NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents

Between September and October 2022, Team-NB published various position papers. One of them addresses class D devices and their conformity assessment in absence of EU Reference Laboratories. A second one, instead, concerns the time to implement guidance documents.

Team-NB is the European Association for Medical devices of Notified Bodies.

Class D measures in the absence of EURLs

The position paper “Class D measures in the absence of EU Reference Laboratories – Points to consider for Notified Body approach” aims at providing a framework for the verification process by Notified Bodies of class D IVD medical devices. Specifically, the paper refers to the assessment of class D IVDs in absence of EU Reference Laboratories (EURLs).

In the conformity assessment procedures of class D IVDs, the notified body should request one of the EU reference laboratories (EURLs), if designated by the European Commission, to carry out further testing. However, EURLs are not available yet. In this sense, the position paper gives an overview on measures to apply until a EURL is designated for the specific category of device.

Especially, as per the MDCG the Notified Body should have documented procedures for:

• verification process
• establishment of a test plan
• provision for the reaching of an agreement

This paper provides possible solutions on how to gain such evidence in post and pre market circumstances.

Position paper on time to implement guidance documents

The paper “on transitional period for implementation of MDCG guidances and best practice documents” aims at harmonising implementation and application of MDCG guidance documents.

In particular, the proposal of the NB association is to implement a uniform transitional period for implementing MDCG guidance documents within their quality management systems/operating processes. More specifically, the proposed timeline foresees taking up to:

• 4 months from publication date to complete a gap analysis
• 8 months from publication date for a full impact assessment and updates to QMS documents, IT systems, processes, etc.
• 12 months from publication date for roll-out of the changes including staff training

In conclusion, the paper suggests that this approach will help standardise the implementation of the MDCG documents. In addition, it will help regulatory authorities and manufacturers predicting possible changes.

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