Browse English Issue Headlines - May 2016

Guest Editorial: Certain dental and consumer groups in Europe voice concerns over proposals contained in new Medical Devices Regulation

Since 13 October 2015, consultations have been taking place between the European Council, the European Commission and the European Parliament on the revision of the Medical Devices Directive. A number of European dental and consumer organisations have publicly aired their concerns over the proposal for a new Medical Devices Regulation published by the European Council, believing that the safety of patients has not been made the top priority. These organisations feel that some of the proposed requirements should be strengthened by adding more details and, in some cases, making them mandatory. Topics of primary importance are device labelling, devices releasing nanomaterials or hazardous substances, use of implants with the least associated risk, market approval criteria for dental amalgam, and better monitoring of market authorisation. More >>

Implications of the EU Court of Appeal judgment on the PIP breast implant case

In a judgment from 2 July 2015, the Aix-en-Provence Court of Appeal declared null the judgment rendered by the Toulon Commercial Court on 14 November 2013, which had imposed joint and several liability on the German company TÜV Rheinland Product Safety GmbH and TÜV Rheinland France to make up for material and non-material damages caused to distributors and patients fitted with breast implants manufactured by Poly Implant Prothèse (PIP). After concluding that the TÜV companies had respected their legal and contractual obligations, the Court of Appeal dismissed the opposing parties’ claims, which had sought to establish the TÜV companies’ liability. This article summarises the main findings of the Court of Appeal, which it used in its decision to dismiss all claims formulated by the plaintiffs. More >>

Update on the regulatory situation for medical devices in the CIS region

The Commonwealth of Independent States (CIS) is a region with constant, and often quite radical, changes in medical device regulations. This article summarises the most significant new regulations in the largest CIS countries in order to provide a clearer picture of the regulatory requirements for medical devices in the region. The article also examines the new registration procedure for medical devices placed on the common market within the Eurasian Economic Union (EAEU) in accordance with the International Treaty within the EAEU. This Treaty defines the common principles and rules of circulation of medicinal products and medical devices. More >>

Medical device technical documentation: current and future requirements in Europe

Before a medical device is placed on the market in Europe, the manufacturer of that device must demonstrate that it has met the applicable Essential Requirements of the relevant Medical Devices Directives. One of the fundamental requirements of the Directives is the provision of ‘technical documentation’: essentially the key document that contains the evidence on how a manufacturer meets the Essential Requirements of a particular Directive for a particular device. This article focuses on the technical documentation requirements of Directive 93/42/EEC, which are also applicable to Directive 90/385/EEC (on active implantables) and, to some extent, Directive 98/79/EC (on in vitro diagnostics). The article also touches on some of the expectations for technical documentation under the proposed Medical Device Regulation. More >>

European News

  • Europe permits limited use of lead, cadmium, hexavalent chromium and PBDE in refurbished parts for medical devices
  • Team NB elects new Committee; sets up groups to interpret new European device/IVD Regulations
  • Finland restricts use of certain hazardous substances in electrical and electronic equipment
  • Italy announces new rules for Certificate of Free Sale applications
  • UK updates guidance for manufacturers on clinical investigations of medical devices

More >>

North American News

  • Canada announces annual fee increases for medical device activities
  • Special access and custom-made devices: Health Canada publishes guidance
  • Health Canada seeks comments on updated guidance concerning risk-based classification system for IVDs
  • US FDA’s new Commissioner of Food and Drugs is Dr Robert M Califf, MD
  • PMAs now required for two types of MoM total hip replacement devices
  • EPPG devices reclassified in Class II; PSAs get new Class II classification
  • Reclassification and revised identification for the membrane lung device for long-term pulmonary support
  • Scalp cooling system to minimise chemotherapy-induced alopecia becomes Class II
  • Most powdered medical gloves will be banned in USA under new proposal
  • FDA proposes Class II classification and prescription status for posterior cervical screw systems
  • Blood establishment computer software (BECS) and BECS accessories proposed for Class II classification and pre-market review
  • Reclassification of blood lancing devices proposed
  • Recommendations for pre-market notifications for lamotrigine and zonisamide assays
  • Guidance issued to support marketing authorisation of radiation biodosimetry medical countermeasure devices
  • Guidance issued on clinical trial designs for devices that affect fungally-infected nails
  • Guidance on assessment of RF-induced heating in the MR environment for multi-configuration passive medical devices
  • Technical performance assessment of digital pathology WSI devices: guidance published
  • FDA issues advice on applying human factors and usability engineering to medical devices
  • List of highest priority devices for human factors review is drafted
  • Human factors studies/clinical study considerations for combination products
  • FDA drafts enforcement policy on use of NHRIC and NDC numbers in relation to UDI rule
  • Recommendations drafted for the characterisation and testing of orthopaedic devices that use UHMWPE
  • Information to be included in a 510(k) for display devices for diagnostic radiology: guidance drafted
  • Feedback sought on proposed labelling requirements for permanent female sterilisation implants
  • Neurological devices targeting disease progression and clinical outcomes are the subject of new draft guidance
  • FDA and NIH draft Clinical Trial Protocol template
  • Recommendations for the design and development of interoperable medical devices are drafted
  • Modifications to the list of US FDA-recognised standards
  • NEMA publishes Good Refurbishment Practices for electromedical equipment
  • AdvaMed names Scott Whitaker as its new President and CEO

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Central and South American News

  • Brazil solicits comments on amendments to grouping criteria for product registration purposes
  • Medical displays are now Class IIa devices in Colombia
  • Mexico outlines plans to improve third-party review process for medical devices

More >>

Asia, Africa and Middle East News

  • Australia adds specific timeframes to legislation for notification of custom-made devices
  • Australia updates guidance on regulatory requirements for in-house IVDs
  • Australia consults on draft clinical evidence guidelines
  • China publishes Good Clinical Practice requirements for medical devices
  • Hong Kong’s Medical Device Control Office has relocated
  • India requires online submission of registration and import applications for notified medical devices
  • Medical devices to be separated from pharmaceuticals under proposed Indian regulations
  • Israel consults on proposed changes to mandatory standard for male condoms
  • Revision of mandatory Israeli standard for sterile surgical rubber gloves proposed
  • All medical devices require registration in Kenya before 1 July 2016
  • Korea amends classification list for medical devices and diagnostics
  • Korea proposes harmonising standard specifications for medical devices with international standards
  • Malaysia publishes new guidance documents on refurbishment, Declaration of Conformity and advertising
  • Malaysia holds public consultation on draft medical device recall guideline
  • Philippines drafts WEEE guidelines
  • Singapore simplifies import declaration requirements for health products
  • Ukraine proposes to update its RoHS requirements in line with European Directive 2011/65/EC

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Global Interest News

  • Companies have three years to transition to new ISO 13485
  • New ISO standard supports improvement of safety of medical device connectors used in clinical settings
  • WHO releases guidance on standards applicable to IVD pre-qualification programme

More >>

Reference Section

  • Overview of the medical device regulatory requirements in Ukraine
  • Book review: Metals for Biomedical Devices
  • Checklist of manufacturer actions before, during and after the transition period for the upcoming European Medical Device Regulation

More >>