Path to EU Market Entrance: Compliance
Each In-Vitro Device manufacturer must develop their own EU 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, following the Commission, the only ones giving a presumption of compliance with the “essential requirements” contained in the Directive.
Manufacturers should test the device, determine its conformance to the appropriate legal requirements and construct a corresponding Technical File, that should be available for inspection in the European Economic Area. Manufacturers also need to affix the required “CE Marking” Logo to the device before placing on 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 correspondence with 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 followed
- Name of “Notified 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 File” shall be written in “English”. However, instruction manuals and labels need to be in the official national language of the end user.
The European Competent Authorities are the local regulating bodies in each member state and they ensure the market control. All IVDs require notification to the Competent Authorities and a European Authorized Representative for each device placed on the market. For Self-testing, and devices listed in Annex II list A and B, 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.
- The Directive: IVDD 98/79/EEC
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
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