UK medical devices law reforms delayed till 2024

“The regulator said it was “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024” to ensure the new system of regulation is ready in time and to minimize the risk of supply disruptions for UK patients. The delay means manufacturers whose medical devices have a ‘CE’ marking, which certifies their compliance with EU medical device regulations, will be able to continue placing their devices on the Great Britain market up until 30 June 2024, not 30 June 2023 as previously indicated by the UK government.”

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FDA finalizes guidances on device post-approval studies, post market surveillance

“The US Food and Drug Administration (FDA) on 7 October released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket surveillance requirements and to better understand the agency’s expectations for conducting post-approval studies of these products.The final versions contain minor changes from the draft versions released for comment in May 2021. “These guidance documents are intended to facilitate and set expectations for timely initiation and completion of certain studies fulfilling postmarket surveillance requirements and of Post-Approval Studies (PAS), respectively.”

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New EU data quality framework aims to align stakeholders

”The European Medicines Agency (EMA) on Monday published a data quality (DQ) framework intended to put stakeholders on the same page regarding data quality, as data has become more critical to regulating medical products. The joint Big Data Steering Group, created by EMA and the Heads of Medicines Agencies (HMA), has published a document titled, Data Quality Framework for EU medicines regulation. It lists definitions, principles and guidelines that stakeholders can apply to a wide range of data sources to characterize and assess data quality used for regulatory decision-making. EMA says that the progress in digitization and information technology, and the resulting plethora of data being generated in health care creates opportunities for regulators but also makes for an increasingly complex landscape for regulatory decision-making. ”

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FDA seeks feedback on plans to draft and finalize medical device guidance in 2023

“The FDA published 13 of the 23 guidance documents planned for 2022, with most, 10, coming from the A-list. Still, the lighter publishing schedule compared to last year, when the FDA proposed 10 draft guidance documents on its A-list, means most of the top priorities in 2023 are left over from 2022.In the coming fiscal year, the regulator plans to publish draft guidance on voluntary malfunction summary reporting, clinical considerations for medical device premarket submissions targeting opioid use disorder and select updates for guidance for the breakthrough devices program. All three proposals also featured on the FDA’s A-list for 2022. The only newly proposed draft guidance on the A-list covers an electronic submission template for de novo request submissions.”

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Experts Still Concerned About Exceptions Under DSCSA

“Throughout HDA’s Traceability Seminar in Washington D.C. today, experts expressed concerns over undecided exception management processes that could lead to pharmaceutical products in limbo and disrupted supply chains under the Drug Supply Chain Security Act (DSCSA). There are a number of ways that operations can go awry as saleable units, aggregated cases, and their associated data move through the supply chain. Often receiving top billing in industry conversations: “Product, no data” exceptions. As the name implies, this scenario occurs when a trading partner receives a product shipment without data. It may mean that the majority of the shipment and data match, and maybe a single case’s data is missing, or it could be a larger volume issue where an entire truckload (or more) arrives without corresponding data.”

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