New Update to the MDCG 2022-4 Guidance Document

The Medical Device Coordination Group (MDCG) has released an update to the MDCG 2022-4 (Rev. 2) guidance document. The guidance document has been updated to align with the recent amendments brought by 2023/607 to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This update ensures that the guidance is consistent with the latest regulatory changes. 

Key Changes and Dates for MDR and IVDR Compliance:

The updated guidance document now includes new dates for when certain medical devices can be placed on the market or put into service under specific conditions: 

• • 31 December 2027: Class III devices and Class IIb implantable devices (except for specific items like sutures and dental braces). 
  • 31 December 2028: Other Class IIb devices, Class IIa devices, and Class I devices that are sterile or have a measuring function. 

New Surveillance Requirements: 

• • From 26 September, Notified Bodies not certified under MDR must transfer surveillance responsibilities to the Notified Body with which the manufacturer has an MDR certification agreement for legacy devices. 

Written Agreements and PMS: 

• • Emphasizes the need for written agreements between manufacturers and Notified Bodies under MDR, especially if they differ from the ones that issued MDD or AIMDD certificates. 
  • Notified Bodies are now required to verify and document post-market surveillance (PMS) processes, plans, and reports in line with new MDR requirements. 

Audit Activities: 

• • Notified Bodies should focus on technical documentation assessments according to MDR. 
  • The entire Quality Management System (QMS) will be assessed as part of MDR conformity, with attention to any unmet conditions from Article 120(3c). 

Manufacturers of Legacy Devices: 

• • For those not transitioning to MDR, Notified Bodies should verify the application of principles from MDCG 2020-3 Rev. 1. 
  • Combined MDR and surveillance audits should be performed if they have similar scopes and manufacturing sites. 

For more detailed information, you can read the updated guidance document here. 

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