Browse English Issue Headlines - May 2015

Guest Editorial: The de novo pathway – strategies and tactics to use and avoid

The de novo pathway was originally created by Congress in an attempt to decrease the regulatory burden placed on manufacturers by making it easier to bring low-risk devices to market. Unfortunately it had the opposite effect. It is only since Congress changed the law again in 2011 and simplified the de novo process that it has really become a viable option for manufacturers. Michael Drues takes a look at the history of the de novo then explains which technology areas are most applicable for the de novo, how the process can be used as part of a competitive regulatory strategy, and best practices to adopt. More >>

Guest Editorial: Are the costs associated with the application of basic or general standards proportionate to the risk of a medical device?

The rising costs associated with the application of certain basic or general standards are a major concern worldwide. One of these standards, IEC 60601-1, has presented one of the largest cost increases ever. The cost of adherence to the standard’s complex requirements, which include an integrated Risk Management System and require use of other standards for software and usability, can almost be likened to the cost of purchasing a new car in the USA. Grant Ramaley examines why using the standard is so expensive and what options are available for reducing the costs. More >>

21st Century Cures Act discussion draft: key provisions relating to medical devices

A discussion draft of the highly anticipated US legislation, the 21st Century Cures Act, was released on 27 January 2015. The Draft Act includes proposals that stem from the 21st Century Cures Initiative that was launched in April 2014 by House Energy and Commerce Committee Chairman Fred Upton and Representative Diana DeGette. The Draft Act contains five titles that are spread over almost 400 pages and includes provisions that would significantly affect the regulation of medical devices, pharmaceuticals and biological products. A white paper released in conjunction with the Draft Act states that the proposed legislative changes are intended to: incorporate patient perspectives into the regulatory process and help address their unmet medical needs; build the foundation for 21st century medicine; streamline clinical trials; support continued innovation in federal public health agencies; and modernise medical product regulation. This article summarises the key provisions relating to medical devices, presenting these provisions in the order of the titles in the Draft Act. More >>

Directive 93/42/EEC: examples of inadequately defined or undefined terms and proposed interpretations

Directive 93/42/EEC concerning medical devices enjoys ubiquitous use throughout the medical devices sector, by legislator, regulator, manufacturer and other economic operators alike and to a far lesser extent, users of medical devices and by the public at large. Various terms are defined in Article 2 of the Directive but not all terms that possess a special meaning and that are used in subsequent parts of the Directive are defined in Article 2. Additionally, several terms appear to be used interchangeably or synonymously while the meaning of others seems unclear or prone to misinterpretation. Further, some terms appear juxtaposed or contradict similar or identical terms in certain European standards. Haroon Atchia’s article examines selected terms in the Directive and, by way of example, selected terms in the European standard EN ISO 14630, Non-active surgical implants. General requirements, in an attempt to clarify the regulatory position. The logical relation between terms is explored and definitions are proposed for terms undefined by the Directive and EN ISO 14630. More >>

European News

  • Joint Nordic project established to allow smarter procurement of medical equipment by using HTAs
  • Croatia’s HALMED Registry Office now operates from one location only
  • New Czech medical device law took effect on 1 April 2015
  • Danish Health and Medicines Authority appoints new Director as part of modernisation plan
  • Danish medical industry association Chairman resigns
  • ECJ rules that where a medical device has a potential defect, all products of the same model may be classified as defective
  • Directive 2011/65/EU amended to allow use of mercury and lead in specific circumstances
  • SCENIHR Final Opinion on the safety of the use of bisphenol A in medical devices
  • New German medical device rules come into effect in October 2015
  • Ireland’s HPRA updates its guide to CFS applications for medical devices
  • New guidance published in Italy concerning clinical investigations of medical devices
  • Switzerland updates forms for medical device clinical trials
  • New MHRA Devices Online Registration System (DORS) now active
  • UK MHRA now only accepts electronic CFS applications and charges small administration fee
  • UK MHRA publishes adverse incident reporting guidances for numerous different device types
  • Electronic instructions for use Regulation explained in new UK guidance document
  • New leaflet from the UK MHRA explains purpose of a Field Safety Notice
  • Association of British Healthcare Industries (ABHI) appoints new Chairman

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North American News

  • Commercially reprocessed single-use medical devices must comply with Canada’s Medical Devices Regulations by 1 September 2016
  • Health Canada increased medical device fees by 2% from 1 April 2015
  • FDA to get new Commissioner, and Deputy Commissioner for Medical Products and Tobacco
  • PMAs to be required for future and currently-marketed automated external defibrillators (AEDs)
  • A urethral insert with a pump for bladder drainage is now classified into Class II (special controls)
  • US FDA classifies brain injury adjunctive EEG assessment aid into Class II (special controls)
  • US classifies powered exoskeleton into Class II and designates applicable special controls
  • Assisted reproduction embryo image assessment systems classified into Class II with designated special controls
  • Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites: Class II classification
  • eMDR regulation amended to rectify inadvertent removal of UDI System regulation changes
  • FDA no longer plans to enforce regulatory compliance for Medical Device Data Systems and two similar radiology device types
  • Correction issued to performance standard for ionising radiation-emitting products
  • FDA launches new programme to fast-track medical devices for unmet medical needs
  • Guidance issued by FDA on balancing pre- and post-market data collection for devices subject to a PMA
  • US tightens controls on reprocessing medical devices in healthcare settings
  • US publishes guidance on safety considerations for small-bore connectors intended for enteral use
  • US FDA releases initial thoughts on pre-market studies for MIGS devices in draft guidance
  • Procedures for meetings of the Medical Devices Advisory Committee: comments sought on draft guidance
  • Guidance drafted on clinical trial designs for devices that affect fungally-infected nails
  • Comments solicited on new US draft guidance concerning cGMP requirements for combination products
  • Q&A guidance drafted on use of electronic informed consent in clinical investigations
  • US guidance drafted on technical performance assessment of digital pathology WSI devices
  • Electronic labelling project to be piloted to increase the safety of home-use devices in the USA
  • Modifications to the list of US FDA-recognised standards
  • Feedback sought on AAMI draft white paper concerning post-market risk management of medical devices

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Central and South American News

  • Brazil publishes packaging/labelling criteria for dental bleaching agents that are medical devices
  • New regulation on conducting clinical trials of medical devices in Brazil published
  • Brazil consults on good practice requirements for diagnostic imaging services
  • Official standard for radioactive implants published in Mexico
  • Peru issues draft standard for clinical electrical thermometers with a maximum device

More >>

Asia, Africa and Middle East News

  • Australian TGA restructures and renames parts of its organisation
  • Definitions of hip, knee and shoulder joint replacement devices and related ancillary devices added to Australian legislation
  • China’s Food and Drug Administration proposes medical device user fees
  • China revises Good Manufacturing Practice (GMP) requirements for locally-manufactured medical devices
  • China’s FDA issues ‘Good Supply Practice for Medical Devices’
  • 90 new industry standards released by the China Food and Drug Administration
  • Use of Egyptian Standard for automated non-invasive sphygmomanometers to become mandatory
  • Use of Egyptian Standard ES 4609-5:2014 to become compulsory in June 2015
  • India proposes formal system for pre-submission meetings for medical device applications
  • India plans to introduce medical device vigilance system
  • Medical device registration in Malaysia becomes mandatory on 1 July 2015
  • Fast-track registration process introduced in Malaysia until the end of the transition period
  • Malaysia consults on draft guidances: requirements for installation, testing, commissioning and acceptance; distribution records; PMS audits
  • Pakistan introduces new rules for medical devices and in vitro diagnostics
  • New guidance on labelling requirements for medical devices released in Saudi Arabia
  • South Korea proposes changes to its medical device classifications
  • Requirements for approval, notification and review of medical devices to be amended in South Korea
  • Changes relating to GMP inspections proposed in South Korea
  • South Korea proposes changes to ‘Enforcement Rule of the Medical Device Act’

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Global Interest News

  • IMDRF’s current consultations and finalised documents

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Reference Section

  • An overview of the medical device regulatory requirements in Indonesia

More >>