Journal of Medical Device Regulation Issue Headlines - November 2015

Guest Editorial: the Global Data Synchronization Network (GDSN) and medical devices in Canada

Around the world, the medical device industry and many leading healthcare providers have chosen the Global Data Synchronization Network (GDSN) and its GDSN-certified data pools as the systems of choice for the secure, accurate, global electronic communication of supply chain data. In Canada, conversations and implementation plans are beginning to take place in some provinces with regard to the utilisation of the GDSN-certified system for supply chain data management. However, Canada continues to lag behind the global momentum. In this article, Brian Lewis of MEDEC discusses possible reasons for Canada’s slow uptake and looks to the future for the Canadian medical device industry in seeking a GDSN-certified solution. More >>

Answers to frequently asked questions about the UDI requirements for medical devices in the USA

In September 2013, the US Food and Drug Administration (FDA) issued a final rule implementing the requirement that, with certain limited exceptions, the label and package of each medical device intended for distribution in the USA must bear a unique device identifier, or UDI. While the requirements of the UDI rule may have seemed difficult from an operational standpoint, it did not initially appear to be a rule that would be particularly difficult to interpret. This has not proven to be the case. Instead, what has become clear is that the wide variety of medical devices available in the USA may necessitate flexibility on the part of the FDA with respect to how the UDI rule is implemented. Whether the FDA will agree to such flexibility, and potentially different interpretations in application of the UDI rule, remains to be seen. Jennifer Newberger’s article reviews the background to the UDI rule, and addresses questions frequently raised by companies when considering application of the UDI regulation to their devices. More >>

Is EN ISO 14630:2012 a standard in need of improvement?

ISO 14630 is one of the oldest standards on non-active surgical implants but its origin is difficult to trace. Development of the standard was emergent and probably not according to defined principles or structure arising from scientific method. Evolution of the standard has been incremental rather than revolutionary, with relatively few edits over the years. In fact, until 2009, changes were unlikely to stimulate additional attention with respect to the design of non-active surgical implants. In 2012, four important design attributes were added to §5 of the standard. In 2015, the European Commission decided the 2012 edition was inadequate and could not afford presumed conformity so it was not harmonised, unlike its predecessor. It is curious that a standard considered suitable as a harmonised standard from 1997–2014, relatively stable in content and unaltered in scope, should lose favour with the European Commission. Did the edits to the standard in 2012 result in fundamental discord with the Essential Requirements and other relevant properties of Directive 93/42/EEC (as amended)? Or was it other reasons that led the European Commission to object to EN ISO 14630:2012? This article by Haroon Atchia explores in more detail one of the areas of the standard seemingly in need of improvement: the subject of design attributes, particularly relating to intended performance. More >>

Successfully outsourcing clinical investigations: the evolving role of Contract Research Organisations in device development

Clinical trial operations and research and development for pharmaceutical and medical device companies have become prime targets for outsourcing. An entire industry has developed to provide these services with explosive growth over the last 20 years and continued expansion in the foreseeable future. Dr Lynne Kelley’s article aims to explain the history, and project the future of, CROs; describe how to find and audit the right CRO; and offer advice on what to do when things go wrong. The article also provides some insight into how technology and social media are changing the clinical trial environment and the need for CROs to continue to evolve. More >>

European News

  • New organisational structure for the Danish Health and Medicines Authority
  • Trilogue negotiations start on new European Regulations on medical devices and IVDs
  • Manual on borderline and classification issues updated; clarification on software provided
  • MEDDEV 2.7/2 Rev 2 published to assist Competent Authorities when validating/assessing a clinical investigation application
  • France specifies conditions for marketing and distribution of devices sterilised using ethylene oxide
  • Germany’s BfArM publishes guide to help determine whether software apps are medical devices
  • Switzerland makes changes to medical device vigilance procedures

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North American News

  • Canada amends MDR with respect to non-corrective contact lenses and labelling of Class II devices
  • Comments solicited on draft Canadian guidance concerning licence applications for dermal fillers
  • Health Canada updates list of recognised standards for medical devices
  • FDA medical device user fees increase by over 4% for Fiscal Year 2016
  • US FDA increases export certificate fees
  • President Obama nominates Califf as next US FDA Commissioner
  • Key provisions relating to medical devices in the ‘21st Century Cures Act’
  • Coronary vascular physiologic simulation software devices now Class II (special controls)
  • Reclassification as Class II and renaming of shortwave diathermy devices for all other uses
  • Class II classification assigned to Clostridium difficile toxin gene amplification assay
  • External upper oesophageal sphincter compression device classified into Class II (special controls)
  • Class II classification for the oesophageal thermal regulation device
  • FDA classifies internal tissue markers into Class II (special controls)
  • Class II classification order issued for computerised cognitive assessment aids
  • Trichomonas vaginalis nucleic acid assay now a Class II medical device
  • Steerable cardiac ablation catheter remote control system: Class II classification
  • Class II classification assigned to the oral electronic vision aid
  • Classification/designation of paediatric beds, paediatric medical cribs and bassinets proposed by US FDA
  • Clarification drafted on when tobacco-based products should be regulated as drugs, devices or combination products
  • FDA revises recent guidance on the exemption of certain medical devices from pre-market notification
  • Guidance published on endotoxin testing recommendations for single-use intraocular ophthalmic devices
  • Recommendations issued for preparing and reviewing 510(k) submissions for nucleic acid-based HLA IVD test kits
  • Updated recommendations published on non-clinical testing of intravascular stents
  • FDA releases an updated acceptance review policy for 510(k) submissions
  • FDA publishes draft guidance on animal studies for medical devices
  • FDA offers advice on when a PMA supplement is required for a manufacturing site change
  • Guidance drafted on establishing performance characteristics for HPV IVDs
  • Candidates sought to participate in pilot programme for reporting device malfunctions
  • FDA unveils its top regulatory science priorities for 2016
  • FDA creates Patient Engagement Advisory Committee on medical devices
  • Vast amounts of new medical device-related data made public by the FDA on OpenFDA website
  • Modifications to the list of US FDA-recognised standards
  • New draft report makes recommendations for a National Medical Device Evaluation System
  • Guide drafted on securing Electronic Health Records on mobile devices
  • Stephen Ubl resigns as AdvaMed CEO

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Central & South American News

  • New Director of ANVISA takes office
  • ANVISA increases medical device registration and GMP certification fees
  • Certain medical devices may now share production facilities with pharmaceuticals in Brazil
  • ANVISA publishes new requirements for Class I and II medical devices and IVDs
  • Brazil publishes requirements for labelling of medical devices containing natural rubber latex
  • Brazil officially recognises Medical Device Single Audit Program
  • Brazil consults on requirements for implantable products used in permanent, artificial skin pigmentation
  • Technical standards required for INMETRO certification updated; IVDs exempt; compliance deadlines extended
  • Peru amends ‘Regulation on Registration, Control and Vigilance of Pharmaceuticals, Medical Devices and Health Products’

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Asia, Africa & Middle East News

  • AHWP releases draft guidance documents for public comment
  • China issues guidelines for medical device software registration and technical review
  • New advertising rules for medical devices take effect in China
  • China issues four guidelines on Good Manufacturing Practice for on-site inspections
  • India proposes expansion of notified devices’ list, as well as new QMS requirements
  • India to accept electronic clinical trial applications for medical devices and medicinal products
  • Japan has amended the precautionary text to be used in package inserts for electrosurgical devices and IOLs
  • Libya specifies requirements for registration of medical device and pharmaceutical manufacturers
  • Medical Device Authority in Malaysia now charges for Certificates of Free Sale/Manufacturing Certificates
  • Minor change to GDP regulation for medical devices proposed in Malaysia
  • Malaysia updates classification guidance for borderline products
  • New Zealand makes plans to regulate all therapeutic products, including medical devices
  • Saudi Arabia reduces medical device establishment fees for new applications and renewals
  • Saudi Arabia clarifies its rules for the advertising of medical devices
  • Singapore publishes draft guidance on grouping of medical devices for product registration
  • New medical device risk classification tool available in Singapore
  • South Africa consults on updated guideline for medical device and IVD product recalls
  • South Korea proposes changes to technical document approvals for veterinary medical devices

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Global Interest News

  • IMDRF to focus on supporting innovation and timely access to safe and effective medical devices
  • Numerous guidance documents finalised by the IMDRF
  • Updates to ISO 22442 on medical devices utilising animal tissues expected to be published in early 2016
  • ISO 9001:2015 published

More >>

Reference Information

  • Overview of the medical device regulatory requirements in Serbia

More >>