Journal of Medical Device Regulation Issue Headlines - August 2013

Regulation of mobile medical applications in the USA and the EU

Healthcare in the USA and the European Union (EU) is becoming increasingly digitised as patients and healthcare professionals turn to mobile applications (or ‘apps’, as they are commonly known) for a wide variety of medical uses. Apps analyse glucometer data, calculate drug dosages, and diagnose diseases, among many other functions. As is often the case, regulators have struggled to keep pace with this rapidly changing technology. Although it has long been recognised that software can meet the definition of a medical device, the explosion in the number and potential uses of these apps has placed stress on gaps and ambiguities in the regulatory frameworks. This article by Christopher Pruitt and Brian Kelly provides an overview of the regulatory frameworks for mobile medical apps in the USA and the EU, and explains the practical steps for bringing a regulated mobile medical app to market in these jurisdictions. More >>

Satisfactory quality: relation of claims expressed by a manufacturer relative to the position of key regulatory parties in negligence

Manufacturers placing medical devices on the market with the CE mark of conformity are more familiar with the provisions contained in the respective Directives on medical devices but mostly ignorant of, or fail to realise, other obligations concerning product liability, including satisfactory quality. The relation of claims expressed by a manufacturer, including the intended use, must be examined relative to the potential position of all economic operators, including the manufacturer and other key regulatory parties, in relation to product liability and negligence. Haroon Atchia’s article examines, by way of examples, the implications of insufficient or inadequate attention to product liability, including satisfactory quality of medical devices. Although the article focuses on English law, the guiding principles should be considered when placing a medical device on the market in any Member State. More >>

US 510(k) process: recent changes and their impact on the medical device industry

Getting a medical device cleared through the US pre-market notification (510(k)) process can be challenging for manufacturers, and one of the greatest challenges of the process is that it is constantly changing. Bhavesh Sheth discusses some of the many recent changes to the 510(k) process, as well as some of the proposed changes that may affect manufacturers in the near future. The likely impact of these changes on the medical device industry is also considered. More >>

European Update

  • Czech Republic’s medical device reform legislation presented to government
  • New rules for distributors and importers in Denmark
  • ENVI vote on new medical device and IVD regulations postponed
  • Manual on borderline and classification issues updated
  • EDMA, Eucomed, MedTech Europe: organisation changes and office relocation
  • France implements final ‘sunshine’ obligations
  • Mandatory notification of devices with devitalised human tissue in Switzerland
  • UK proposes tighter regulation of cosmetic interventions
  • UK to pilot new tracking system for high-risk medical devices

More >>

US Update

  • Bill to create Office of Wireless Health reintroduced to House
  • Ingestible event markers classified as Class II (special controls)
  • Proposed down-classification of certain ECP cardiovascular devices
  • Reclassification of certain microbiology devices into Class II proposed
  • Reclassification of certain intra-aortic balloon and control system devices proposed
  • Proposed down-classification of stair-climbing wheelchairs
  • Reclassification of implanted blood access devices proposed
  • Proposed upgrade of the classification of sunlamp products to Class II
  • Assay migration studies for IVDs: final guidance published
  • Final guidance on injectors intended for use with drugs and biologicals
  • CDRH appeals processes: final and draft guidance released
  • Guidance drafted on biological evaluation standard ISO 10993
  • Feedback sought on draft cybersecurity guidance
  • Device reporting for manufacturers: comments sought on draft guidance
  • FDA decisions for IDE clinical investigations: draft guidance
  • IDEs for early feasibility medical device clinical studies
  • FDA issues progress report on national system for post-market surveillance
  • MedWatcher mobile app for submitting voluntary incident reports
  • Public input sought on availability of masked and de-identified data
  • FDA wants new regulatory science sub-committee to be formed

More >>

International Update

  • TGA fees and charges revised for 2013–2014
  • Australia consults on IVDs: changes to pre-market assessment of devices; new-to-market risk communication scheme; advertising of therapeutic goods
  • Hip, knee and shoulder joint replacements: application fees now apply in Australia
  • Factsheet issued on Australia’s medical device reforms
  • TGA outlines how it manages its compliance function
  • Australian audits are now termed inspections
  • Creation of Database of Adverse Event Notifications in Australia
  • Brazil’s ANVISA sets institutional performance goals
  • Canada revises guidance on fees for device licence applications
  • China’s new Agency delegates responsibilities to provincial FDAs
  • China exempts eight medical devices from CCC mark certification
  • More Class II medical devices to be exempted from clinical trials in China
  • New process for requests for supplementary information in China
  • Cuba requires import/export authorisation for biological materials
  • India moves forward with plans for separate medical device regulations
  • IMDRF opens consultations on three new documents
  • IMDRF drafts Regulated Product Submission (RPS) table of contents
  • Australia and New Zealand create Joint Adverse Event Notifications System
  • Japan consults on amendment of Pharmaceutical Affairs Law
  • Malaysia now regulates medical devices
  • Malaysia issues updated Good Distribution Practice guide
  • New Zealand system for managing medical device adverse event reports
  • Russia extends deadline for obtaining new registration certificates
  • South Korea makes changes to its Medical Devices Act

More >>

Environment Update

  • Canada proposes changes to hazardous products regulations
  • Revised rules on classification, labelling and packaging of substances and mixtures in Europe
  • European industry association publishes guidance on RoHS 2

More >>

Standards Update

  • EN 980: 2008 inadvertently deleted from list of harmonised standards
  • Updated version of ISO standard for self-testing glucose monitoring systems
  • Israel revises standard on sterile, single-use syringes
  • Japan revises electromedical safety standard

More >>

Reference Information

  • Regulatory personnel on the move
  • Elemental essentials: regulation of combination products in the USA and the EU
  • Country overview: Norway

More >>