Browse English Issue Headlines - May 2013

EU consultation process for medical devices incorporating an ancillary medicinal substance

Medical devices that incorporate an ancillary medicinal substance to enhance the usefulness of a device are in common use (e.g. drug-eluting stents with anti-proliferatives to help prevent restenosis, catheters coated with antimicrobials to help prevent infection, devices with a surface in contact with blood being coated with heparin to prevent thrombosis). The purpose of this article by Janine Jamieson, Elizabeth Baker and Krishna Prasad of the UK MHRA is to explain in more detail about the consultation procedure, especially in relation to: why there is a requirement for consultation with a medicines Competent Authority; when dialogue with the medicines Competent Authority could most usefully be initiated and when the consultation should be submitted; where the consultation can be undertaken; how the consultation process works; and what is required in terms of justification for inclusion of the medicinal substance and data to support quality, safety and usefulness of the substance. In addition, suggestions are made regarding areas where the MEDDEV guidance could be supplemented to clarify when consultations are necessary and what additional measures could be implemented for these combination products to encourage better communication between stakeholders (manufacturers, Notified Bodies, Competent Authorities and users) thus ensuring better protection of public health. More >>

Industry’s view on the current regulatory reforms in Australia

Over the last year, the Therapeutic Goods Administration (TGA) has implemented a range of regulatory reforms based primarily on the release of the TGA Transparency Review report, two Senate Committee reports on the regulation of higher risk medical devices and Poly Implant Prothčse breast implants, and the TGA Blueprint. On 1 July 2012, the anticipated changes to the regulation of hip, knee and shoulder joint replacements commenced with reclassification from Class IIb to Class III medical devices. Other proposed reforms have included: an increased rigour of pre-market regulatory assessment of higher risk medical devices; a requirement that sponsors nominate product names under each Australian Register of Therapeutic Goods entry for each kind of medical device; and an increased level of available medical device product information on the TGA website. Anne Trimmer from the Medical Technology Association of Australia examines Australia’s proposed regulatory reforms and their likely impact from an industry perspective. More >>

Industry’s view on the future of in vitro diagnostic (IVD) legislation in Europe

For the last 15 years, the European regulatory landscape for in vitro diagnostics (IVDs) has been shaped by Directive 98/79/EC. During this time, patients and laboratories within Europe have been able to access novel technologies with relative ease, while overall the safety record of IVDs in the European Union (EU) has remained excellent. However, although the overall record of IVDs has been positive under Directive 98/79/EC, the system has also revealed some significant shortcomings that need to be addressed. Jesús Rueda Rodríguez looks at the new Regulation for IVDs, which has been proposed as the replacement for Directive 98/79/EC, and provides an industry perspective on the impact of the proposed changes. More >>

The evolving regulation of medical device clinical trials in the USA

Clinical trials for medical devices are the subject of increasing interest by policymakers, including the US Food and Drug Administration and other US government agencies. This article by Erika F Lietzan and Emily A Alexander outlines recent changes related to the US regulation of clinical trials and highlights developments that are likely to occur during 2013. More >>

A critical examination of Commission Regulation (EU) No 722/2012 on medical devices utilising tissues of animal origin

The purpose of Commission Regulation (EU) No 722/2012 is the maintenance of a high level of safety and health protection against the risk from transmissible spongiform encephalopathies from medical devices manufactured utilising non-viable animal tissues or derivatives. The Regulation repeals Commission Directive 2003/32/EC and adds active implantable medical devices to the scope. Haroon Atchia summarises the important requirements of this Regulation, which will apply fully from 29 August 2013. More >>

European Update

  • Commission publishes recommendation on common framework for UDI
  • European Parliament issues draft report on proposed European medical device Regulation
  • European Parliament issues draft report on proposed European IVD Regulation
  • EESC issues opinion on proposed European medical device/IVD Regulations
  • Eucomed believes improvements are needed to device Regulation proposal
  • Manual on borderline and classification issues updated
  • Proposed amendments to the German device legislation
  • Sweden updates guidance on standalone software
  • Turkey issues notification on import controls for medical devices
  • Turkey drafts rules on electronic instructions for use
  • UK MHRA establishes a new web-based Innovation Office
  • UK consults on implementation of Regulations 722/2012 and 207/2012
  • UK’s NICE changes name and appoints new Chairman

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US Update

  • Additional safeguards introduced for children in clinical investigations
  • Wheelchair elevators and stair lifts exempt from 510(k) requirements
  • Reclassification of temporary mandibular condyle prostheses proposed
  • Class II classification proposed for scleral plugs
  • Comments sought on proposed Class II classification of eyelid weights
  • Proposed data requirements for clinical studies conducted outside the USA
  • Paediatric uses of devices: re-proposed amendment of regulations
  • Sorbent haemoperfusion devices; cranial electrotherapy stimulators; transilluminators
  • Pre-market approval requirement for automated external defibrillator systems
  • Use of standalone symbols to be permitted under new proposal
  • Guidance on Humanitarian Use Device designations finalised
  • User fees and refunds for PMAs, BLAs and 510(k)s: final guidance published
  • Final guidance on IVDs for detecting B. Burgdorferi antibodies
  • Clinical study design guidance for surgical ablation devices
  • Investigational Device Exemption (IDE) guidance for retinal prostheses
  • Final guidance on financial disclosure by clinical investigators
  • Guidance on 510(k)s for pulse oximeters finalised
  • Medical device classification product codes: how, when and why to use them
  • Draft guidance on third-party reviewer accreditation/re-accreditation process
  • Guidance drafted on distinguishing device recalls from product enhancements
  • ‘Latex free’ labelling to be replaced under new draft guidance
  • Additional requirements for glass syringes that conform to ISO 11040-4
  • Molecular diagnostic instruments with combined functions: draft guidance
  • Draft guidance on communications during device submission review process
  • Request for comments: effects of extreme weather conditions on medical devices
  • Technical amendments of the medical device regulations

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International

  • Argentina updates medical device regulations
  • Australia issues advice on reclassification of joint replacement implants
  • Important financial dates for sponsors of medical devices in Australia
  • Brazil introduces new GMP requirements for medical devices and IVDs
  • Canadian guidance on medical device licence renewals and associated fees
  • Guidance on classification of products at drug/device interface published by Health Canada
  • China replaces the SFDA and appoints a new Commissioner
  • China proposes special approval process for innovative devices and simplified re-registration provisions
  • China amends classification of IVDs and registration of re-packed IVDs
  • India releases guidance on the registration and importation of medical devices
  • IMDRF opens consultation on three new documents
  • Consultation held on Trans-Tasman early warning system on safety concerns
  • Japan relaxes device stability testing rules
  • Japan proposes to use third-party approvals for certain Class III devices
  • Malaysia accepts Conformity Assessment Body registration applications
  • Peru drafts new medical device classification regulation
  • Submission of CPR and LTO applications as e-copies in the Philippines
  • Saudi Arabia amends marketing authorisation system; timeframes; fees
  • Comments sought on draft Saudi guidance for grouping medical devices/IVDs
  • Guidance on change notifications for Class A and B devices issued in Singapore
  • Singapore consults on two risk classification guidance documents
  • South Korea Food and Drug Administration reorganises and changes name
  • South Korea reduces KGMP inspection requirements
  • Ukraine postpones implementation of Technical Regulations and adds to list of products subject to mandatory certification

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Standards Update

  • Canada proposes changes to list of recognised standards
  • China issues YY 0505-2012 for medical electrical equipment
  • Harmonised European standards
  • Kenya publishes draft standard for orthopaedic devices

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Reference Section

  • Regulatory personnel on the move
  • Country overview: Bosnia & Herzegovina

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