EFPIA fully supports the aim of the targeted revision for the MDR/IVDR to simplify and streamline the current regulatory framework. However, the proposal misses the opportunity to enhance the current system even further.

On the governance process, EFPIA supports a greater coordination role taken by the EMA as well as expansion of expert panels’ remits. The creation of a dispute resolution mechanism is also positive, as well as the increased clarity on regulatory status of devices. However, EFPIA believes that better EMA orchestration with the creation of a single-entry point for economic operators would ensure closer coordination between the medicines and medical devices/companion diagnostics’ pathways and secure consistent EU interpretation. This would reduce bureaucratic obstacles that hamper innovation and delay patients’ access.

Furthermore, EFPIA is asking to ensure that Notified Bodies (NBs) can work with EMA, NCAs and expert panels within the context of scientific advice procedures. This mechanism would guarantee early and accessible interactions between stakeholders to optimise the co-development of combined medicinal products and medical devices & IVDs.

Regarding IVDR Art 5.5, EFPIA strongly supports the proposed expansion of in-house test exemption to tests provided by central laboratories in the context of clinical trials. However, it is important to remove the requirement that they must be “established in the Union” since, for global trials, central laboratories providing innovative tests and novel technologies are often located outside of the EU. Having the flexibility to access these laboratories outside the EU for testing when clinical trials are happening in Europe would increase EU attractiveness for research and ensure patient access to life saving clinical trials.

EFPIA is also asking to set up a risk-based approach for medical devices, including medical device software, and IVDs used in combined studies that would ensure proportionate requirements. Devices that are not the primary object of evaluation or present only minimal clinical risks to patients should not require a Clinical Investigation Application or a Performance Study Application. The risk should be determined by the applicant in the context of use and notified within the Clinical Trial Application on a study-by-study basis.

EFPIA fully supports the coordinated assessment for clinical investigations and performance studies. However, EFPIA asks for implementing such coordinated assessment 6 months after the relevant functionality of the database EUDAMED is considered ready, and not 5 years as currently proposed by the Commission.

EFPIA welcomes the proposal for accelerated pathways, as well as NB’s prioritisation and rolling review to reduce their assessment timeline. However, the definition of Orphan IVDs should be improved and based on the EU Regulation 141/2000 on orphan medicinal products (<5 in 10.000 persons) and include populations with rare biomarkers.

EFPIA recommends the deletion of MDR Art 117 as it duplicates the related articles in the new pharmaceutical legislation. This deletion would permit the EMA to oversee end-to-end review and lifecycle management for integral Drug Device Combination products (iDDC). Furthermore, it should be clarified that only Annex I applies to iDDC. A risk-based approach should also apply to NB’s Opinions for medical devices when they have an established precedent. The EC proposal should also align risk classification for medical device software under Rule 11 with the International IMDRF risk categorisation framework, to reduce unnecessary regulatory burden.

Lastly, EFPIA strongly supports the Commission’s proposal (move MDR/IVDR to AI Act Section I.B) to remove legal and regulatory overlaps between the AI Act and the MDR/IVDR regimes.

Read the full feedback here.