Pre-market clinical evaluation consultation procedure: Update to MDCG guidance

The MDCG updated its Interpretation document on Article 54 (2)b of the MDR that exempts certain already marketed class III and class II devices from otherwise necessary clinical evaluation consultation procedure under Article 54(1).

Two pages were added to the document and require from the manufacturer to submit to the Notified Body with its application:

  • a statement that it has marketed the device in question for the same intended purpose under the relevant Directive,
  • copy of the last issued certificate(s) together with the certificate history, and
  • a description of the modifications introduced to comply with the MDR

In accordance with the MDCG, the Notified Body will:

  • verify that the “modifications”, as referred to in the main document, do not adversely affect the benefit-risk ratio. In particular, the notified body will verify:
    • that the device in question had a valid certificate under the Directives,
    • n case the certificate has been withdrawn, suspended or expired, if there is an impact on compliance with the general safety and performance requirements, and
    • that there is no pending assessment of changes for the device or outstanding non-compliance.
  • verify the description of modifications provided and assess if these modifications are limited only to those needed in order to comply with the new legal requirements introduced by the MDR. Limitations of the intended purpose of the device should not trigger the consultation procedure in accordance to Art. 54.

In case that these conditions are not fulfilled, Article 54 will fully apply and the Notified Body will follow the consultation procedure and include the expert panel. Full guidance is accessible here.

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