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 MDlaw.
Q1: During the transition period, may notified bodies accept applications from manufacturers for certification of Class D IVDs, and issue the corresponding certificates, if the IVD expert panel is not yet operational?
Notified bodies may accept and begin the assessment of applications for Class D IVDs. However, the notified bodies may not issue the certificate before the expert panel is operational and, for devices that require consultation of the panel, before the panel has provided its views (see also Q2 and Q3).
Such scrutiny is mandatory for high risk IVDs (Class D) for which no Common Specifications exist and where it is the first certification for that specific type of device and there is no similar device on the market having the same intended purpose and based on similar technology. Check recent MDlaw post on MDCG Guidance when it comes to the meaning of the”first certification for that specific type of device”.
Article 48 (6) of the IVDR requires that a notified body should consult the expert panels on the performance evaluation report of the manufacturer. This will be additional to the laboratory testing of the performance claimed by the manufacturer and the compliance of the device by the EU reference laboratories, where designated in accordance with IVDR Article 100.
The expert panels were established by the Commission Implementing decision in September 2019 on the basis of the MDR Article 106 & IVDR Article 48(6) governing their tasks, the requirements of its members, etc. You can find more information on the expert panels by clicking on the following link and here.
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