The European Commission (EC) has proposed to extend the transition period for medical devices under the Medical Device Regulation (MDR), a proposal which must go through several more steps before full legal adoption.
ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality
The Medical Device Coordination Group (MDCG) has released a new position paper, which reviews the means by which Article 97 of the Medical Device Regulation (MDR) can be applied to devices that have not been certified under the MDR. The paper states that the decision on whether to allow a device to remain on the market is up to the competent authority (CA) of record for the device, and that the device manufacturer may have only a one-year grace period before it will have to obtain a new marketing authorization under the MDR.
Many expected the FDA pilot program for software precertification to be a potential solution to many of the problems with the agency’s regulation of software as a medical device (SaMD). Unfortunately, it appears the precertification pilot was less than successful in providing a new regulatory path forward.
Medical DevicesDecember 6, 2022
Medical Device Production Systems a Significant Regulatory Undertaking
The latest draft guidance from the International Medical Device Regulators Forum (IMDRF) indicates that verification and validation (V&V) of the medical device production system (MDPS) is a complex matter, as is the question of who assumes the regulatory responsibility for the maintenance and use of these systems.
The International Medical Device Regulators Forum has produced a final working draft for verification and validation (V&V) of a personalized medical device (PMD), a much-needed source of regulatory harmonization. The document also addresses V&V for the medical device production system (MDPS) that will be used to manufacture PMDs.
Most FDA final guidances offer little more than a modest rewrite of the draft, but the FDA’s final guidance for clinical decision support (CDS) software represents a significant revision of the draft version. The changes seen in the final guidance may alter the regulatory status of both existing and developmental products, and developers of CDS software may wish to reevaluate their products in light of this new guidance.
Medical DevicesSeptember 28, 2022
FDA Draft Guidance for Computer Software Assurance a Fresh Look at Risk
Thanks to an ongoing controversy over computer system validation (CSV) for non-device software, the FDA draft guidance for computer software assurance (CSA) might be one of the most widely anticipated drafts to come out of the agency in several years. The key point is that the FDA explicitly acknowledges that software used in production and compliance systems does not necessarily present a high degree of risk, a key concession for those who believe the standing approach to compliance is often a case of regulatory overkill.
PharmaSeptember 22, 2022
ICH Expands on Analytical Methods Validation in Draft – Q2 Update
The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.
Medical DevicesSeptember 13, 2022
FDA Releases ICH Draft Guidance for Drug Analytical Procedure Development
The FDA has posted a draft guidance for pharmaceutical analytical procedure development by the International Council for Harmonisation (ICH), which is accompanied by a draft guidance for validation of those analytical procedures. This Q14 analytical procedure development draft takes up the question of how analytical technologies can be managed as part of the production process lifecycle change management, and thus the overarching intent is to provide a set of principles that help to ensure that drug product quality remains high in a cost-effective manner.
The European Union has undertaken several measures to address the difficulty of implementing the Medical Device Regulation (MDR), but these grace periods are coming to an end. The EU’s Medical Device Coordination Group (MDCG) recently advised medical device manufacturers that time is running out to reapply for a CE mark for existing devices in a position paper that serves as a warning that stragglers may be left out in the transition.
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