Product classification and compliance process

According to the classification rules specified in Directive 98/79/EC, the COVID-19 diagnostic reagents used for professional testing are products other than those on List A and List B. Its CE compliance procedure is the declaration of conformity, including:

·  Preparation of technical documentation by the enterprise,

·  Signing of the declaration of conformity,

·  Appointment of an European Authorized Representative,

·  Completion of the registration with the competent authorities of the EU member states.

 Response to the post-market surveillance

1. Investigation from the competent authority

Usually the information that needs to be submitted for the investigation from the competent authority includes the followings:

1) Instructions for use in English;              

2) Instruction manual in Dutch (if any);              

3) Product performance characteristics;              

4) Analysis and diagnosis evaluation report (performance evaluation report);              

5) Risk analysis;              

6) Declaration of conformity;              

7) Clear pictures of the outer package (all sides) of the COVID-19 kit (that is, how you deliver these in vitro diagnostic reagents); 8) Clear pictures of the labels;               

9) Where applicable, an FSCA list applicable to the related products;

10) Update of the status of FSCA.

The time limit for submitting the documents is 3 working days. Therefore, it is very important to prepare complete technical documentation before signing the DoC and declaring to the EU competent authority for registration.

2. Customer inquiry and communication and complaint handling

As an European Authorized Representative, it is necessary to deal with all kinds of inquiries and communications from overseas customers and regulatory agencies. If the relevant agency is not familiar with the European regulations, or the ability of communication and coordination cannot meet the requirements of the inquirers, obstacles may be caused.

When there are customer complaints about products, it is necessary to guide overseas users to fill out the FSCA form at the first time, and to instruct the manufacturer to analyze the problem, take corresponding measures, and report to the regulatory agency.