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Directive 93/42/EEC states the following conformity assessment routes for class Is devices:
- Annex VII and IV
- Annex VII and V
- Annex VII and VI
As it is not possible to test the aspects concerning sterilization Annex VII and V will in practice be the only possible conformity assessment route. For this reason the above diagram and below explanatory text only deal with Annex VII and V.
To affix the CE marking to devices falling within class Is, the manufacturer shall follow the conformity assessment procedure below:
- EC Declaration of Conformity (Annex VII) combined with production quality assurance (Annex V)
Under items 1 & 2 below follows a more detailed description of the arrangements to be made by the manufacturer in order to be in compliance with the requirements of Directive 93/42/EEC.
Re. 1 - Annex VII - EC Declaration of Conformity
The manufacturer prepares the technical documentation which is to make it possible to assess whether the devices in question meet the requirements of the Directive. The technical documentation shall include:
- 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 harmonised standards applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if harmonised standards 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
- the label and instructions for use
The manufacturer places the technical documentation at the disposal of the national competent authorities for a period ending at least five years after the last product has been manufactured. The documentation shall only be submitted to the competent authorities on request.
In addition to the above requirement for technical documentation and a declaration of conformity, the manufacturer is obliged to institute and keep up to date a post-marketing surveillance and vigilance system. The aim of such a system is to ensure a systematic procedure for reviewing experience gained from the devices after they have been put on the market and thereby correction of possible malfunctions of the devices.
The manufacturer shall notify the competent authorities of the following incidents immediately after learning about them:
- information on incidents which might lead to or might have led to the death of a patient or user or a serious deterioration in his state of health
- information on recall of devices including information on the reason for recalling the devices.
Re. 2 - Annex V - production quality assurance
To affix the CE marking to devices falling within class Is, the manufacturer shall, apart from meeting the abovementioned requirements of Annex VII, follow the conformity assessment procedure in Annex V regarding the aspects of manufacture concerned with securing and maintaining sterile conditions.
Pratically, the manufacturer shall do the following:
- lodging of application with a notified body (application forms will be found under "Documents" on DGM's website)
- the manufacturer prepares and implements quality system procedures containing an adequate description of the processes and procedures which will be used, particularly as regards sterilization
- the quality system procedures are submitted to the notified body which on the basis of the documentation prepares a pre-evaluation report to the manufacturer
- the notified body carries out an audit at the manufacturer's (or subcontractor) address to ensure that the quality system meets the requirements of the Directive. The audit will only include the parts of the quality system bearing on sterilisation
- the manufacturer shall inform the notified body of any plan for substantial changes to the quality system
- the manufacturer implements a post-marketing surveillance and vigilance system
- when the audit has been carried out and all possible nonconformities have been closed, certificate in accordance with Annex V is issued
- on the basis of the technical documentation and the certificate issued by the notified body, the manufacturer prepares a declaration of conformity ensuring and declaring that the devices in question meet the relevant requirements of the Directive as it has been transposed in the countries where the devices are marketed
- the manufacturer affixes CE marking to the devices
- hereafter surveillance audits are carried through biannually or annually in order to ensure that the manufacturer permanently meets the requirements of Annex V.
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