Currently, MDD was abolished in 2017 according to MDR 2017/745 through many changes and customer-oriented thoughts and MDR has been newly established.

The MDCG guideline has been constantly enacted regarding MDR so far, thus you must understand all new regulations before proceeding.

1. Major details

Reinforce risk control

A. Obligation of periodic safety information update report (PSUR) 

B. Reinforce requirements for Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) 

C. Participation of expert panelS in clinical evaluation review for Class IIb and Class III, except for certain devices

Establish EUDAMED, a database at European Union Level 

A. Register UDI, manufacturer and European agents, certification service and certificates, clinical trials, post-marketing vigilance, and follow-up information

※ Reinforce and continuously update technical document requirements

A. All design/development data required by EN ISO 13485 

B. Monitoring/inspection/test criteria and methods of manufacturing process (including SOP) 

C. List of all suppliers, products and services provided by each supplier and their certificates, supervision plan for major suppliers, and supply contract

※ Clinical trial requirements which represent European population for implantable and high-risk group 

For implantable devices or Class III devices, submit a clinical trial report with the established logic to represent the European population except for certain devices