Blog

IVDR & In Vitro Diagnostics


In Vitro Diagnostics Regulation (IVDR) Changes

 

Listen to this In Vitro Diagnostics highlight from RCA Radio where Seyed Khorashahi breaks down the EU’s move from list-based IVD device classifications to a rule-based IVDR medical device classification, resulting in four new device classes.
 
 

 

Listen to the entire episode where we go over all of the important things happening in the Medical Device industry here.

 

 

Device Classification Changes

  • List-based Classification to a Rule-Based 
    • Class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.
  • MDGC 202- 16 Guidance on Classification for in vitro diagnostic Medical Devices under Regulation (EU) 2017/746.

 

Lifecycle Approach

  • Establishment and Demonstration of effective Quality Management Systems (QMS).
  • More stringent requirements for clinical evidence that demonstrates conformity.
  • Post-Market Performance monitoring and reporting requirements.
  • Introduction of Unique Device Identifiers (UDIs) for improved traceability.

 

Supply Chain Oversight

  • Regulations covering the entire supply chain.
    • Economic Operators
      • Importers
      • Distributors
      • Authorized Representatives
  • Notified Bodies have discretionary authority to audit suppliers and subcontractors

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Connect with RCA Today

Contact us to learn more about our regulatory compliance experts and how they can help


    Footer artwork