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

• EC Type-Examination (Annex III) combined with production quality assurance (Annex V)
• EC Type-Examination (Annex III) combined with EC verification (Annex IV)
• Full quality assurance (Annex II)

Re. 1 - EC Type-Examination

The manufacturer follows the procedure of Annex III and shall do the following:

• lodging of application with a notified body (application forms will be found under "Documents" on DGM's website)
• preparation of product documentation which is to make it possible to understand the design, the manufacture and the performances of the product. The documentation shall contain in particular:
  • a general description of the type including any variants planned
  • design drawings, methods of manufacture envisaged, in particular as regards sterilization, and diagrams of components, sub-assemblies, circuits, etc.
  • the descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operation of the product
  • a list of harmonised standards applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if harmonised standards have not been applied in full
  • the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out
  • a statement indicating whether or not the device incorporates, as an integral part, a medicinal product and data on the tests conducted in this connection
  • the clinical data
  • the draft label and, where appropriate, instructions for use
• the notified body examines and assesses the documentation and verifies that the type has been manufactured in conformity with the documentation
• the notified body carries out appropriate inspections and tests to verify whether the solutions adopted by the manufacturer meet the essential requirements of the Directive
• if the type conforms to the provisions of the Directive, the notified body issues an EC type-examination certificate
• the manufacturer engages to inform the notified body of any significant change made to the approved product
• the manufacturer engages to keep the technical documentation together with copies of EC type-examination certificates for a period ending at least five years after the last device has been manufactured.

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.

Re 3 - Annex IV - EC verification

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

Alternatively, the manufacturer follows the procedure of Annex II.

Re. 4 - Annex II - full quality assurance

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 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 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

• a description of the design, manufacture and performances of the product

When the notified body ascertains that the product meets the relevant requirements of the Directive, the audit in accordance with Annex II 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 products, and surveillance audits are hereafter carried through in order to ensure that the manufacturer permanently meets the requirements of Annex II.

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.