Stage 1: Identify and obtain a copy of the applicable Directive(s)

This can be obtained by visiting:

• The BSI website
• The EU website
• A Notified Body website, such as AMTAC Certification Services.

  The Directive was implemented in January 1995 has been mandatory since June 1998. It applies to all legally defined manufacturers who place on the market a medical device or medical device accessory.
  Non EU located manufacturers who wish to sell in the EU must also apply the CE Marking to their products and may be subjected to a Notified Body audit.
  

  Stage 2: Device Risk Classification/

  Classification is concerned with the following points:

  • The nature of the device (active, re-usable etc)
  • How long the device will be in contact with the body
  • The part of the body that the device will be in contact with
  • How the device will attach to or penetrate the body
  • The intended purpose for the device.

  It is the manufacturer's responsibility to classify the device, but the Notified Body must agree with this classification, validating the evidence that the stated purpose is actually viable.

  
  Stage 3 and 4: Choosing a Notified Body

  Refer to the separate section on Notified Bodies which outlines the services that Notified bodies provides contacts in Scotland.

  
  Stage 5: Conformity Options

  All devices, except those classified Class I, require an audit by an appropriate Notified Body. The Directive details the available conformity assessment procedures and offers the manufacturer a number of options for conformity. It is a good idea to ensure that the option chosen meets your mandatory requirements and is also beneficial from a manufacturing perspective. Liaison with your chosen Notified Body is advised.

  
  Stage 7: Implement your conformity route

  Generally, manufacturers are advised to use the relevant Harmonised Standard to interpret the requirements of the Directive with regard to their EC Declaration of Conformity.

  Further details are available from the Notified Body, who will advise on implemention in conjunction with the harmonised standards. This will additionally permit manufacturers to be registered against ISO 9000/EN 46000 as part of the audit process. The regulatory, management and marketing requirements can be combined in one procedure. It is worth noting that good project management of the implementation programme and incorporation of the statutory compliance issues of the Directive is advisable.

  If you have already met other external requirements (e.g. FDA) and have existing systems designed it is often a good idea cross-reference your compliance systems, which will aid in avoiding duplication, unnecessary expense and system conflicts.

  
  Stage 8: Ensure your devices comply with the 'Essential Requirements'

  Demonstration that your device is both safe and achieves its intended purpose must be made to your Notified Body, thereby satisfying Annex I of the Directive, 'Essential Requirements'.
  Independent testing is not always required. The manufacturer must demonstrate satisfactory risk analysis and methodology.

  Stage 9: Compile and validate all appropriate documentation It is mandatory to comply with the Directive but it is also a good opportunity to develop a sound quality management system that will benefit your organisation.
  Development of internally and assessment formed documentation will save on administration, with the use of checklists and flow charts. Details of this can be found in appropriate ISO quality manuals.
  It is recommended that an internal audit be carried out before contacting your Notified Body for assessment. Care should be taken to ensure that all aspects of the Directive are considered and acted upon according to your product Classification.

  
  Stage 9: Develop product labelling and instructions

  Device classification is dependent upon the manufacturers intended purpose and all aspects will be covered by your audit, including labelling and product instructions. It is possible that other marketing material, such as product catalogues, may be considered. The requirements for labelling and other information to be supplied by the manufacturer are detailed in the Directive.

  Areas to consider are:
  

  • Who the ultimate user will be
  • What language the user speaks
  • National requirements.

  It is recommended that symbols be should be used wherever possible, appropriate symbols can be found in EN 980:1997 'Graphical Symbols for Use in the Labelling of Medical Devices'. These symbols should be displayed in addition to your CE marking, as detailed in the Directive.

  
  Stage 10: The Notified Body Audit

  Approximately 4 to 8 weeks prior to the audit date you will have to ask your Notified Body to review your quality system documentation. This allows you some time to implement any required corrective actions.
  Audit duration will typically be between three and ten days dependent upon the size of your organisation, the number of device families involved and their classification.

  Subcontractors, control of components and critical services will be addressed. If these subcontractors manufacture major device components, or supply critical parts or services which could detrimentally effect the efficacy of your device(s), then your Notified Body may need to audit these organisations as well.

  Any non-conformities found during the initial audit will given a time-line within which appropriate corrective action can be undertaken. As soon as all non-compliances have been satisfactorily cleared, the Notified Body will recommend that the CE Marking and any other associated registration (ISO 9000) be applied to your product. Regular surveillance is required by your Notified Body, this is often carried out once or twice a year.

  Once in possession of device CE marking you will have the freedom to access the market place in all EU Member States.

  
  New Approach Directives
  The New Directives will affect the following areas of the Medical Device Industry: