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Journal of Medical Device Regulation Issue Headlines - August 2011

Understanding the FDA’s Custom Device Exemption - Practical Solutions for Handling the Sale of Patient-Specific Devices in the USA

With the ever-increasing sophistication of medical technologies, patients and physicians alike are looking for more personalised solutions for addressing medical problems. In the face of this market demand for personalised medicine, medical device companies are increasingly seeking to manufacture and market devices that are tailored to address a specific patient’s needs. This is particularly true in the world of implantable reconstructive and orthopaedic devices, where physicians and patients are seeking implants that are tailor-made to match each patient’s anatomy. The trend toward personalised medicine, including personalised medical devices, has created new challenges for both regulators and manufacturers. This article by Danielle Woodlee seeks to remind device manufacturers of the FDA’s definition of custom devices, and the Agency’s interpretation of that regulation; to help manufacturers recognise what a custom device is, and what it is not; and to set forth recommendations for avoiding common custom device pitfalls and FDA enforcement actions. More >>

Controlling Microbial Contamination

Given the very complex nature of medical device production processes and the vast range of medical device types, it is hardly surprising that efforts are required to characterise and control the nature of microbial contamination. It is important to recognise that the microbial ecology of medical devices concerns not only the raw materials used but also the influence of the wider production process. In the widest context, this includes an appreciation of processes at the principal manufacturers, subcontracted operations and the quality of the total production environment. Haroon Atchia’s article examines the role of production microbial ecology in the quality of medical devices, providing an account of the nature of medical devices and an appraisal of factors influencing the composition of the microbial ecology. Factors influencing the characteristic contamination are discussed with a view to explaining the importance of correct methods in minimising and eliminating sources of contamination. The influence of regulatory obligations according to Directive 93/42/EEC and current convention are also examined. More >>

Risk Management for the Medical Device Industry in China

Risk management has become an essential element for pre-market approval and post-market surveillance in the USA and the European Union to ensure the safety and well-being of patients and operators when using medical devices. In China, there is an increasing awareness of risk management; however, its development is not of an organic nature. Issues that delay effective risk management taking place in China include the high level of tolerance of possible risks to patients and operators in using a device, medical negligence due to poor compliance to procedures, a shortage of trained risk management experts to execute the system and, above all, many manufacturers do not perceive themselves as having any liability after product launch. Unless all these issues are addressed, the medical device market in China will continue to embrace risk. It is in this light that Kally Wong examines the role of risk management in the Chinese medical device market. More >>

US FDA Releases Final Rule on Medical Device Data Systems - What Does this Mean for Device Manufacturers?

On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In addition, the authors will be discussing the challenges medical device manufacturers face in the changing regulatory environment. More >>

European Update

  • Denmark: Registration of clinical trials in Eudamed
  • Draft Commission Regulation on electronic instructions for use
  • Council rejects proposed amendments to IVD Directive
  • Council publishes conclusions on innovation in devices sector
  • Code of Conduct for European Notified Bodies: update
  • MRI’s exempt from new Electromagnetic Field Directive
  • A step closer to unitary patent protection in Europe
  • Court judgement: customs tariffs for plastic drainage bags
  • France proposes tighter controls for devices
  • France drafts guidance on medical device maintenance
  • Draft version of new German healthcare reform released
  • Hungary merges administrative functions of healthcare organisations
  • New Competent Authority for medical devices in Iceland
  • Italy introduces new registration requirement for clinical trials
  • Swissmedic updates information on clinical investigations
  • UK to require bar codes on all NHS-purchased devices by 2014
  • UK Medical Device Alert on needle-free IV connectors

More >>

US Update

  • FDA funding to be cut by 11.5% in FY 2012
  • Reclassification of the topical oxygen chamber for extremities
  • Classification of wireless air-conduction hearing aids
  • Exception from general requirements for informed consent
  • Applicability of classification for human dura mater
  • Proposed classification of IVDs for Bacillus species detection
  • Updated CPG on surgeons’ and patient examination gloves
  • Proposed improvements for reprocessing medical devices
  • Guidance on assembling diagnostic x-ray equipment
  • Guidance on IVDs used to detect influenza viruses
  • Draft guidance on financial disclosure by clinical investigators
  • Draft guidance on RUO and IUO in vitro diagnostics
  • Draft guidances on drug/device classification and chemical action
  • Draft guidance on IVDs used to screen for C. trachomatis and N. gonorrhoeae
  • Draft guidance on IVDs for detecting MRSA
  • Draft guidance on in vitro companion diagnostic devices
  • Draft guidance on IDEs and PMAs for LGS device systems
  • Draft guidance on optimising medical device design
  • Draft guidance on whether a product involves nanotechnology
  • Draft Enforcement Policy for certain diagnostic and radiology devices
  • FDA unveils new global product safety and quality strategy
  • FDA inspections database now publicly available
  • Survey finds FDA predictability a major concern
  • Analysis of ‘Not Substantially Equivalent’ determinations

More >>

International Update

  • Australian TGA fees and charges for 2011/12
  • Brazil releases compendium of device legislation
  • Anvisa consults on establishment licences and grouping of materials
  • Brazil proposes two measures to improve safety of devices
  • Health Canada fails to meet regulatory obligations
  • Canadian guidance on device licence renewals and fees
  • Canadian guidance on reprocessing and sterilisation of reusable devices
  • Canadian guidance on the content of QMS audit reports
  • Health Canada issues draft guidance on supporting evidence
  • Ontario proposes amendment to Product Safety Regulation
  • China drafts requirements for medical device recalls
  • Hong Kong’s MDCO revises numerous guidances and forms
  • Hong Kong publishes FAQs on devices containing DEHP
  • India may still implement device regulation Bill
  • India’s CDSCO begins to inspect foreign manufacturing plants
  • Australia/New Zealand to resume work on joint regulatory scheme
  • Streamlined process for trans-Tasman patents
  • Co-operation agreement finalised between Brazil and Sweden
  • More industry associations sign up to ethical business practices
  • New study lists best practice principles for device procurement
  • Unique device identification: global update; industry concerns
  • GHTF draft guidance on reportable events during clinical trials
  • GHTF definitions and glossary of terms
  • Japan creates on-line registration application portal
  • Mexico announces plans for improving device/IVD regulation
  • Saudi Arabia updates rules for licensing Authorised Representatives
  • Saudi Arabia requires appointment of local representatives
  • Singapore updates guidance on change notifications
  • Ukraine proposes abolition of Declaration of Conformity registration

More >>

Environment Update

  • Recast RoHS Directive applies to medical devices and IVDs

More >>

Standards Update

  • Ecuador drafts standard on latex condoms
  • Harmonised EU standards include phthalate labelling symbol
  • European standardisation is to be more comprehensive and faster
  • International standard for contact lenses updated
  • ISO conducts survey on revision of ISO 13485 and ISO/TR 14969
  • Korea proposes revision of biological evaluation standards
  • Saudi Arabia to adopt medical electrical equipment standards

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Mexico
  • Elemental Essentials: ISO 14155: 2011
  • A practical guide to the German ‘Medical Products Advertising Act’

More >>