CE Mark

The CE mark (Conformité Européenne) is a compliance symbol indicating that a diagnostic device conforms to 98/79/CE Directive requirements, having fulfilled the conformity assessment procedure(s).

The 98/79/CE Directive harmonizes the EEC Countries regulations and, starting on December 7, 2003, obliges the in vitro diagnostics (IVD) manufacturers to place on the European Unity market CE-marked products only. Such devices “must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be acceptable when weighted against the benefits to the patient and be compatible with a high level of protection of health and safety” (98/79/CE Directive, Annex I, item A1).

Classification of IVD devices reflects accuracy of the diagnostic information requested: highest-risk devices (such as tests for anti-HIV, anti-HCV, HBV, HDV, blood grouping) belong to Annex II A.

Annex II B includes other blood grouping tests, tests for Toxoplasma, rubella, CMV and Chlamydia antibodies, HLA tests, glucose self-testing, PSA tests, and tests for prenatal screening of trisomy 21 and phenylketonuria.
A third class (other devices, sometimes improperly called Annex III) includes all other diagnostic products.
Home (self) tests are regarded as critical products because they are intended for non-professional users. In fact a special conformity assessment procedure has been defined when they fall in the third category.

The device classification (Annex II A, II B and Other Devices) differentiates the route to conformity:
notified_bodies must certify quality system conformity of manufacturers of Annex II A and II B diagnostic products, by either undertaking an audit of the manufacturer’s full quality system (for Annex II A products this will also include a design dossier review and the assessment of conformity to “Common Technical Specifications”), or by carrying out type testing and production audit or sample examination. For products listed in Annex II A, the Notified Body shall also release each manufactured lot to be marketed. Annex II A, B and self test devices must show Notified Body’s identification number in association with the CE mark.
Self-tests will at least require examination by the Notified Body of the device design in terms of suitability for non-professional users.

Other devices can be CE marked upon manufacturer's self-declaration of conformity.

Besides devices already present on the market, special categories of products will be allowed without CE mark after December 7, 2003: Devices for performance evaluation(“For Investigational Use Only”), whose distribution will be allowed for external clinical testing of new devices to be subsequently CE marked and devices for research use only. The use of products from both categories is not intended to provide diagnostic information to patients.
Home brew tests will also be allowed, under strict responsibility of the laboratory which validates and uses them.

CE-marked IVD products must display more information, achieved by new labelling, standardized symbols, harmonized wording and instructions for use translated in local languages when required by local transpositions of the IVD Directive.

A Medical Vigilance system is prescribed as specific mechanism of market surveillance for CE-marked products. In accordance with it, manufacturers’ obligations are the following:
  • Systematic review of experience gained from devices on the market.
  • Implementation of appropriate means to apply corrective actions, as necessary.
  • Reporting of serious incidents, near-incidents and recalls to the Competent Authority.
  • Central recording and evaluation of incident (near incident or recall) reports by a National Competent Authority.
  • Establishing appropriate structures and procedures.
  • Informing manufacturers (or their representatives) of user reports.
  • If possible, assessment of cases that lead to corrective actions, together with the manufacturer, and immediate information to Commission and Member States.

Diasorin S.p.A, its Affiliates and industrial Partners are committed to achieve conformity to applicable essential requirements of IVD Directive, and want their Customers know they are striving to improve quality of their products and services.