BSI statement on conformity assessment for class D devices under the IVD Regulation June 2021

News: June 2021

BSI would like to draw your attention to an important update regarding notified body activity for Class D IVDs under the In Vitro Diagnostic Regulation (IVDR) EU 2017/746.

The Medical Devices Coordination Group have recently published guidance MDCG 2021-4 ‘Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 in April 2021’We strongly recommend you read this document.

Class D IVD regulatory requirements.

Due to the classification changes, some IVDs that were self-declared IVDs under the IVD Directive are class D under the IVDR. These devices are excluded from any grace period and therefore must be certified under the IVDR by Date of Application (DoA-26 May 2022) or be removed from the EU market.

The conformity assessment of class D devices requires a specific regulatory infrastructure that includes EU reference laboratories (EURLs), Common Specifications (CSs), and, if no CS are available, the first certification for that type of device must progress through an EU expert panel.

Team NB position

At the point of writing (June 2021), there are no EURL designated, and there has been a delay in establishing the EU expert panel. In addition, no CS’s are currently published. As such, BSI has considered the MDCG 2021-4 guidance and worked with other notified bodies to identify a practical solution for implementation and a way to provide an appropriate conformity assessment of these products according to the IVDR. We are a contributing member of Team NB and would ask you to read the joint position paper for this issue.

Highly virulent corona virus (e.g. SARS-CoV, MERS, SARS-CoV-2 (Covid-19))

We expect these devices to be up-classified from self-certified under the IVD Directive to Class D under the IVDR and will be affected by this change.

BSI Implementation of MDCG 2021-04 and the ongoing situation

Following the statement with Team NB, BSI has now created a working solution to implement the guidance. This will be a risk-based approach, considering the following:

  • status of the devices under the IVDD,
  • the expectation of a first adoption of CSs, and
  • if a device is not expected to have a CS,
  • the risk of certification without the involvement of EURLs.

We understand the enormity of this issue for our clients, and we will work with applicants individually around the impact on their submissions. We will continue to monitor the situation and provide regular updates as the situation progresses.