Today, 3rd September 2021, the European Commission announced an important update regarding the implementation of the In Vitro Diagnostic Medical Devices Regulation- 2017/746.
The expert panel on IVDs now accepts submissions from Notified Bodies concerning the Performance Consultation Procedure! This is particularly relevant for devices that will undergo an additional scrutiny as part of their conformity assessment procedure, e.g. review by an expert panel or/and test by EURL (EU reference laboratory) and will allow eventual issuance of relevant Certificates as per the MDCG Questions & Answers reported earlier this year on Oh! It looks like you do not have access to this page.
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