Carisa,
you need to comply with Annex VII of the
MDD 93/42/EEC:
In short: you have to do the same things, as if you produce a class IIa device, but you do not need to involve a notified body and you do not need to have a certified quality management system - but you need some QM system to manage the requirements of the MDD:
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.
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 years after the last product has been manufactured.
Where neither the manufacturer nor his authorized representative are established in the Community, this obligation to keepthe technical documentation available must fall to the person(s) who place(s) the product on the Community market.
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-assemblies, circuits, etc.,
— the descriptions and explanations necessary to understand the above mentioned drawings and diagrams and the operations of the product,
— the results of the risk analysis 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 be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(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.
The manufacturer shall institute and keepupto 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 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 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 manufacturer.
Class I Medical Device - What is in a CE Marking Self-Declaration
Re: Class I Medical Device - CE marking self-declaration
Re: Class I Medical Device - CE marking self-declaration
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