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IVDD instruction

On 27 October 1998, the European Commission formally adopted the directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD Directive) and published it in EU Gazette No. L331 of 7 December 1998. According to the content of the communique, eu member states must be finished before June 7, 2000, relevant laws and regulations needed to implement this instruction command set and announcement, since December 2003, all sold in eu member states in vitro diagnostic (IVD) medical devices shall be in accordance with the instructions to complete conformity assessment procedures, with CE mark, To be listed in the European Union.

CE certification procedure for IVD products

1. Determine whether the product is IVD;

2. Determine the classification of IVD products and select the way of conformity evaluation;

3. Establish and maintain quality management system;

4. Prepare CE technical documents;

5. choose the right announcement organization

IVDD instruction

CE certification procedure for IVD products

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