To affix CE marking to devices falling within class IIa, the manufacturer shall follow one of the four conformity assessment procedures below:

• EC Declaration of Conformity (Annex VII) combined with production quality assurance (Annex V)
• EC Declaration of Conformity (Annex VII) combined with product quality assurance (Annex VI)
• EC Declaration of Conformity (Annex VII) combined with EC verification (Annex IV)
• Full quality assurance (Annex II)

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

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

The manufacturer follows the procedure of Annex V and 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 a production quality system
• the quality system shall include an adequate description of:
  • the manufacturer's quality objectives
  • the organization of the business, in particular the organizational structures, the responsibilities of the managerial staff and their organizational authority 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
  • the inspection and quality assurance techniques at the manufacturing stage, 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
  • the appropriate tests and trials to be carried out before, during and after manufacture and the frequency with which they will take place
  • test equipment used
  • documentation for calibration of the test equipment ensuring traceability
• 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 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 the 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.

The manufacturer follows the procedure of Annex VI and 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 a product quality system system
• the quality system shall include an adequate description of:
  • the quality objectives and the organizational structure, the responsibilities and powers of the managerial staff with regard to product quality
  • the examinations and tests that will be carried out after manufacture
  • the methods of monitoring the efficient operation of the quality system
  • the quality records, such as reports concerning inspections, tests, calibration and the qualification of the staff concerned
• the quality manual is 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 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 VI 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 the 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 VI.

The manufacturer follows the procedure of Annex IV and 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 a description of the manufacturing process, including a description of the provisions implemented to ensure homogeneous production and that the product is in compliance with the essential requirements of the Directive
• the manufacturer informs the notified body whether the EC verification should be carried out by examining and testing every product or by examining and testing products on a statistical basis
• the manufacturer implements a post-marketing surveillance and vigilance system
• the notified body carries out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of Directive 93/42/EEC. At the choice of the manufacturer, the verification is carried out either by examining and testing every product or by examining and testing products on a statistical basis (verification of every product is most common when the manufacturer produces a limited number of devices, whereas statistical control is most common in connection with verification of large, homogeneous lots, e.g. condoms)
• when compliance with the requirements of the Directive can be ascertained, the notified body issues a written EC verification certificate concerning the products/lots in question
• 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 the CE marking to the devices

The manufacturer follows the procedure of Annex II and 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 a quality system for the design, manufacture and final inspection of the products concerned
• the quality system shall include an adequate description of:
  • the manufacturer's quality objectives
  • the organization of the business, in particular the organizational structures, the responsibilities of the managerial staff and their organizational authority where quality of design and 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 design and of product, including control of products which fail to conform
  • the inspection and quality assurance techniques at the manufacturing stage, 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
  • the appropriate tests and trials to be carried out before, during and after manufacture and the frequency with which they will take place
  • test equipment used
  • documentation for calibration of the test equipment ensuring traceability
• further the quality system shall contain procedures for the preparation of:
  • 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 abovementioned 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 the 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 shall 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 quality manual is 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 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 II 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 the 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 II.