Small Change - Hugh impact: MDR Corrigendum

The change No. 10 (of the english version) addressing the Annex IX may have a Hugh impact to application for new Class IIa and IIb medical device and  the efforts during review the technical documentation.

 

The previous text of Annex IX, Section 3.5, first paragraph:

"In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the second paragraph of

Section 2.3."

 

is to be replaced by:

 

"In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as specified in Section 4 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the third paragraph of Section 2.3.".

Consequences:

The Chapters 4.1 to 4.3 and 49.- 4.10 become mandatory for the Class IIa and IIb products as well.

 

This leads to the following additional activities:

 

  • According 4.1- The manufacturer needs to apply for each technical documentation review with the Notified body.
  • According 4.2 - The manufacturer has to provide the FULL Technical documentation according to the Annexes II and III of the MDR to the Notified Body for review.
  • According 4.3 - The Notified Body shall examine the application and may ask for further test or evidence to complete the review.
  • According 4.9 - The Notified Body will in addition to the clinical review prepare report on the technical documentation assessment AND the notified body shall issue an EU technical documentation assessment certificate.

The implementation needs to be further monitored....