Euro Roundup: EU updates MDR, IVDR to add obligations for companies facing supply problems

The EU has amended the medical device and in vitro diagnostic regulations (MDR/IVDR) to require manufacturers to tell authorities when they anticipate a supply disruption or plan to discontinue a product.

Under the revised legislation, manufacturers are obligated to share details of supply disruptions with the competent authority in the EU country where they are based. Manufacturers also need to tell economic operators, health institutions and healthcare professionals that they directly supply the affected device to.

The requirement kicks in when a manufacturer “anticipates an interruption or a discontinuation of the supply of a device and where it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of serious harm to patients or public health.” Outside of exceptional circumstances, manufacturers should give six months’ notice. The legislation requires manufacturers to tell the competent authority the reasons for the interruption or discontinuation.

Other sections of the updated legislation are intended to facilitate the gradual rollout of Eudamed as it is finalized, instead of deferring the mandatory use of the device database until the last of the six modules is completed. The change is intended to accelerate the use of a delayed system to improve transparency and enhance the monitoring of device availability.

European politicians implemented the obligations and Eudamed revisions as part of legislative changes that extended the IVDR transition period. The Commission plans to answer questions about the shortage reporting requirements and Eudamed in upcoming publications.

This week, the Commission began the process of helping companies interpret the legislation by sharing a Q&A on the practical aspects of implementing the extended transition IVDR period. The text answers questions on the scope of the IVDR extension, the conditions companies need to meet to benefit from the flexibility and the surveillance that notified bodies should perform.

In one section, the Commission outlines the elements that manufacturers should include in their formal applications. In principle, a submission should include the elements listed in the conformity assessment, the Commission said, but “it needs to be taken into account that a full review of the application prior to the conclusion of the written agreement is not required.”

The Commission updated another Q&A about the extension of the MDR transition period. Version two of the document features one new question, the answer to which clarified that in principle manufacturers should address all aspects of the quality management system listed in MDR to meet the conditions of the extension. In practice, the Commission said manufacturers of some devices do not need to identify all general safety and performance requirements or put risk management in place.

As well as adding a new question, the Commission updated existing sections of the Q&A. The updated information includes a new explanation of when a manufacturer should submit a formal application. The Commission said submissions “should provide sufficient time for completing the conformity assessment procedure by notified body and manufacturer before the end of the transitional period.”

“Agreed timelines should be respected by both parties; delays and 'waiting until the last minute' should be avoided to prevent further bottlenecks in the certification process towards the end of the respective transitional period,” the Commission said.

Updated Regulation, IVDR Q&A, MDR Q&A

Groups warn joint clinical assessments will impede access to cell and gene therapies

More than 30 organizations have warned the EU’s implementation of joint clinical assessments (JCAs) will create a new barrier that prevents patients from accessing cell and gene therapies.

The Coordination Group on Health Technology Assessment (HTA) adopted a JCA methodology in March. In the document, the group said “it may well be necessary to deem that [single-arm or non-randomized evidence] is insufficient for estimation of the relative treatment effectiveness in the context of JCA.” The position is potentially a problem for advanced therapies that target rare diseases.

In a request for a rethink of the JCA methodology, the Alliance for Regenerative Medicine (ARM) and 31 other groups said it can be infeasible or unethical to study advanced therapies in randomized clinical trials because of factors such as the small patient populations and the need to treat people as soon as possible.

The groups believe their position is supported by the HTA Regulation, which they said “explicitly calls for the consideration of observational trials, real-world evidence and other sources of data beyond RCTs.” The call to action specifies what ARM and its cosignatories want to see happen.

“Scientifically robust methodologies exist that allow HTA to accommodate the type of clinical evidence generated for ATMPs,” the groups said. “Real-world data, including data from well-designed patient registries, retrospective and prospective observational studies, can and should be used to provide context and comparison for single-arm trials on questions such as natural history of disease.”

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EMA shares advice on requesting ‘OPEN’ review, sets stage for expanded program

The European Medicines Agency (EMA) has shared advice on how companies can ask for applications to be reviewed under the OPEN framework it has set up with global partners.

EMA began piloting the framework late in 2020 to support collaboration and expertise sharing related to COVID-19 vaccines and therapeutics. The agency has since expanded the framework to cover additional regulatory partners and therapeutic areas. EMA updated its Q&A on the framework this week, adding a new question on how to access the framework.

Companies can ask to be part of OPEN if they submit an application to EMA and at least one partner agency in parallel. The dossiers must be aligned. EMA is asking applicants to specify that they want their applications reviewed under the OPEN framework in their pre-submission request forms. The agency may refuse to include a submission in the framework “on the grounds of overall workload.”

EMA also revised answers to questions about which committees are involved and which products will be assessed. Previously, the agency said the framework was restricted to the Emergency Task Force and the Committee for Medicinal Products for Human Use. The revised Q&A says the framework “may be extended to other scientific committees and working parties.”

EMA Q&A

ABPI pushes new UK government to quickly pass clinical trials legislation

UK trade group ABPI has given a wish list to the newly elected Labour government, calling on the party to take actions including the passing of clinical trials legislation in its first 100 days in office.

Labour won a large majority to take power for the first time since 2010. Days after the election, the new secretary of state for health and social care said the healthcare system can drive economic growth. The plan, which echoes proposals made by the previous government, is to marry the healthcare system with the life sciences industry.

ABPI welcomed the high-level proposal and asked the government to quickly take a series of actions. The requested actions include the “urgent appointment of a new chair and chief executive to the Medicines and Healthcare products Regulatory Agency.” The request to pass the clinical trial legislation reflects the belief it will make the UK a more attractive location for inward investment.

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Euro Roundup: EU updates MDR, IVDR to add obligations for companies facing supply problems

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