RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    European Commission updates on MDR, IVDR implementation timeline

    The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR , ...
  • Feature ArticlesFeature Articles

    New claims under EU MDR and EU IVDR

    This article discusses medical device promotional and advertising product claims under Article 7 of the European Union’s new Medical Devices Regulation ( EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) and examines how and when product claims are misleading or false as defined under the regulations. Introduction    Article 7 of the EU MD R 1 and EU IVDR 2 provide new claims regulations for medical devices. All of the requirements relate ...
  • Feature ArticlesFeature Articles

    EU IVDR changes regulatory landscape

    This article discusses new requirements for technical documentation, periodic safety reports, notified body changes, postmarket surveillance and vigilance, labeling and product traceability under the European Union’s new In Vitro Diagnostic Regulations (EU IVDR).   Introduction   Many regulatory changes are scheduled to come into effect in May 2022 as part of the new EU IVDR (2017/746.) 1 However, it likely that EU IVDR will come into effect a year later t...
  • Regulatory NewsRegulatory News

    IMDRF consultations focus on IVD classifications, regulatory assessors

    The International Medical Device Regulators Forum (IMDRF) recently released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduc assessments of Conformity Assessment Bodies (CABs). The 16-page proposed document on IVD classification is meant to help IVD manufacturers select an appropriate risk class using a set of harmonized classification principles and based on the device’s...
  • Regulatory NewsRegulatory News

    Hospitals report ‘severe shortages’ of COVID-19 tests, HHS survey finds

    The US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) on Monday released the results of telephone survey of 323 hospitals across 46 states, the District of Columbia and Puerto Rico, finding “severe shortages of testing supplies and extended waits for test results.”    Hospitals reported that they were unable to keep up with COVID-19 testing demands because they lacked complete kits and/or the individual components and supplies needed t...
  • Regulatory NewsRegulatory News

    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
  • Regulatory NewsRegulatory News

    FDA Classifies IVDs for Bacillus Detection

    In vitro diagnostic (IVD) devices for the detection of the Bacillus species were assigned to class II on Friday, following the release of a US Food and Drug Administration (FDA) final rule. The IVDs are prescription devices and indicated to aid in the diagnosis of diseases caused by the Bacillus species, including anthrax. They are intended for the detection and differentiation of the bacteria, such as Bacillus anthracis , and had been unclassified devices prior ...
  • Regulatory NewsRegulatory News

    MedTech Europe Urges Tailored Approach to Validating Biomarker Assays

    MedTech Europe issued a discussion paper to propose a fit-for-purpose approach for the validation of biomarker assays used in early clinical trials, offering three new guiding principles. The 8-page discussion paper takes issue with a trend among some competent authorities seeking to mandate CE marking on predictive biomarker assays prior to being used in clinical trials. It asserts that industry agrees with “overarching safety goals” that assays should be appropriately...
  • Regulatory NewsRegulatory News

    FDA, CMS, CDC Launch Task Force for Emergency Diagnostics

    Three US Department of Health and Human Services agencies announced Tuesday the launch of the Tri-Agency Task Force for Emergency Diagnostics (TTFED) to better respond to public health emergencies. With the distinct roles set for each of the agencies, TTFED is intended to leverage the expertise of the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) around the development...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Oncology Companion Diagnostics

    The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling. “We’re concerned that the situation is not optimal for patient care because a clinician may need to order a different companion diagnostic, obtain an additional biopsy from a patient or both, to have additional therapy treatment options,” US Food and Drug Administration (FDA) Commissioner Scott G...
  • Regulatory NewsRegulatory News

    FDA Offers Two New Draft Guidances on Developing Targeted Therapies

    The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address underlying genetic mutations that often cause or contribute to diseases, and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from a drug study. "New drugs are being developed based solely on their ability to target these und...
  • Regulatory NewsRegulatory News

    FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

    The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). Under CLIA, clinical laboratories must obtain a certificate to perform complex diagnostic t...