Browse English Issue Headlines - May 2017

A critical examination of the fourth revision of MEDDEV 2.7/1, the European guideline on clinical evaluations

In June 2016, the revised European guideline MEDDEV 2.7/1 revision 4 was published. It became effective immediately, leaving no time for manufacturers or Notified Bodies to prepare for the changes. The lack of a transition period also left no time for Notified Body coordination, which in turn led to different expectations of Notified Bodies in terms of implementation. In many cases, the European MEDDEV documents are established guidelines that help manufacturers to understand and implement the requirements of the European Medical Devices Directives. In particular, MEDDEV 2.7/1 has turned out to be the gold standard as well as the prime working aid in the field of clinical evaluation for more than a decade. The previous 2009 version made an attempt to streamline European recommendations with those of the former Global Harmonization Task Force in order to achieve international harmonisation. The new version brings further clarifications on the ‘how to’. However, it focuses much more on European legislation, and anticipates requirements of the upcoming Medical Devices Regulation, due to be published in May 2017. This article examines the changes made by the fourth revision, which focus on increased and more specific requirements for the qualification of evaluators, more specific criteria for evaluation of equivalence, the obligatory search for Europe-related data, and clearer recommendations on update frequency. More >>

The regulation of DEHP in medical devices: continued use or restrictions?

Di (2-ethylhexyl) phthalate (DEHP) is a plasticiser largely used in medical devices for its excellent flexibility properties. In particular, DEHP is incorporated into tubing, bags and catheters, which are often installed in larger electronic medical devices (e.g. medical imaging devices). However, recent studies have highlighted a possible link between leaching of the compound into solutions, such as blood or nutrition formulas, and birth defects and infertility in animals. With that in mind, the European Union recently amended its legislation in a way that the use of DEHP in medical devices could be virtually banned in the coming years. In particular, the use of DEHP in medical devices may be severely restricted under product-specific vertical Union legislation (i.e. the forthcoming Medical Devices Regulation and Directive 2011/65/EU for the restriction of hazardous substances) and horizontal legislation on chemicals (i.e. Regulation (EC) No 1907/2006). However, while parts of these legislative amendments require implementing measures, other amendments foresee a number of exemptions from their scope of application. This article focuses on (i) an assessment of such legislative amendments, (ii) their interplay and (iii) how manufacturers of medical devices can participate in the on-going legislative process to provide their opinion and/or seek an exemption under the already adopted legislative amendments. More >>

Reducing uncertainty in medical device development: How the US FDA’s guidance on adaptive design for clinical studies can help

Adaptive design is a powerful and flexible approach for reducing uncertainty earlier in clinical studies. By allowing pre-planned, mid-study protocol modifications based on accumulating evidence (e.g. adjusting sample size or closing unsuccessful study arms), adaptive design studies can often reduce waste and identify promising trials quicker than with conventional design studies. Recent guidance from the US Food and Drug Administration (FDA) on applying adaptive design in medical device development helps reduce regulatory uncertainties and minimises risk for patients enrolled in studies by reducing their exposure to ineffective or unproven treatments. This article looks at how the FDA’s 2016 guidance can help sponsors take advantage of adaptive design studies to both increase medical device development effectiveness and efficiency, and support regulatory approval. More >>

How will the new EU Medical Devices Regulation affect the reprocessing of single-use devices?

The reprocessing of single-use medical devices (SUDs) takes place worldwide, including, to varying levels, within European hospitals. Manufacturers, hospitals and commercial companies have historically been subject to different regulatory requirements but this will all change with the adoption of the comprehensive new European Union Medical Devices Regulation (MDR). When published, the MDR will put in place manufacturer requirements for entities that reprocess devices labelled by the original manufacturer as ‘single use’. While some of the Regulation’s requirements are complex and arguably even contradictory, experience demonstrates that regulation will provide an overt, legal and safe pathway for hospitals to acquire lower-cost and environmentally preferable reprocessed or re-manufactured devices. This article summarises the main requirements introduced by Article 17 of the adopted version of the MDR and the impact these requirements are likely to have on the reprocessing industry. More >>

Overview of Taiwan’s laws and regulations on medical devices

The manufacture, import, export, retail, wholesale and rental of medical devices in Taiwan is controlled by the Taiwan Food and Drug Administration. This article gives a concise overview of the essential laws and regulations governing medical devices and provides detailed information on the pre-market registration requirements for each product class. More >>

European News

  • Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations
  • Europe: Court of Justice delivers its judgment on PIP breast implants case
  • Europe: Proposed updates to Common Technical Specifications for certain IVDs
  • Europe: SCHEER issues preliminary Opinion on use of non-human primates in biomedical research, production and testing of products and devices
  • Finland: Markus Henriksson appointed to lead Valvira
  • France: New obligations for Class III and implantable medical device manufacturers
  • Ireland: Draft guide to Good Distribution Practice for medical devices and in vitro diagnostics
  • Switzerland: New restrictions proposed for elemental mercury and mercury compounds, including use in dental amalgam
  • UK: Significant fee increases introduced by MHRA to aid cost recovery
  • UK: MHRA updates guidance on the regulations affecting medical devices and how the Agency enforces them
  • UK: Virtual manufacturing replaces own brand labelling

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North American News

  • Canada: Medical device fees increased by 2% from 1 April 2017
  • Canada: Static magnets may not be promoted with medical claims
  • Canada: Updated guidance on ISO 13485 QMS certificates issued by Health Canada-recognised Registrars
  • Canada: Public release of clinical information contained in medical device applications
  • Canada: Consultation being held on HIV simple/rapid test kits
  • USA: Scott Gottlieb nominated to lead the FDA
  • USA: 2018 budget for the FDA could result in significant user fee increases
  • USA: Regulatory reforms being introduced by the Trump Administration
  • USA: Technical amendment to identification of manual gastroenterology-urology surgical instruments and accessories
  • USA: Class II classification for vibratory counter-stimulation devices
  • USA: High throughput genomic sequence analyser for clinical use classified into Class II
  • USA: Class II classification for the continuous glucose monitor secondary display
  • USA: Classification of tobacco-derived products as drugs, devices or combination products delayed over ‘intended uses’ concerns
  • USA: List of Class I devices that are now exempt from pre-market notification
  • USA: List of Class II devices proposed for exemption from pre-market notification
  • USA: Labellers of soft (hydrophilic) contact lenses granted further UDI compliance extension

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Central and South American News

  • Brazil: Medical device and IVD fee reductions formally take effect
  • Brazil: Appeal timeframes extended by ANVISA
  • Brazil: Mercury to be banned in health products, including for use in dentistry
  • Colombia: Regulatory changes for medical devices include stricter timeframes for assessment and automatic approval of modification applications
  • Colombia: Modifications to the registration requirements for IVD reagents
  • Ecuador: New rules published for medical device registration and control

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Asia, Africa and Middle East News

  • Australia: Therapeutic Goods Amendment (2016 Measures No 1) Bill 2016
  • Australia: Consultation held on future regulation of low risk products, including certain Class I medical devices
  • Australia: Guidance issued on clinical evidence for medical devices
  • China: Medical equipment inspection fees abolished
  • China: Revised rules for the supervision and management of medical device recalls took effect on 1 May 2017
  • China: Review timeframes could be reduced for certain submissions under new proposals
  • China: CFDA makes minor adjustments to classification rules for in vitro diagnostic reagents
  • China: Technical guidelines published on the security of medical device networks
  • China: New standard for medical device Quality Management Systems in force from 1 May 2017
  • India: Medical Devices Rules, 2017 are a first step towards full medical device regulation
  • India: Enforcement action to be taken against medical devices notified as drugs that fail to display Maximum Retail Price
  • Japan: Four new innovative devices able to receive support through Sakigake Designation
  • Korea: Medical device sales blocking system introduced to aid product recalls
  • Malaysia: Export-only devices exempt from conformity assessment and labelling requirements
  • Malaysia: New guidance issued on registration of combination products
  • Malaysia: Notification of exemption from registration for medical devices intended for clinical research or performance evaluation
  • Saudi Arabia: New guidance on importing medical devices, including IVDs, and non-medical IVDs for educational or non-clinical research purposes
  • Saudi Arabia: Requirements for importing distillation apparatus are specified in a new guidance document
  • South Africa: Licensing timeframes specified for manufacturers, wholesalers and distributors of medical devices and IVDs
  • Taiwan: Amendments proposed to annexes to Regulations for Governing the Management of Medical Devices
  • Vietnam: Registration now required for all imported medical devices

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Global Interest News

  • Revisions underway for ISO 14971:2007 and its companion technical report ISO/TR 24971:2013
  • IMDRF: New final and draft guidance documents published
  • Mr Sergio Mujica to lead ISO from July 2017

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