The Medical Device Coordination Group has published a joint implementation and preparedness plan for the incoming European Union In Vitro Diagnostic Regulation.
In the plan, MDCG, which advises the European Commission, admits IVDR implementation "remains a serious challenge," leading it to create the text to ensure the "limited resources" are focused on the activities that are critical to being ready by May 2022.
MDCG highlighted the risk of IVD shortages because of a lack of notified body capacity as a concern. In response, the group is proposing to make national experts available for the joint assessment of notified bodies and consider how conformity assessments can happen despite the pandemic.
The IVD industry has been sounding the alarm about preparations for incoming regulation for more than a year, in large part because of doubts about the likelihood of the small pool of notified bodies certifying all of the diagnostics that need to be assessed for the first time by May 2022. Despite a series of warnings by groups such as MedTech Europe, the Commission has so far stuck to its original timeline.
MDCG's plan acknowledges the industry concerns, stating that "the implementation of the IVDR has proven to be a very challenging task" and highlighting the availability of notified bodies as a notable worry. Part of the problem is MDCG and the Commission say they lack visibility into the situation.
"While it is clear that a greater capacity of notified bodies is needed under the IVDR compared to the IVDD, in the absence of information on the numbers of certifications needed, it is also not possible to predict what capacity of notified bodies will be sufficient to satisfy the demand," MDCG wrote. The group also said the Commission does not know "what proportion of manufacturers have already submitted their applications to a notified body and whether the capacity of notified bodies currently represents a bottleneck for them."
The Commission is performing a market monitoring exercise to gather data on the preparedness of the industry and to detect possible barriers that could create IVD shortages. MDCG said the data are key to understanding if notified body capacity is a bottleneck.
MDCG wants member states to help to grow the pool of IVDR notified bodies by making national experts available for joint assessments. The Commission and MDCG will also "consider how notified bodies can perform conformity assessment activities in COVID-19 circumstances," which could be a reference to the contentious topic of remote assessments. However, with MedTech Europe and other experts stating manufacturers already need to have filed for certification to ensure they are ready by May 2022, the actions may come too late to avert an IVD availability crisis in May.
The potential for crisis is reflected in the focus of the document on contingency planning. MDCG said it may monitor the availability of particular IVDs and "in exceptional circumstances and in the interest of public health or patient safety or health" communicate about "derogations from conformity assessment."
MDCG identified EU reference laboratories as the third area of essential action, alongside notified bodies and contingency planning. The laboratories will verify the performance of class D devices and play a particular role during the transition period, leading MDCG to state it is important to establish them as early as possible. As such, MDCG wants the Commission to adopt implementing tasks on the labs and to carry out a survey on the required capacity.
The second part of the MDCG plan focuses on high-priority actions "that are not essential to allow manufacturers to place devices on the market, but which would greatly facilitate the work of the involved actors." MDCG identified common specifications, guidance and standards as high-priority actions.