Responses of IVDD Enterprises

For manufacturers of IVD devices that neither the IVDD nor the IVDR require the participation of a Notified Body, compliance procedures should be completed as soon as possible in accordance with IVDR 2017/746. Procedures include:

1) Prepare technical documents in accordance with IVDR 2017/746;

2) Designate an authorized representative of the European Union;

3) Complete the IVDR 2017/746 device registration;

4) Publish DOC files;

5) Implement the post-market surveillance system in accordance with IVDR 2017/746.