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Archive: Interpretation of IVD Directive

Implementation of the IVD Directive hold potential to boost sales opportunities in Europe

By harmonizing regulations throughout Europe, the In Vitro Diagnostics Directive (IVDD) will allow manufacturers to seize sales opportunities across the continent and may encourage those that have not previously exported.
The IVDD, which will introduce Europe-wide regulation for the IVD industry, could revitalize a stagnant market. Over the past five years, sales of IVDs in Europe have shown an average annual growth of only 1.1%. In 1998, the total market for IVD products was worth $6 million in the European Economic Area and Switzerland - less than 1% of healthcare expenditure.

The key elements of the directive, which will have a three-and-a-half year transition period when it comes into force next June, are classification, essential requirements, technical documentation, conformity assessment procedures and written declaration of conformity. Manufacturers of devices which need notified body services have been advised to be sure they are available. Under previous directives, the independent testing bodies were severely stretched in the last 12 to 16 months of the transition period.
Annex II List A and List B products (i. e. those perceived as being high-risk) will need notified body certification to show both design and production compliance with the IVDD.

In addition, List A IVDs will be subject to batch release testing. The design of self-test products must be certified by a notified body, while product conformity will be self-certified. Manufacturers of all other IVDs (i. e. those perceived as being low-risk) will self-declare for both design and production conformity.

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