Let me try...
I do not know exactly where a surgical mask fix in the directive.
I suggest: Class 1 None invasive device. Annex III Clasification. (Not sure
)
Therefore according to article 9:
Article 11.5 -A Annex VII
The manufacturer shall draw up the EC declaration required before placing the divice on the market.
Annex VII
ANNEX VII
EC DECLARATION OF CONFORMITY
1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorized representative established in the Community who fulfils the obligations imposed by Section 2 and, in the
case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions
of this Directive which apply to them.
2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community must make this documentation, including the
declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five vears after the last product has been manufactured.
Where neither the manufacturer nor his authorized representative are established in the Community, this
obligation to keep the technical documentation available must fall to the person(s) who place(s) the
product on the Community market.
3.
The technical documentation must allow assessment of the conformity of the product with the
requirements of the Directive. It must include in particular:
- a general description of the product, including any variants planned,
- design drawings, methods of manufacture envisaged and diagrams of components, sub-a:qemblics,
circuits, etc.,
- the descriptions and explanations necessary to understand the abox.cmentioned drawings and diagrams
and the operations of the product,
- the results of the risk anaysis and a list of the standards referred to in Article 5, applied in full or in part,
and descriptions of the solutions adopted to meet the essential requirements of the Directive if the
standards referred to in Article 5 have not been applied in full,
- in the case of products placed on the market in a sterile condition, description of the methods used,
- the results of the design calculations and of the inspections carried out, etc.; if the device is to he
connected to other device(s) in order to operate as intended, proof must he provided that it conforms to
the essential requirements when connected to any such dcvice(s) having the characteristics specified by
the manufacturer,
- the test reports and, where appropriate, clinical data in accordance with Annex X,
- the label and instructions for use.
4. The manufacturer shall institute and keep up to date a systematic procedure to review experience gained
from devices in the post-production phase and to implement appropriate means to apply any necessary
corrective actions, taking account of the nature and risks in relation to the product. He shall notify the
competent authorities of the following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any
inadequacy in the labelling or the instructions for use which might lead to or migln have led to the
death of a patient or user or to a serious deterioration in his stare of health;
(ii) any technical or medical reason connected with the characteristics on the performance of a device
for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same
type by the manufacrurer
5. With products placed on the market in sterile condition and Class I devices with a measuring function, the manufacturer must observe not only the provisions laid down in this Annex but also one of the procedures
referred to in Annex IV,
V or Vi.
Application of the abovementioned Annexes and the intervention by the notified body is limited to:
-
in the cast of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions,
Medical Device Directive - MDD
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- in the cast of devices with a measuring function, only the aspects of manufacture concerned with the
conformity, of the products with the metrological requirements.
Section 6.1. of this Annex is applicable.
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ANNEX VEC DECLARATION OF CONFORMITY
(Production quality assurance)
1. The manufacturer must ensure application of the
quality system approved for the manufacrure of the
products concerned and carry out the final inspection, as specified in Section 3, and is subject to the
Community surveillance referred to in Section 4.
2. The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the
obligations imposed by Section I ensures and declares that the products concerned conform to the type
described in the EC type-examination certificate and meets the provisions of this Directive which apply to
them.
The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written
declaration of conformity. This declaration must cover a given number of identified specimens of the
products manufactured and must be kept by the manufacturer.
3. Quality system
3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body.
The application must include:
- the name and address of the manufacturer,
- all the relevant information on the product or product category covered by the procedure,
- a written declaration that no application has been lodged with any other notified body for the same
products,
- the documentation on the quality system,
- an undertaking to fulfil the obligations imposed by the quality system is approved,
- an undertaking to maintain the practicability and effectiveness of the approved qualiry system,
- where appropriate, the technical documentation on the types approved and a copy of the EC typecxamination
certificates,
- an undertaking by the manufacrurer to institute and keep up to date a systematic procedure to review
experience gained from devices in the post-production phase and to implement appropriate means to
apply any necessary corrective action. This undertaking must include an obligation for the manufacturer
to notify the competent authorities of.the following incidents immediately on learning of them:
(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well as any
inadequacy in the lab ' ailing or the instructions for use which might lead to or might have led to the
death of a patient or user or to a serious deterioration in his state of health;
(ii) any technical or medical'reason connected with the characteristics or performance of a device for the
reasons referred to in subparagraph (i) above leading to a systematic recall of devices of the same
type by the manufacturer.
3.2. Application of the quality system must ensure that the products conform to the type described in the EC
type-examination certificate.
All the elements, requirements and provisions adopted by the manufacturer for his quality system must be
documented in a systematic and orderly manner in the form of written policy statements and procedures.
This quality system documentation must permit uniform interpretation of the quality policy and procedures
such as qualit). programmes, plans, manuals and records.
It must include in particular an adequate description of:
(a) the manufacturer's quality objectives;
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Page 29 of 46 pages
(b) the organization of the business and in particular:
- the organization nal structures, the responsibilities of the managerial staff and their organizational
authoriry where manufacture of the products is concerned,
- the methods of monitoring the efficient operation of the quality system and in particular its ability
to achieve the desired quality of product, including control of products which fail to conform;
(c) the inspection and quality assurance techniques at the manufacturing stage and in particular:
- the processes and procedures which will be used, particularly as regards sterilization, purchasing
and the relevant documents,
- the product identification procedures drawn up and kept up to date from drawings, specifications
or other relevant documents at every stage of manufacture;
(d) the appropriate tests and trials to be carried out before, during and after manufacture, the
frequency with which they will take place, and the test equipment used; it must be possible
adequately to trace back the calibration of the test equipment.
3.3. The notified body must audit the quality system to determine whether it meets the requirements referred
to in Section 3.2. It must presume that quality systems which implement the relevant harmonized
standards conform to these requirements.
The assessment team must include at least one member with past experience of assessments of the
technology concerned. The assessment procedure must include an inspection on the manufacturer's
premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers to inspect the
manufacturing processes.
The decision must be notified to the manufacturer after the final inspection and contain the conclusions of
the inspection and a reasoned assessment.
3.4. The manufacturer must inform the notified -body which approved the qualiry system of any plan for
substantial changes to the quality system.
The notified body must assess the changes proposed and verify whether after these changes the quality
system still meets the requirements referred to in Section 3.2.
After the abovementioned information has been received, the decision is notified to the manufacturer. It
must contain the conclusions of the inspection and a reasoned assessment.
4. Surveillance
4.1. The aim of surveillance is to ensure that the manufacrurer duly fulfils the obligations imposed by the
approved quality system.
4.2. The manufacturer authorizes the notified body to carry out all the necessary inspections and must supply
it with all relevant information, in particular:
- the documentation on the quality system,
- the data stipulated in the part of the quality system relating to manufacture, such as inspection reports
and rest data, calibration data, qualification reports of the personnel concerned, etc.
4.3. The notified body must periodically carry out appropriate inspections and assess. ments to make sure that
the manufacturer applies the approved quality system and supply the manufacturer with an assessment
report.
4.4. In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits,
the notified body may, where necessary, carry out or ask for tests in order to check that the quality system
is working properly. It must provide the manufacturer with an inspection report and, if a test has been
carried out, with a rest report.
5. Administrative provisions
5.1. The manufacturer must, for a period ending at least five years after the last product has been
manufactured, make available to the national authorities:
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- the declaration of conformity,
- the documentation referred to in the fourth indent of Section 3.1,
- the changes referred to in Section 3.4,
- the documentation referred to in the seventh indent of Section 3.1,
- the decisions and reports from the notified body as referred to in Sections 4.3 and 4.4,
- where appropriate, the type-examination certificate referred to in Annex III.
5.2. The notified body must make available to the other notified bodies, on request, all relevant information
concerning the quality system approvals issued, refused or withdrawn.
6. Application to devices in Class Ila
In line with Article 11 (2), this Annex may apply to products in Class Ila, subject to the following
exemption:
6.1. in derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer
ensures and declares that the products in Class lla are manufactured in conformity with the technical
documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which
apply to them.
