ARTICLE SUMMARY:
In this week’s roundup: the EU Parliament supports the Medical Device Regulation compliance extension; Brazil preps for a new underlying device regulation; a Medicare advisory committee provides input on Coverage With Evidence Development (CED); China 2022 device approval growth; guidance on comparison diagnostic classification in Europe, and more from China, the US Justice Department, and FDA.
Top Pick: Parliament Passes MDR Bill
Extended transitions almost set:
Legislation to extend Medical Device Regulation (MDR) transition times for legacy devices and remove sell-off deadlines for devices and diagnostics passed its final political test February 16 with the vote in favor of the bill by the EU Parliament. The EU Council, Europe’s other legislative body, has already agreed to the package; the Council now just has to officially adopt the Parliament-based bill before it is published in the Official Journal of the EU, suggesting the reforms could take effect in the coming days or weeks. Device experts say the extensions are necessary to relax notified body bottlenecks, but questions remain, including the status of devices labeled with expired certificates that rely on the CE marks for access to non-EU markets.
Next Pick: New Brazil Framework
What we’re watching for:
A new underlying device regulation, RDC 751/2022, is set to take effect in Brazil March 1, consolidating and formalizing an array of updates that the regulatory agency ANVISA has initiated in recent years. The new framework is intended, in part, to further harmonize Brazil’s document requirements and risk classification rules with other countries in South America and worldwide. Most pressingly, starting March 1, companies will need to rely on updated documentation to support regulatory notifications, petitions, and other submissions. ANVISA posted links to the new materials, and a Q&A guide to the new rules, this week. The agency is also convening a webinar February 16 on 751/2022, which will replace a 2001 regulatory framework. Specific updates included in the reforms are new classification rules for software and nanomaterials, adoption of the IMDRF premarket submissions table-of-contents structure, and rules related to electronic instructions for use.
Tech Assessment Picks
CED chat and NICE draft:
MEDCAC meets. A CMS advisory committee largely affirmed the agency’s plans to update criteria for data collection under its Coverage With Evidence Development (CED) program during a February 13 and 14 meeting. Most members of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) expressed general support for the 19 new or revised CED study requirements proposed by the Agency for Healthcare Research and Quality, albeit with suggestions for wording or concept revisions.
CED is employed by CMS as a means to condition national coverage determination (NCD) policies on the collection of evidence, by requiring either clinical trials, registries, or other data-collection methods. The agency’s existing 13 CED criteria and the proposed 19 criteria consist of general statements defining expectations for participants, protocols, enrollment, and data reporting, among other CED study features. The proposed criteria introduce explicit requirements that CED studies reflect the “demographic and clinical diversity” of Medicare beneficiaries and that a schedule for meeting study milestones be established in advance, among other changes. Several device industry representatives presenting to MEDCAC, including from Medtronic and Boston Scientific, proposed that CMS establish more explicit procedures to determine, based on the evidence, when CED data collection can end, but those ideas were not entertained by the committee. There was also outright opposition to the CED program from several outside speakers and one committee member. They argued the framework restricts patient access to new treatments, citing in particular CMS’s 2022 CED NCD requiring Alzheimer’s disease monoclonal antibodies to be enrolled in a clinical trial for coverage.
CMS has been leveraging CEDs in coverage decisions since 2004, but it has said it plans to codify the framework as part of an upcoming Transitional Coverage for Emerging Technologies regulation. (See “Never the Twain Shall Meet? Medicare CED Meeting Precedes TCET Rule,” Market Pathways, February 8, 2023.) Separately, the agency says it will issue a draft guidance for public comment outlining any revisions to CED criteria it plans to pursue.
NICE gene test draft. The UK National Institute for Health and Care Excellence proposed to conditionally recommend adoption of the Genedrive MT-RNR1 ID kit to gauge the risk of newborns developing hearing loss from use of an antibiotic (gentamicin). Under the draft guidance, as part of NICE’s Early Value Assessment program, hospitals would have to collect evidence on how the test affects time to antibiotics, prescribing decisions, and also on the technical performance and accuracy of the test.
European Picks
More from the EU:
EU companion Dx clarity. European policymakers aim to clarify when an IVD qualifies as a companion diagnostic (CDx) in updates to an existing guidance document. In February 10 revisions to a guidance on IVD Regulation (IVDR) risk classification rules, the Medical Device Coordination Group (MDCG) added more explanation of assays that do not qualify as CDx—in particular, assays, including genotyping assays, that establish a dosage for a drug that is already prescribed. It also includes new descriptive details of CDx categories, adds new specific examples, and, notably, inserts a new flowchart to guide decision-making on whether an IVD is a CDx. The IVDR pulled CDx under EU diagnostic regulations for the first time, designating them as Class C (in a Class A through D system) and also requiring notified bodies to consult with EU or member state drug regulators before granting a certification. The first CDx gained an IVDR CE mark in December.
EU vigilance Q&A. Expectations for meeting vigilance requirements, in particular evaluating and reporting device “incidents”—including complaints and adverse events—appropriately are addressed in a Q&A-format guidance published by MDCG February 14.
China Picks
NMPA data and docs:
China approvals skyrocketed in 2022. The number of devices and IVDs that China’s National Medical Products Administration approved jumped 46% in 2022, well above any recent year, including pre-COVID-19. Devices getting through NMPA’s Innovative Device pathway also continued to accelerate, with 55 devices approved via the pathway last year, the most ever since it launched in 2014. For both the traditional and innovative approval route, “domestic” devices accounted for a lion’s share of the activity, underscoring the importance of companies taking steps to “localize” operations. For more 2022 China approval stats, see: Market Pathways Scorecard, China Edition, 2022.
NMPA posts new guidance site. China’s regulatory agency launched a new website (link in Simplified Chinese) this week cataloging its general and product-specific guidance documents. The site organizes the documents by device category and links each set of documents to relevant China technical standards and to descriptions of required clinical pathways for the targeted devices. The site also includes sections listing US FDA and EU product-specific guidance documents, both in original form and unofficial Chinese language translations.
More to Watch
Also on our radar:
DoJ withdraws healthcare safe harbors. The US Department of Justice withdrew three long-held “antitrust policy statements” related to enforcement in healthcare markets, stating they are “outdated.” The statements, generated in 1993, 1996, and 2011, respectively, address hospital mergers, joint ventures, joint purchasing arrangements, physician networks, and accountable care organizations. They offer “safety zones,” where the government states it would not challenge certain arrangements under antitrust laws. “Over the past three decades since this guidance was first released, the healthcare landscape has changed significantly,” DoJ noted. “As a result, the statements are overly permissive on certain subjects, such as information sharing, and no longer serve their intended purposes of providing encompassing guidance to the public on relevant healthcare competition issues in today’s environment.”
Studies in newborns. FDA published a draft guidance addressing possible neurologic, sensory and developmental evaluations studies in devices (as well as drugs and biologics) that can be used to support safety of products in neonates (defined as babies up to 27 days after the birth due date).
Dates to Remember
For your calendar:
February 28. Medicare Administrative Contractors (MACs) will convene a multi-jurisdictional Contractor Advisory Committee (CAC) meeting to hear input on remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) for non-implantable devices.
March 1. Brazil’s updated underlying device regulation RDC 751/2022 takes effect. (See “Next Picks,” above.)
