information
given above is true and correct to the best of our knowledge and belief; if
not, we are aware that we may be held liable for it.
1. Executive summary
1.1. Overview about the medical device
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1.2. Commercial marketing history
A list of countries where the medical device is
currently marketed is to be provided. The date and country of first
introduction globally is also to be provided.
1.3. Intended uses and indications for use
Intended purposes and indications for use of the
medical device in labeling or manual.
1.4. Registration status in countries
Registration status in countries: EU
member states, Japan, Canada, Australia (TGA), USA (FDA), England, Switzerland,
including registration status (i.e. approval, pending approval, rejected,
non-registered, etc.), intended use and indications for use, first registration
date1.
This information is to be provided in a tabular
format as given below:
No.
Country or
Reference agency
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Registration
status
Date
1
2
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3
copies (or links) of certificates or approval
letters from each reference agency (if any).
1.5. Important safety/performance related
information
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The summary of reported adverse events at least
contains description of the adverse events, number and frequency of occurrence
of adverse events (number of reports/total units sold). This is to be provided
in a tabular format as given below:
No.
Description of
adverse event
Number or
frequency of occurrence
1
2
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3
For reported field safety corrective actions (FSCAs),
at least containing: date of FSCA, summary of event, names of countries or
territories where FSCA was conducted. This is to be provided in a tabular
format as given below:
No.
Date
Summary of event
Name of
country/territory
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3
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If there have been no adverse events or FSCAs since
first introduction on the global market or within the last 5 years, an
attestation from the product owner that this is the case, is required.
If the medical device contains one or more of the
following, a description of the following must be provided:
● animal or human cells, tissues and/or derivatives
thereof, rendered non-viable (e.g. porcine heart valves, catgut sutures, etc);
● cells, tissues and/or derivatives of microbial or
recombinant origin (e.g. dermal fillers based on hyaluronic acid derived from
bacterial fermentation processes)
● irradiating components, ionising (e.g. x-ray) or
non-ionising (e.g. lasers, ultrasound, etc).
2. Essential Principles
Conformity Checklist (in Vietnamese or in English)
Provide the Essential Principles Conformity
Checklist demonstrating the safety and efficacy of the medical devices issued
by the owner as described in the Annex hereto appended to demonstrate
conformity to the Essential Principles.
If the medical device is registered in EU member
states, a Essential Principles Conformity Checklist under EU legislation may be
provided.
3. Medical device description
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A detailed description of the medical device
attributes is necessary to explain how the medical device function, the basic
scientific concepts that form the fundamentals for the medical device. Describe
the component materials and accessories used in its principles of operation as
well as packaging. A complete description of each functional component,
material or ingredient of the medical device should be provided, with labeled
pictorial representation of the medical device in the form of diagrams,
photographs or drawings, as appropriate.
3.2. Intended purpose
This means the use for which the medical device is
intended, for which it is suited according to the data supplied by the product
owner in the instructions as well as the functional capability of the medical
device.
3.3. Indications
This is a general description of the disease or
condition that the medical device will diagnose, treat, prevent, cure or
mitigate and includes a description of the target patient population for which
the medical device is intended.
3.4. Instructions for use
These are all necessary information from the
product owner including the procedures, methods, frequency, duration, quantity
and preparation to be followed for safe use of the medical device.
3.5. Contraindications
Conditions under which the medical device should
not be used for the safety of the patient, e.g. disease history, physiology
characteristics of the patient, etc. on the labeling or manual of the medical
device.
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3.6. Warnings
This is the specific hazard alert information that
a user needs to know before using the medical device.
3.7. Precautions
This alerts the user to exercise special care
necessary for the safe and effective use of the medical device. They may include
actions to be taken to avoid effects on patients/users that may not be
potentially life-threatening or result in serious injury, but about which the
User should be aware. Precautions may also alert the user to adverse effects on
the medical device of use or misuse and the care necessary to avoid such
effects.
3.8. Potential adverse effects
These are potential undesirable and serious
outcomes (death, injury, or serious adverse events) to the patient/user, or
side effects from the use of the medical device, under normal conditions.
3.9. Alternative therapy
This is a description of any alternative practices
or procedures for diagnosing, treating, curing or mitigating the disease or
condition for which the medical device is intended.
3.10. Materials (in Vietnamese or in
English)
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For medical devices other than IVD medical device:
- List of materials of the medical device making
either direct (e.g. with the mucous membrane) or indirect contact (e.g. during
extracorporeal circulation of body fluids) with a human body, and chemical,
biological and physical characterization of the materials of the device.
- For medical devices intended to emit ionising
radiation, information on radiation source (e.g. radioisotopes) and the
material used for shielding of unintended, stray or scattered radiation from
patients, users shall be provided.
- Where there are specific concerns related to the
safety of materials used in the medical device e.g. impurities, residue levels
and exposure to plasticizers such as Bis(2-ethylhexyl) phthalate (DEHP),
additional information to address these safety concerns shall be provided. This
could include conformity to relevant material standards, Certificate of
Analysis, or a risk assessment on the safety of the materials used. Depending
on the risk of the exposure of these materials to the patient and/or user,
additional mitigation measures such as informing users of the presence of these
materials via the device labelling, may be required.
For IVD reagents, calibrators, controls:
- A list of all materials used to manufacture the
product shall be provided, including: name of material, role in the finished
product.
- All components, biological characteristics and
source of the materials used in the reactions for testing shall be
characterised: including antibodies, antigens, enzymes, conjugates, PCR
primers, probes, calibrators, controls, etc.
- If the medical device contains controlled
substances (drugs or irradiating components, nonionising or ionising),
information on their ingredients, content, roles, e.g. Buprenorphine in drug
assay kit, odide-131 in the Radioimmunoassay kit, radio-labeled Phosphorus-32
DNA probes in Southern blots, etc. must be provided.
- For IVD medical devices of class C, D:
information on standards or testing of materials used in reaction (except
stabilizer) shall be provided. Information is presented for each active
ingredient (antigen, antibody, conjugate, etc.).
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The functional characteristics and technical
performance specifications for the medical device including, as relevant,
accuracy, sensitivity, specificity of measuring and diagnostic medical devices,
reliability and other factors; and other specifications including chemical,
physical, electrical, mechanical, biological, software, sterility, stability,
storage and transport, and packaging to the extent necessary to demonstrate
conformity with the relevant Essential Principles.
3.12. Other Descriptive Information
Other important descriptive characteristics not
detailed above, to the extent necessary to demonstrate conformity with the
relevant Essential Principles (for example, the biocompatibility category for
the finished medical device, etc.).
Note: The above information will
typically be contained in already existing instructions for use.
4. Summary of Design
Verification and Validation Documents (in Vietnamese or in
English)
This section should summarise or reference or
contain design verification and design validation data to the extent
appropriate to the complexity and risk class of the medical device.
Such documentation should typically include:
● declarations/certificates of conformity to the
“recognized” standards listed as applied by the product owner; and/or
● summaries or reports of tests and evaluations
based on other standards, manufacturer methods and tests, or alternative ways
of demonstrating compliance.
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The data summaries or tests reports and evaluations
would typically cover, as appropriate to the complexity and risk class of the
medical device:
- a listing of and conclusions drawn from published
reports that concern the safety and performance of aspects of the medical
device with reference to the Essential Principles;
- engineering tests;
- laboratory tests;
- biocompatibility tests;
- animal tests;
- simulated use;
- software validation.
4.1. Pre-clinical Studies
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Complete pre-clinical physical test data must be
provided, as appropriate. The report must include the objectives, methodology,
results and product owner’s conclusions of all physical studies of the medical
device and its components. Physical testing must be conducted to predict the
adequacy of medical device response to physiological stresses, undesirable
conditions and forces, long-term use and all known and possible failure modes.
Pre-clinical animal studies used to support the
probability of effectiveness in humans must be reported. These studies must be
undertaken using good laboratory practices. The objectives, methodology,
results, analysis and product owner’s conclusions must be presented. The study
conclusion should address the medical device’s interactions with animal fluids
and tissues and the functional effectiveness of the medical device in the
experimental animal model(s). The rationale (and limitations) of selecting the
particular animal model should be discussed.
Proof of electrical safety and electromagnetic
compatibility must be provided. For example, if the owner claims that the
product meets the requirements of IEC 60601-1 and IEC 60601-1-2, a summary test
report and/or certificate of conformity must be provided to demonstrate that
the equipment meets these standards.
For medical devices provided sterile, sterilization
validation reports shall be provided. if the sterilant is toxic or produces
toxic residuals (e.g. ethylene oxide residues), test data and methods that
demonstrate that post-process sterilant and/or residuals are within acceptable
limits must be presented.
For connected medical devices (e.g. wireless
enabled, internet-connected and network-connected devices), information to
support the cybersecurity of these devices shall be provided. This will
include, but is not limited to: Cybersecurity vulnerabilities and risk management
approach for the device, cybersecurity controls measures, on-going plans for
surveillance, timely detection and management of the cybersecurity related
threats during the useful life of the device. A declaration of manufacturer or
product owner for wireless enabled, internet-connected and network-connected
devices to ensure cyber security.
4.1.1. Software Verification and Validation
Studies (if applicable)
The correctness of a software product is another
critical product characteristic that cannot be fully verifies in a finished
product. The product owner must provide evidence that validates the software
design and development process. This information should include the results of
all verification, validation and testing performed in-house and in a user’s
environment prior to final release, for all of the different hardware
configurations identified in the labelling, as well as representative data
generated from both testing environments.
4.1.2. Medical Devices Containing Biological
Material
Results of studies substantiating the adequacy of
the measures taken with regards to the risks associated with transmissible
agents must be provided. This will include viral clearance results for known
hazards. Donor screening concerns must be fully addressed and methods of
harvesting must also be fully described. Process validation results are
required to substantiate that manufacturing procedures are in place to minimise
biological risks.
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4.2.1. Analytical performance
Studies to determine analytical performance of the
medical device shall be provided, including: analytical sensitivity, analytical
specificity, limit of detection (LOD), limit of quantitation (LOQ), linearity,
range, accuracy, repeatability, interfering substances, robustness, etc.
Performance criteria will depend on each medical device.
Information on samples used for evaluation
(negative controls, positive controls, baseline standards, calibrator panels,
reagents, ...).
Study reports should include objectives, methods,
results, and conclusions of the study. The results and conclusions should
clearly demonstrate that the product has the characteristics suitable for its
intended use.
4.2.2. Stability
Provides stability study reports, including
real-time stability and accelerated aging stability (where applicable). In the
case of not doing a real-time stability study but only under accelerated aging
conditions, a full and reasonable explanation should be given.
In-use stability study reports for products that
are used repeatedly after opening shall be provided.
Transport stability studies, performed under real
or simulated conditions shall be provided.
Stability study reports should include objectives,
methods, results, and conclusions of the study.
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A clinical evaluation report of medical device
should be provided. Where applicable, this evaluation may take the form of a
systematic review of existing bibliography, clinical experience with the same
or similar medical devices, or by clinical investigation. Clinical
investigation is most likely to be needed for higher risk class medical
devices, or for medical devices where there is little or no clinical
experience.
The clinical evaluation report should include the
purpose and context of the clinical evaluation, clinical data input, evaluation
and data analysis, and conclusions about the safety and efficacy of the medical
device.
The clinical evaluation report should contain all
the necessary information as an independent document for review by regulatory
authorities. The clinical evaluation report should summarize:
- The technology that the medical device uses, the
indications for use, the safety and clinical efficacy claims, if any.
- The nature and scope and scale of the clinical
data to be evaluated.
- Clinical data, recognized standards that
demonstrate the safety and effectiveness of medical device.
4.3.1. Use of Existing Bibliography
Copies are required of all literature studies, or
existing bibliography, that the product owner is using to support safety and
effectiveness.
Clinical evidence of effectiveness may comprise
medical device-related investigations conducted in Vietnam or other countries.
It may be derived from relevant publications in a peer-reviewed scientific
literature. The documented evidence submitted should include the objectives,
methodology and results presented in context, clearly and meaningfully. The
conclusions on the outcome of the clinical studies should be preceded by a
discussion in context with the published literature.
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Clinical experience is clinical data obtained from
clinical use of the product, not clinical investigation. Clinical experience
can be with the product itself or with a similar product.
Clinical experience can be obtained from the
following data:
- Post-marketing surveillance reports from product
owners, regulatory authorities, cohort studies (may contain unpublished
long-term data on safety and efficacy).
- Data on adverse events that have occurred, either
from product owners or from regulatory authorities.
- Data from patients using the medical device in
the pre-marketing aid program.
- Information on clinically relevant corrective
actions such as recalls, notifications, hazard warnings.
4.3.3. Data from clinical investigation
A clinical investigation is a systematic study
performed on or in the human body for the purpose of evaluating the safety and
effectiveness of a medical device.
Clinical investigation may be performed by the
medical device owner or by a third party acting on behalf of the owner.
Clinical investigation should be designed, conducted and reported in accordance
with ISO 14155, Parts 1 and 2, Clinical Investigations of Medical Devices for
Human Subjects. or conform to an equivalent standard, and comply with local
regulations.
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For IVD medical devices: A clinical investigation
is a study conducted to establish or confirm the clinical performance of an IVD
medical device. The manufacturer must have clinical evidence to support its
clinical claims, including: diagnostic sensitivity (clinical sensitivity)
and diagnostic specificity (clinical specificity).
5. Medical Device Labelling
This is the descriptive and informational product
literature that accompanies the medical device, such as: any physician’s
manuals, pack labeling. This section should summarise or reference or contain the
following labelling data to the extent appropriate to the complexity and risk
class of the medical device, which is generally considered as “labelling”:
● Labels on the medical device and its packaging;
● Instructions for use;
● Any information and instructions given to the
patient, including instructions for any procedure the patient is expected to
perform (if applicable).
5.1. Samples of labels on the medical device and
its packaging
This is the printed, written or graphic product
information provided on or attached to one or more levels of packaging,
including the outer packaging or the outside container wrapper. If it is
physically impossible to include samples of labels (e.g. large warning labels
affixed onto an X-ray machine), alternative submission methods (e.g.
photographs or technical drawings), to the extent appropriate, will suffice to
meet the requirements of applicable legislation.
As for imported medical devices, the labeling must
include primary and secondary labels in Vietnamese.
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5.2. Instructions for use in Vietnamese
Includes instructions for the physician or end user
to safely and correctly use the medical device for its intended use. This
should include information on indications, contraindications, warnings,
precautions, potential adverse effects, alternative therapy and the conditions
that should be managed during normal use to maintain the safety and
effectiveness of the medical device.
For IVD medical devices, the instructions for use
should contain the following particulars:
- Type and code (if any) of IVD medical device.
- The intended purpose:
● what is detected or measured;
● its function (e.g. screening, monitoring,
diagnostic, aid to diagnostic, prognosis, prediction);
● Whether the same automatical medical device
(testing machine) is used;
● Whether the test is quantitative or
semi-quantitative or qualitative or nominal, etc;
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● Testing population.
- An indication that it is for in vitro diagnostic
use.
- The intended user, (e.g. lay person, health
worker, ...).
- Test principle.
- A description of the reagent, calibrators and
controls and any limitation upon their use (e.g. suitable for a dedicated
instrument only).
- A list of materials provided and a list of
special materials required but not provided.
- For IVD medical devices intended for use together
with other medical devices and/or intended for use together with devices other
than medical devices.
● Information to identify these devices, including
important performance characteristics.
● information on any known restrictions to
combinations of medical devices and equipment.
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- In use stability which may include, the storage
conditions, and shelf life following the first opening of the primary
container, together with the storage conditions and stability of working
solutions, where this is relevant. The instructions for use must specify the
shelf life of the product.
- If the IVD medical device is supplied as sterile,
it should be clearly stated that the medical device is sterile, the method of sterilization,
and instructions for handling in the event of the sterile packaging being
damaged before use.
- Information that allows the user to be informed
of any warnings, precautions, measures to be taken and limitations of use
regarding the IVD medical device. This information should cover, where
appropriate:
● warnings, precautions and/or measures to be taken
in the event of malfunction of the IVD medical device or its degradation as
suggested by changes in its appearance that may affect performance;
● warnings, precautions and/or measures to be taken
in regards to the exposure to reasonably foreseeable external influences or
environmental conditions, such as magnetic fields, external electrical and
electromagnetic effects, electrostatic discharge, radiation associated with
diagnostic or therapeutic procedures, pressure, humidity, or temperature;
● warnings, precautions and/or measures to be taken
in regards to the risks of interference posed by the reasonably foreseeable
presence of the device during specific diagnostic investigations, evaluations,
therapeutic treatment or use (e.g. electromagnetic interference emitted by the
device affecting other equipment);
● precautions related to materials incorporated
into the IVD medical device that are carcinogenic, mutagenic or toxic, or could
result in sensitisation or allergic reaction.
- Conditions for collection, handling, and
preparation of the specimen.
- Details of any preparatory treatment or handling
of the IVD medical device before it is ready for use (e.g. reconstitution,
calibration, etc.).
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● details of the nature, and frequency, of
preventative and regular maintenance (including cleaning and disinfection);
● identification of any consumable components and
how to replace them;
● information on any necessary calibration to
ensure that the IVD medical device operates properly and safely during its
intended life span;
● methods of mitigating the risks encountered by
persons involved in installing, calibrating or servicing IVD medical devices,
e.g. contaminated surfaces.
- Where relevant, recommendations for quality
control procedures.
- The metrological traceability of values assigned
to calibrators and trueness control materials, including identification of
applicable reference materials and/or reference measurement procedures of
higher order.
- Assay procedure including calculations and
interpretation of results and where relevant if any confirmatory testing should
be considered.
- Analytical performance characteristics, such as
sensitivity, specificity, and accuracy (which is a combination of trueness and
precision).
- Where relevant, clinical performance
characteristics, such as diagnostic sensitivity and diagnostic specificity.
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- Information on interfering substances or
limitations (e.g. visual evidence of hyperlipidaemia or haemolysis, age of
specimen/sample) that may affect the performance of the assay.
- Warnings or precautions to be taken related to
the disposal of the device, its accessories, and the consumables used with it,
if any. This information should cover, where appropriate:
● infection or microbial hazards (e.g. consumables
contaminated with potentially infectious substances of human origin);
● environmental hazards (e.g. batteries or
materials that emit potentially hazardous levels of radiation);
● x physical hazards (e.g. explosion).
- For IVD medical devices intended for use by lay
persons, the circumstances when the user should consult with a healthcare
professional.
- Where relevant, a bibliography.
- The name and address of the manufacturer in a
format that is recognisable and allows the location of the manufacturer to be
established, together with a telephone number and/or fax number and/or website
address to obtain technical assistance.
- Date of issue or latest revision of the
instructions for use and, where appropriate, an identification number.
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This section should summarise or reference or
contain the results of the risk analysis. This risk analysis should be based upon
international or other recognized standards, and be appropriate to the
complexity and risk class of the medical device.
6.1. Results of Risk Analysis
A list of possible hazards for these medical
devices must be prepared. Indirect risks from medical devices may result from
medical device-associated hazards, such as moving parts, which lead to
sustained injury, or from user-related hazards, such as ionizing radiation from
an X-ray machine. The evaluation of these risks against the claimed benefits of
the medical device and the method(s) used to reduce risk to acceptable levels
must be described. The individual or organization that carries out the risk
analysis must be clearly identified. The technique used to analyse risk must be
specified, to ensure that it is appropriate for the medical device and the risk
involved.
7. Manufacturing Information
(in Vietnamese or in English)
This section should summarise or reference or
contain documentation related to the manufacturing processes, including quality
assurance measures, which is appropriate to the complexity and risk class of
the medical device.
7.1. Manufacturer Information
Names, addresses of all manufacturers involved in
the manufacturing and steritise process (including those being a third party).
7.2. Manufacturing Process
Information on the manufacturing process should be
provided in sufficient detail to allow a general understanding of the
manufacturing processes. Detailed proprietary information on the manufacturing
process is not required. The information may be presented in the form of a
process flow chart showing an overview of production, controls, assembly, final
product testing, packaging of the finished medical device.
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Legal
representative
Signature (Full name, position)
Certified by seal or digital signature
ANNEX
ESSENTIAL PRINCIPLES CONFORMITY CHECKLIST
(in Vietnamese or in English)
Product Owner Name:
Product Name:
Product code (if any):
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Applicable to
the medical device?
(Yes/No)
Method of
conformity
Identity of
Specific Documents
General
requirements
Insert “Yes” if the essential principle is applicable
to the medical device;
Insert “No” if the essential principle is not
applicable to the medical device.
If the answer is ‘No’ this should be briefly
explained. For example: For a medical device that does not incorporate
biological substances, the answer to this column would be “No - The medical
device does not incorporate biological substances.”
(state the title and reference of the
standard(s), industry or in-house test method(s) used to demonstrate
compliance. For example:
- ISO 13485
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- EN ISO 18113-1
- IEC 61326-1
- IEC 61326-2-6
- IEC 60601-1)
(state the technical documentation that
demonstrates compliance to the EP, for example: the certificates, test
reports, study reports, etc.)
1.
Medical devices should be designed and manufactured
in such a way that, when used under the conditions and for the purposes
intended and, where applicable, by virtue of the technical knowledge,
experience, education or training of intended users, they will not compromise
the clinical condition or the safety of patients, or the safety and health of
users or, where applicable, other persons, provided that any risks which may
be associated with their use constitute acceptable risks when weighed against
the benefits to the patient and are compatible with a high level of
protection of health and safety.
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2.
The solutions adopted by the product owner for
the design and manufacture of the medical devices should conform to safety principles,
taking account of the generally acknowledged state of the art. When risk
reduction is required, the product owner should control the risk(s) so that
the residual risk(s) associated with each hazard is judged acceptable. The
product owner should apply the following principles in the priority order
listed:
● identify known or foreseeable hazards and
estimate the associated risks arising from the intended use and foreseeable
misuse,
● eliminate or reduce risks as far as reasonably
practicable through inherently safe design and manufacture,
● reduce as far as is reasonably practicable the
remaining risks by taking adequate protection measures, including alarms,
● inform users of any residual risks.
3.
Devices should achieve the performance intended
by the product owner and be designed, manufactured and packaged in such a way
that they are suitable for one or more of the functions within the scope of
the definition of a medical device.
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4.
The characteristics and performances referred to
in Clauses 1, 2 and 3 should not be adversely affected to such a degree that
the health or safety of the patient or the user and, where applicable, of
other persons are compromised during the lifetime of the medical device, as
indicated by the product owner, when the medical device is subjected to the
stresses which can occur during normal conditions of use and has been
properly maintained in accordance with the product owner’s instructions.
5.
The medical devices should be designed, manufactured
and packed in such a way that their characteristics and performances during
their intended use will not be adversely affected under transport and storage
conditions taking account of the instructions and information provided by the
product owner.
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6.
The benefits must be determined to outweigh any
undesirable side effects for the performances intended.
7.
Every medical device requires clinical evidence,
appropriate for the use and classification of the medical device,
demonstrating that the medical device complies with the applicable provisions
of the essential principles. A clinical evaluation should be conducted.
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Design and Manufacturing Requirements
8.
Chemical, physical and biological characterisation
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8.1
The medical devices should be designed and
manufactured in such a way as to ensure the characteristics and performance
referred to in Clauses 1 to 6 of the 'General Requirements'. Particular
attention should be paid to:
● the choice of materials used, particularly as
regards toxicity, flammability,
● physical and chemical properties of materials
used,
● the compatibility between the materials used
and biological tissues, cells, body fluids, and specimens, taking account of
the intended purpose of the medical device,
● the choice of materials used should reflect,
where appropriate, matters such as hardness, wear and fatigue strength.
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The medical devices should be designed,
manufactured and packed in such a way as to minimise the risk posed by contaminants
and residues to the persons involved in the transport, storage and use of the
medical devices. Particular attention should be paid to tissues exposed and
to the duration and frequency of exposure during the transport, storage and
use of the medical devices.
8.3
The medical devices shall be designed and
manufactured in such a way that they can be used safely with the materials,
substances and gases with which they enter into contact during their normal
use or during routine procedures; if the medical devices are intended to
administer medicinal products they shall be designed and manufactured in such
a way as to be compatible with the medicinal products concerned according to
the provisions and restrictions governing these medicinal products and that
the performance of the medicinal product is maintained in accordance with the
intended purpose of the medicinal product.
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Where a medical device incorporates, as an integral
part, a substance which, if used separately, may be considered to be a
medicinal product as defined in the relevant legislation that applies and
which is liable to act upon the body with action ancillary to that of the
medical device, the safety, quality and performance of the medical device as
a whole shall be verified, as well as the safety, quality and efficacy of the
incorporated substance in relation to the intended purpose of the medical
device. For the purposes of this paragraph, “medicinal product” includes any
stable derivative of human blood or human plasma.
8.5
The medical devices should be designed and
manufactured in such a way as to reduce as far as reasonably practicable and
appropriate the risks posed by substances that may leach or leak from the
medical device.
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Medical devices should be designed and
manufactured in such a way as to reduce as far as reasonably practicable and
appropriate risks posed by the unintentional ingress or egress of substances
into or from the medical device taking into account the medical device and
the nature of the environment in which it is intended to be used.
9.
Infection and microbial contamination
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The medical devices and manufacturing processes should
be designed in such a way as to eliminate or to reduce as far as reasonably
practicable and appropriate the risk of infection to any person. The design
should:
● allow easy handling, and, where necessary:
● reduce as far as reasonably practicable and
appropriate any microbial leakage from the medical device and/or microbial
exposure during use;
● prevent microbial contamination of the medical
device, or specimen where applicable, by the patient, user or other person.
9.2
Where a medical device incorporates substances of
biological origin, the risk of infection must be reduced as far as reasonably
practicable and appropriate by selecting appropriate sources, donors and
substances and by using, as appropriate, validated inactivation, conservation,
test and control procedures. This may not apply to certain IVD medical device
if the activity of the virus and other transmissible agent are integral to
the intended purpose of the IVD medical device or when such elimination or
inactivation process would compromise the performance of the IVD medical
device.
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9.3
Products incorporating non-viable tissues, cells
and substances of animal origin falling within the definition of a medical
device, shall originate from animals that have been subjected to veterinary
controls and surveillance adapted to the intended purpose of the tissues. The
product owner is required to retain information on the geographical origin of
the animals. Processing, preservation, testing and handling of tissues, cells
and substances of animal origin shall be carried out so as to provide optimal
safety. In particular, safety with regard to viruses and other transmissible
agents shall be addressed by implementation of validated methods of
elimination or inactivation in the course of the manufacturing process. This
may not apply to certain IVD medical device if the activity of the virus and
other transmissible agent are integral to the intended purpose of the IVD
medical device or when such elimination or inactivation process would compromise
the Performance of the IVD medical device.
9.4
For products incorporating cells, tissues and derivatives of microbial
or recombinant origin falling within the definition of a medical device, the
selection of sources/donors, the processing, preservation, testing and
handling of cells, tissues and derivatives of such origin shall be carried
out so as to provide optimal safety. In particular, safety with regard to
viruses and other transmissible agents shall be addressed by implementation
of validated methods of elimination or inactivation in the course of the
manufacturing process. This may not apply to certain IVD medical device if
the activity of the virus and other transmissible agent are integral to the
intended purpose of the IVD medical device or when such elimination or
inactivation process would compromise the Performance of the IVD medical
device.
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9.5
For products incorporating non-viable human
tissues, cells and substances falling within the definition of an IVD medical
device, the selection of sources, donors and/or substances of human origin,
the processing, preservation, testing and handling of tissues, cells and
substances of such origin shall be carried out so as to provide optimal
safety. In particular, safety with regard to viruses and other transmissible
agents shall be addressed by implementation of validated methods of
elimination or inactivation in the course of the manufacturing process. This
may not apply to certain IVD medical device if the activity of the virus and
other transmissible agent are integral to the intended purpose of the IVD
medical device or when such elimination or inactivation process would
compromise the performance of the IVD medical device.
9.6
Medical devices labeled as having a special
microbiological state shall be designed, manufactured and packed to ensure
they remain so when placed on the market and remain so under the transport
and storage conditions specified by the product owner.
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9.7
Medical devices delivered in a sterile state
shall be designed, manufactured and packed to ensure that they remain sterile
when placed on the market and remain sterile, under the transport and storage
conditions indicated by the product owner.
9.8
Medical devices labeled either as sterile or as
having a special microbiological State shall have been processed,
manufactured and, if applicable, sterilised by appropriate, validated
methods.
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9.9
Medical devices intended to be sterilised shall be
manufactured in appropriately controlled (e.g. environmental) conditions.
9.10
Packaging systems for non-sterile medical devices
shall keep the product at the level of cleanliness stipulated and, if the
medical devices are to be sterilised prior to use, minimise the risk of
microbial contamination; the packaging system shall be suitable taking
account of the method of sterilisation indicated by the product owner. The
medical device shall be produced in appropriately controlled conditions.
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9.11
The packaging and/or label of the medical device
shall distinguish between identical or similar Products placed on the market
in both sterile and non-sterile condition.
10.
Manufacturing and environmental properties
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10.1
lf the medical device is intended for use in
combination with other medical devices or equipment, the whole combination,
including the connection System shall be safe and shall not impair the
specified performance of the medical devices, or equipment with which it is
used. Any restrictions on use applying to such combinations shall be
indicated on the label and/or in the instructions for use.
10.2
Medical devices shall be designed and
manufactured in such a way as to remove or reduce as far as reasonably
practicable and appropriate:
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● risks connected with reasonably foreseeable
external influences or environmental conditions, such as magnetic fields,
external electrical and electromagnetic effects, electrostatic discharge,
pressure, humidity, temperature or variations in pressure and acceleration;
● the risks connected to their use in conjunction with materials,
substances and gases with which they may come into contact during normal
conditions of use;
● the risks of accidental penetration of
substances into the medical device;
● the risk of incorrect identification of
specimens;
● the risks of reciprocal interference with other
medical devices normally used in the investigations or for the treatment
given;
● risks arising where maintenance or calibration
are not possible (as with implants), from ageing of materials used or loss of
accuracy of any measuring or control mechanism.
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Medical devices shall be designed and
manufactured in such a way as to minimise the risks of fire or explosion
during normal use and in single fault condition. Particular attention shall
be paid to medical devices whose intended purpose includes exposure to or use
in association with flammable substances or substances which could cause
combustion.
10.4
Medical devices must be designed and manufactured
in such a way as to facilitate the safe disposal of any waste substances.
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11.
Medical devices with a diagnostic or measuring
function
11.1
Medical devices with a measuring function shall
be designed and manufactured in such a way as to provide sufficient accuracy,
precision and stability for their intended purpose. The limits of accuracy,
precision and stability shall be indicated by the product owner.
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11.2
Medical devices shall be designed and
manufactured in such a way as to provide sufficient accuracy, precision and
stability for their intended purpose, based on appropriate scientific and
technical methods. In particular the design shall address the sensitivity,
specificity, trueness, repeatability, reproducibility, control of known
relevant interference and limits of detection, as appropriate.
11.3
Where the performance of medical devices depends
on the use of calibrators and/or control materials, the traceability of values
assigned to such calibrators and/or control materials shall be assured
through a quality management system.
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11.4
Any measurement, monitoring or display scale
shall be designed and manufactured in line with ergonomic principles, taking
into account of the intended purpose of the medical device.
11.5
Wherever possible values expressed numerically
shall be in commonly accepted, standardised units, and understood by the
users of the medical device.
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12.
Protection against radiation
12.1
General
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12.1.1
Medical devices shall be designed and
manufactured and packaged in such a way that exposure of patients, users and
other persons to any emitted radiation shall be reduced as far as practicable
and appropriate, compatible with the intended purpose, whilst not restricting
the application of appropriate specified levels for therapeutic and
diagnostic purposes.
12.2
Intended radiation
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12.2.1
Where medical devices are designed to emit hazardous,
or potentially hazardous, levels of visible and/or invisible radiation
necessary for a specific medical purpose the benefit of which is considered
to outweigh the risks inherent in the emission, it shall be possible for the
User to control the emissions. Such medical devices shall be designed and
manufactured to ensure reproducibility of relevant variable parameters within
an acceptable tolerance.
12.2.2
Where medical devices are intended to emit potentially
hazardous, visible and/or invisible radiation, they shall be fitted, where
practicable, with visual displays and/or audible warnings of such emissions.
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12.3
Unintended radiation
12.3.1
Medical devices shall be designed and manufactured
in such a way that exposure of patients, users and other persons to the
emission of unintended, stray or scattered radiation is reduced as far as
practicable and appropriate.
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12.4
Instructions for use.
12.4.1
The operating instructions for medical devices
emitting radiation shall give detailed information as to the nature of the
emitted radiation, means of protecting the patient and the user and on ways
of avoiding misuse and of eliminating the risks inherent in installation.
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12.5
lonising radiation.
12.5.1
Medical devices intended to emit ionising
radiation shall be designed and manufactured in such a way as to ensure that,
where practicable, the quantity, geometry and energy distribution (or quality)
of radiation emitted can be varied and controlled taking into account the
intended purpose.
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12.5.2
Medical devices emitting ionising radiation
intended for diagnostic radiology shall be designed and manufactured in such
a way as to achieve appropriate image and/or output quality for the intended
medical purpose whilst minimising radiation exposure of the patient and user.
12.5.3
Medical devices emitting ionising radiation,
intended for therapeutic radiology shall be designed and manufactured in such
a way as to enable reliable monitoring and control of the delivered dose, the
beam type and energy and where appropriate the energy distribution of the
radiation beam.
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13.
Requirements for medical devices connected to or equipped
with an energy source.
13.1
Medical devices incorporating electronic
programmable Systems, including software, shall be designed to ensure the
repeatability, reliability and performance of these Systems according to the
intended purpose. In the event of a single fault condition in the System,
appropriate means shall be adopted to eliminate or reduce as far as
practicable and appropriate consequent risks.
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13.2
For medical devices which incorporate software or
which are medical software in themselves, the software shall be validated
according to the state of the art taking into account the principles of
development lifecycle, risk management, validation and verification.
13.3
Medical devices where the safety of the patients
depends on an internal power supply shall be equipped with a means of
determining the state of the power supply.
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13.4
Medical devices where the safety of the patients
depends on an external power supply shall include an alarm system to signal any
power failure.
13.5
Medical devices intended to monitor one or more
clinical parameters of a patient shall be equipped with appropriate alarm
systems to alert the user of situations which could lead to death or severe
deterioration of the patient’s state of health.
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13.6
Medical devices shall be designed and
manufactured in such a way as to reduce as far as practicable and appropriate
the risks of creating electromagnetic interference which could impair the
operation of this or other medical devices or equipment in the vicinity Where
the medical device is located.
13.7
Medical devices shall be designed and
manufactured in such a way as to provide an adequate level of intrinsic
immunity to electromagnetic disturbance to enable them to operate as
intended.
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13.8
Protection against electrical risks
13.8.1
A medical device shall be designed and
manufactured in a way that ensures that, as far as possible, a patient, or any
other person is protected against the risk of accidental electric shock when
it is installed and maintained as indicated by the product owner, is being
used under normal conditions of use and in the event of a single fault
condition (SFC).
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14.
Protection against mechanical risks
14.1
Medical devices shall be designed and
manufactured in such a way as to protect the patient and User against
mechanical risks associated with the use of the medical device.
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14.2
Medical devices shall be designed and
manufactured in such a way as to reduce to the lowest practicable level the
risks arising from vibration generated by the medical devices, taking account
of technical progress and of the means available for limiting vibrations,
particularly at source, unless the vibrations are part of the specified
performance.
14.3
Medical devices shall be designed and
manufactured in such a way as to reduce to the lowest practicable level the
risks arising from the noise emitted, taking account of technical progress
and of the means available to reduce noise, particularly at source, unless
the noise emitted is part of the specified performance.
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14.4
Terminals and connectors to the electricity, gas
or hydraulic and pneumatic energy supplies which the user has to handle shall
be designed and constructed in such a way as to minimise all possible risks.
14.5
Accessible parts of the medical devices
(excluding the parts or areas intended to supply heat or reach given temperatures)
and their surroundings shall not attain potentially dangerous temperatures
under normal use.
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15.
Protection against the risks posed to the patient
by supplied energy or substances
15.1
Medical devices for supplying the patient with energy
or substances shall be designed and constructed in such a way that the
delivered rate and/or amount can be set and maintained accurately enough to
guarantee the safety of the patient and of the user.
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15.2
Medical devices shall be fitted with the means of
preventing and/or indicating any inadequacies in the delivered rate and/or
amount which could pose a danger. Medical devices shall incorporate suitable
means to prevent, as far as possible, the accidental release of dangerous
levels of energy from an energy and/or substance source.
15.3
The function of the controls and indicators shall
be clearly specified on the medical devices. Where a medical device bears
instructions required for its operation or indicates operating or adjustment
parameters by means of a visual system, such information shall be
understandable to the user and, as appropriate, the patient.
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16.
Active implantable medical devices
16.1
An active implantable medical device shall express
clear information that can be used to identify:
● the type of medical device;
● the product owner of the medical device; and
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16.2
The identifier shall be readable without the need
for surgery to the person in whom the medical device is implanted.
17.
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17.1
Such medical devices shall be designed and manufactured
in such a way that they perform appropriately for their intended purpose
taking into account the skills and the means available to users and the
influence resulting from variation that can reasonably be anticipated in
user’s technique and environment. The information and instructions provided
by the product owner shall be easy for the user to understand and apply.
17.2
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17.3
Such medical devices shall, where reasonably
possible, include a procedure by which the user can verify that, at the time
of use, the medical device will perform as intended by the product owner.
18.
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18.1
The following information shall be provided with a
medical device, having regard to the training and knowledge of potential
users of the medical device, etc.
19.
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19.1
Clinical investigations on human subjects shall
be carried out in accordance with the spirit of the Helsinki Declaration.
This includes every step in the clinical investigation from first
consideration of the need and justification of the study to publication of
the results.
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