Compliance

Each In-Vitro Device manufacturer must develop their own compliance program which addresses their particular device categories and business needs. The following are general steps to compliance:

  • Determination of the applicable standards (European, International or National)
  • Assessment and classification of your device (depending on the specific function of an In-Vitro Diagnostic Medical Device and whether or not it is listed in Annex II)
  • Identification of the appropriate conformity assessment module according to your device classification
  • Preparation of a “Technical File” including a user manual (Annex III, section 3)
  • Implementation of “Quality Assurance System” (Annex III, section 4)
  • Selection of a Notified Body within the European Economic Area to perform the official conformity assessment tasks
  • Preparation of an “EC Declaration of Conformity”
  • Affixing of the CE Marking in accordance with the directive

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community

The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in the directive are published in the “Official Journal of the European Community”. While other national, regional or international standards can be used as well, European Standards are preferred since they are presumed by the European Commission to address the “essential requirements” contained in the directive.

Manufacturers should test your device, determine its conformance to the appropriate legal requirements and construct a corresponding Technical File that should be available in the European Economic Area. Manufacturers also need to affix the required “CE Marking” Logo to the device before placement in the market. In many cases, manufacturers can self-certify that their devices meet the legal requirements contained in the directive. In most instances, such a self-certification requires the use of European Standards.

The “Declaration of Conformity” must be prepared and must contain the following information:

  • The manufacturer’s name and full address, telephone, fax numbers and e-mail
  • The European Directive complied with
  • Device identification
  • Standards used to verify compliance with the directives
  • Name of “Notifying Body” and its identification number
  • The “Authorized Representative’s” name and full address, telephone, fax numbers and e-mail

The “Declaration of Conformity” and the “Technical Files” need only be written in “English”. However, instruction manuals need to be in the local language of the end user.

The European Competent Authorities are the local regulating bodies in each member state responsible for fulfilling the obligations of market control. All IVDs require notification to the Competent Authorities and a European Authorized Representative for each device placed on the market. The Notified Body will issue the appropriate certification after an exhaustive assessment to ensure that all relevant requirements have been met. Subsequently, manufacturers can place the CE marking on their devices demonstrating their compliance with the requirements.

Notification procedure for IVDs:

Any manufacturer who places a device on the European market has to notify the competent authorities of each Member State concerned by that placing on the market

For non-EU manufacturers:

  • This action can only be completed through a designated European Authorized Representative who will notify the competent authorities of that placing on the European Economic Area,
  • European Authorized Representative will then equip a non-EU manufacturer with “A certificate of CE Registration” which will demonstrate the submission of files to the European Authorities. From this point a non-EU manufacturer may place the device on the market

For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.

Non-Compliance

The directive portrays European Law enforced within the EEA; non-compliance with the directive’s requirements will result in the removal of the device from the market and the revoking of the CE marking affixed on the device.


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