Although the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) share a common purpose, they apply to different categories of products, with specific differences in the following aspects:

1. Scope of Application:

   • MDR is a regulation for medical devices: It applies to all medical devices not used for in vitro diagnostics, including surgical tools, medical equipment, implants, etc.
   • IVDR is a regulation for in vitro diagnostic medical devices: It specifically applies to in vitro diagnostic devices, such as reagent kits and equipment used for blood analysis.

2. Classification System:

   • MDR: Implements a new risk-based classification system, detailing medical devices into different levels more comprehensively.
   • IVDR: Introduces a new risk classification rule, which is a significant change for the in vitro diagnostic device industry, especially increasing the scrutiny requirements for high-risk IVD products.

3. Clinical Requirements:

   • MDR: Strengthens the requirements for clinical evidence, demanding manufacturers to conduct clinical assessments and trials for most medical devices.
   • IVDR: Also imposes stricter requirements for clinical evidence on in vitro diagnostic medical devices, requiring more data to support the product's performance claims.

4. Post-Market Surveillance:

   • MDR: Has more explicit requirements for post-market surveillance of medical devices, such as mandatory market surveillance plans and regular safety update reports.
   • IVDR: Also strengthens post-market monitoring for IVD products, requiring continuous performance evaluation and monitoring of products on the market.

5. Responsibilities of Economic Operators:

   • MDR/IVDR: Both regulations provide more detailed stipulations on the responsibilities of economic operators (manufacturers, authorized representatives, importers, and distributors), but IVDR has stricter requirements for all parties in the IVD product chain.

6. Database and Transparency:

   • MDR/IVDR: Both regulations require the registration of medical device information in the European Union Medical Device Database (EUDAMED) to enhance industry transparency.

Although these two regulations are similar in many regulatory principles, they differ in implementation details, applicable product types, and specific requirements, reflecting the European Union's regulatory strategy and approach to different types of medical devices.