IVDR: MDCG charts rollout in new implementation plan

The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) set to take effect next May.
 
With the date of application of the Medical Devices Regulation (MDR) now in the rear view, MDCG’s attention is turned to challenges on the horizon related to IVDR. MDCG previously released a joint implementation plan for MDR in March 2020, before the date of application of MDR was delayed by one year to May 2021. (RELATED: MDCG offers MDR implementation plan, ‘significant change’ guidance, Regulatory Focus 16 March 2020; MDR's Day One: Experts weigh in, Regulatory Focus 26 May 2021).
 
“Despite the efforts undertaken by all, the implementation of the IVDR remains a serious challenge. It has been compounded in 2020 by the additional efforts undertaken by all actors to respond to the COVID-19 pandemic. EU stakeholder organisations have reported that significant uncertainty hampers planning and preparation of their members for compliance with the IVDR. Nevertheless, ensuring patient access to safe and effective IVDs must be the focus of the implementation efforts,” MDCG writes, adding that it is the responsibility of all stakeholders to work together to ensure the legislation is operational by 26 May 2022.
 
Rather than necessitate a delay to IVDR, as some industry and patient groups have called for, MDCG says the COVID-19 pandemic “has further illustrated the need for a robust framework that ensures high standards of quality on the EU diagnostics market.” (RELATED: Industry and patient groups call for IVDR delay, Regulatory Focus 1 June 2021).
 
“As the date of application of the IVDR is approaching, the Member States and the Commission services are intensifying their work in coordinating activities, anticipating possible risks to device availability and taking appropriate measures,” the document states. “A special focus should be made for these discussions also at the level of the MDCG.”
 
These discussions should cover progress toward the transition from the current Directive to the IVDR, look at systemic risks to the availability of devices and consider steps to mitigate those risks. “To tackle these issues, the MDCG must engage in discussion more frequently than it has done so far,” the plan reads.
 
The plan also calls on actors and stakeholders to brace for uncertainty in areas where guidance is not available and ensure they have sound justifications for how they will satisfy related IVDR requirements.
In light of the disruption caused by the pandemic, the implementation plan calls for an analysis of IVDR under various hypothetical health crises occurring around May 2022 at a time when stakeholders will have little experience applying the new framework. The plan calls for the analysis to focus on “available emergency action tools, minimum timelines for conformity assessment of different kinds of devices, [and] potential bottleneck steps related to the Regulation,” such as the functionality of notified bodies, the supply of samples for EU reference materials and the elaboration of new common specifications.
 
The number of notified bodies designated under IVDR is also a concern, though MDCG says it cannot predict what capacity will be needed once the regulation goes live. “While it is clear that a greater capacity of notified bodies is needed under the IVDR compared to the [Directive 98/79/EC] 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 writes.
 
For diagnostics that required certificates under the Directive, those certificates will remain valid, under certain conditions, until May 2024, and, “Devices that were lawfully placed on the market under Directive 98/79/EC by virtue of a certificate may to continue to be made available on the market or put into service also after the date of application of the IVDR and until May 2025 at the latest under certain conditions.”
 
However, these transitional provisions only apply to IVDs placed on the market with a notified body certificate under the Directive. The manufacturers of the remaining products, which include some class D and most class C and B devices, must have undergone a conformity assessment procedure and assessment by a notified body by 26 May 2022 to continue marketing their diagnostics after the date of application.
 
“It is unknown to the Commission what proportion of manufacturers have already submitted their applications to a notified body and whether the capacity of notified bodies currently represents a bottleneck to them,” the document states.
 
Another critical area of concern is the designation of EU reference laboratories, which have not previously been established for IVDs and will be responsible for conducting testing to verify the performance of class D devices and their compliance with relevant common specifications. (RELATED: MDR/IVDR: Commission updates on implementation, notified body designation, Regulatory Focus 12 April 2021).
 
MDCG stresses that IVDR does not make reference lab testing of any class D diagnostics mandatory and that such requirements will not be applicable if no reference laboratories are designated for a particular device.
 
“However, during the transition period the situation is different. According to Article 110 (7), class D devices may be placed on the market according to the IVDR provided that the necessary appointments of the EU reference laboratories have been made. Therefore, if the appointment is considered necessary, their establishment as early as possible during the transition period is important to enable manufacturers to place IVDR-compliant devices on the market well on time before the date of application,” MDCG writes.
 
Several priority actions related to EU reference laboratories are detailed, including holding discussions with Member States, the Commission’s adoption of two implementing acts prescribed under Article 100(8) of the regulation and conducting a survey to assess the capacity needs for EU reference laboratories.
 
The implementation plan also details a set of high-priority actions that will greatly facilitate the rollout of IVDR but are not strictly necessary to allow manufacturers to place IVDs on the market. These include the adoption of common specifications; guidance for notified bodies on designation codes and batch testing; guidance on performance evaluations; the adoption of two implementing acts pertaining to harmonized European standards; and actions related to the oversight of companion diagnostics and in-house devices. (RELATED: MDR/IVDR: Commission adopts new standardization request, Regulatory Focus 16 April 2021).
 
MDCG