On May 5, 2017, the EU officially released the EU In Vitro Diagnostic Medical Device Regulation (IVDR). It came into effect on May 25, 2017, which marked the rise from the original Directive to Regulation at the regulatory level, which means that the EU authorities are paying more attention to the supervision of the medical device field.

In the IVDR regulations, the biggest change is the introduction of a risk-based classification method, which has undergone a fundamental change from the original IVDD. In the IVDD directive, in vitro diagnostic reagents and devices are mainly divided into four categories, namely List A, List B, Device for self-testing and Others. In IVDR, all in vitro diagnostic equipment is reduced from low to low based on product risk. High is divided into four categories: A (lowest risk), B, C, and D (highest risk). Along with the adjustment of product classification rules, it directly affects the conformity evaluation method of product listing.

Products classified as List A, List B, and Device for self-testing in the original IVDD instruction need to be reviewed by the notifying agency, while products classified as Others do not need to be reviewed by the notifying agency, and the manufacturer can declare itself. There are not many products classified as List A and List B in IVDD, and most of them belong to the classification of Others. In the IVDR regulations, only Class A non-sterile products can be self-declared by the manufacturer, but Class B, Class C and Class D all need to be reviewed by the notified body. IVDR has set a total of 7 classification rules in Appendix 8. Re-classification according to the new rules means that a large number of IVD products need to be certified by the notifying agency. For manufacturers that originally took the self-declaration path, it is likely to be in the new regulations. The following needs to be reviewed by the notified body. The main ways of conformity assessment under IVDR are as follows:

1. Class A

●Ordinary devices: prepare technical documents according to appendix Ⅱ + Ⅲ, and draft conformity declarations, not involving notifying agencies.

● Sterile instruments: Prepare technical documents according to Appendix II+III, and draft a conformity statement, and the establishment, assurance and maintenance of sterile conditions need to be reviewed by the notified body.

2. Type B

Prepare documents in accordance with Appendix Ⅸ, conduct quality system and supervision review, and obtain EU quality management system certification; conduct technical documentation and post-marketing technical documentation review, and obtain EU technical documentation assessment certification. If it is a self-tested device, user performance needs to be increased. ; Keep the documents as required by the competent authority of the country where the manufacturer or the EU authorized representative is located.

Three, C category

● Path 1: Prepare materials according to Appendix Ⅸ, conduct quality system and supervision audit, obtain EU quality management system certification, conduct technical documentation and post-marketing technical documentation review, and obtain EU technical documentation assessment certification, according to the country where the manufacturer or the EU authorized representative is located The competent authority requires the preservation of documents.

● Path 2: Carry out type test in accordance with Appendix Ⅹ and obtain EU type examination certificate; carry out quality assurance in accordance with Appendix Ⅺ and obtain EU quality assurance certificate; save the documents as required by the competent authority of the country where the manufacturer or the EU authorized representative is located.

4. Type C self-test or companion diagnosis

●If it is carried out according to Type C route 1, self-test products need to increase user performance. Companion diagnostic products need to consult CA or EMA before issuing a technical document review certificate.

●If it is carried out according to Type C route 2, there is no additional requirement for self-test products, but companion diagnostic products need to be issued with EU type inspection certificates, and the notified body should consult CA or EMA.

Five, class D

● Path 1: Prepare documents according to Appendix Ⅸ, conduct quality system and supervision review, and obtain EU quality management system certification; conduct technical documentation and post-marketing technical documentation review, and obtain EU technical documentation assessment certification; before issuing the certificate, the notifying agency should request EU The reference laboratory verifies the manufacturer’s declared performance and its compliance with CS, and keeps the documents as required by the competent authority of the country where the manufacturer or the EU’s authorized representative is located.

● Path 2: Carry out type test according to Appendix Ⅹ. The notified body should request the EU reference laboratory to verify the manufacturer’s declared performance and its compliance with CS. The manufacturer obtains the EU type examination certificate; carries out quality assurance according to Appendix Ⅺ and obtains EU quality assurance certificate; keep the documents as required by the competent authority of the country where the manufacturer or the EU authorized representative is located.

6. Class D self-test or companion diagnosis

●If it is carried out according to Category D route 1, self-test products need to increase user performance. Companion diagnostic products need to consult CA or EMA before issuing a technical document review certificate.

●If it is carried out according to Type C route 2, there is no additional requirement for self-test products, but companion diagnostic products need to be issued with EU type inspection certificates, and the notified body should consult CA or EMA.