Clinical Evaluations and the EU Market
Clinical evaluation is arguably one of the most important topics in the international medical device arena and the EU is no exception. As the EU regulations continue to be rolled out, albeit with a sliding timeline, industry and notified bodies are focusing on the interpretation and implementation of clinical information as it supports the end goal […]
FDA Third Party Review Programs
In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was […]
The MHRA Roadmap: Navigating the UK Market
While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extending deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines. Under this transition: Additionally, self-declared CE-marked […]
Clinical Evaluation – Single-Use Overtube
CHALLENGE: In March 2022, our client sought EU MDR 2017/745 compliance and CE-marking for their single use overtube. The product was intended to be used with an endoscope for intubation, changing endoscopes, and/or treatment in the gastrointestinal tract in adults. Clinical evaluation planning and reporting was an area where support was needed. Navigating the EU […]
Medical Device Single Audit Program (MDSAP)
A link to information pertaining to MDSAP and associated documents.
Guidance – MDCG Endorsed Documents and Other Guidance
This page provides a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonized implementation of the legislation.
FDA Announces the Issuance of Final Rule Amending the Quality System Regulation
Today, the resounding echo of the starting gun reverberates globally, signaling the commencement of a pivotal two-year transition period for device manufacturers and importers. This period marks the urgent need for them to adapt and enhance their quality management systems in alignment with the requirements of the Quality Management System Regulation (QMSR). The long-awaited final rule, issued by the FDA, has been a focal point of anticipation within the medical industry. The call for harmonization between ISO 13485 and the Quality System Regulations (QSRs) has persisted for decades, gaining heightened significance since its formal announcement in 2018 and the subsequent release of the proposed rule in February 2022.
EU Commission proposes another extension for IVDR transition
On January 23rd, amid concerns that there is not enough time for manufacturers to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EU Commission announced another proposal to extend the transition period. Previously extended at the end of 2021, this is the second time the Commission will look to provide additional time […]
FDA ESTABLISHES A NEW DIGITAL HEALTH ADVISORY COMMITTEE
The world of technology is moving at lighting speed. We are experiencing advances in software capabilities, interactions with automated services, and a far greater emphasis on how we are becoming more reliant on digital processes in our everyday lives. Case in point, when was the last time you were able to actually talk to a […]
FDA UPDATE: FINAL GUIDANCE SUBMISSION AND REVIEW OF STERILITY INFORMATION IN PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR DEVICES LABELED AS STERILE
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile”. Within the document, the FDA announces that it has recategorized vaporized hydrogen peroxide (VHP) to be an Established Category A sterilization process. As such, this places VHP in the same […]
