The clock is ticking – MedTech Europe’s recommendations ahead of May 2025 deadline for Class D IVDs
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening, and b) those related to management of life-threatening infectious diseases. Under the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (‘IVDR’), Class D devices rely on a complex infrastructure whose elements must work together: Common Specifications, Expert Panel assessment, Notified Body review, and evaluation by EU Reference Laboratories. MedTech Europe has always supported the full and early establishment of all needed infrastructure for Class D devices.
With the deadline to certify Class D devices under the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (‘IVDR’), arriving in only 18 months from now (26 May 2025), manufacturers wishing to transition their devices face numerous challenges in the
- With this paper, MedTech Europe makes several recommendations to ensure the continuous supply of Class D devices from the transition date of 26 May 2025.
Several European Ministers of Health at the EPSCO Council meeting of 30 November 2023, called for measures – including extended transition time and a root cause analysis of the issues – to address potential shortages in Class D devices which are not transitioning to the IVDR. Any additional time given must be used by the European Commission, MDCG, Notified Bodies and other actors to identify blockages and improve the efficiency and predictability of the system – with the goal of enabling all manufacturers to transition their devices to IVDR.
- For devices which are today not (yet) covered by EU Reference Laboratories (EURL) – including during the EURLs transition period – Notified Bodies should strive to align their approaches for conformity assessment and batch release.
- For devices covered by EURLs, it is essential to plan for the inclusion of devices covered by EURLs during the transition period. Collaboration among authorities, EURLs, and stakeholders should be initiated now to ensure preparedness for mandatory activities under the In Vitro Diagnostic Regulation (‘IVDR’). The paper outlines proposals for efficiently establishing EURLs in this context. In that regard, several proposals are made in the paper for the efficient setting up of EURLs.
- Prior to the end of the transition period, the Joint Research Centre should assess each EURL if it is ready to carry out the necessary batch release and performance evaluation and will be operational by the deadline. This assessment will allow the Commission to use the provision of article 100(9) of the IVDR and pause or restrict the designation of an EURL where they are not ready. Considering that the publication of an Implementing Act for this purpose will take at least three months, it is recommended that the assessment takes place three months before the end of the transition. The Joint Research Centre could seek advice from Notified Bodies when conducting this assessment.
- Re-classification should be considered for devices intended for the detection of the presence of, or exposure to, SARS-CoV-2, given that their pathogenic presentation is comparable to other non-class D respiratory viruses and COVID-19 is no longer considered a pandemic or a generally life-threatening condition. Also see Annex I at the end of this paper.”
Read the full paper below.
Posted on 14.12.2023