Browse English Issue Headlines - November 2013

EN ISO 14971 – a standard with a chequered history and patchwork future

The current European standard on the application of risk management to medical devices is EN ISO 14971: 2012. Although the content of the latest edition remains unchanged from the previous 2009 version, the relation between the standard and the European Directives cited in Annexes ZA, ZB and ZC has changed. The changes are essentially corrigenda to the deviations between the standard and corresponding Essential Requirements in the respective Directives. Haroon Atchia performs a critical examination of the correspondence between EN ISO 14971: 2012 and Directive 93/42/EEC and finds that while some of the identified deficiencies seem reasonable and logical, others indicate an incorrect interpretation of the Directive and may, therefore, require reconsideration. More >>

Post-market study requirements for medical devices in the USA

Post-market requirements mandated by the US Food and Drug Administration (FDA) may include studies of devices where data beyond those available in the applicable pre-market submission are considered necessary – either because certain questions could not be answered in the pre-market stage, or because an issue arises after the device is marketed. In almost all cases, the information is collected to determine if the potential risk to the patient increases or has increased once it is placed on the market. Susan Fromm provides an overview of the two such monitoring methods used by the FDA for collecting and analysing post-market data: post-market surveillance studies and post-approval studies. More >>

Inherent problems with EN ISO 13485: 2012 question the validity of presuming conformity to the quality system requirements of the Medical Devices Directives

During 2011, the European Commission raised an objection to the harmonisation status and the presumption of conformity of a number of European standards, including EN ISO 13485. Therefore, EN ISO 13485 was revised to try to address these issues. EN ISO 13485: 2012, Medical devices – Quality management systems – Requirements for regulatory purposes, was harmonised on 30 August 2012 by the European Commission as the new Quality Management System standard for demonstrating conformity with the quality assurance system requirements of the Medical Devices Directives, replacing the 2003 version of the standard. However, an evaluation of the revised standard by Kanwal Jit Singh reveals a number of problems remain. More >>

Regulatory science and the Medical Device Innovation Consortium

The US Food and Drug Administration (FDA) defines regulatory science as ‘the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products’. Regulatory science is aligned with the FDA’s mission of promoting and protecting public health as regulatory science can improve regulatory decision-making and facilitate innovation. The Medical Device Innovation Consortium (MDIC) was created in August 2012 to serve as a bridge between the FDA, industry and non-profit organisations to create a collaborative forum for addressing shared, strategic opportunities to improve the efficiency of the medical device industry through the advancement and application of regulatory science. This article by Beth Lindborg and Dale Wahlstrom describes the role and mission of the MDIC and its first three work programmes. More >>

European Update

  • Re-registration of import/export licence holders required in Croatia
  • EU Recommendation introduces announced audits by Notified Bodies
  • European Parliament votes on new medical device and IVD Regulations
  • IMCO votes to exclude devices from draft Consumer Product Safety Regulation
  • Norway now permits use of electronic instructions for use
  • Spain highlights inadvertent error in law affecting medical device advertising
  • Switzerland publishes new rules for medical device clinical trials

More >>

US Update

  • FDA medical device user fee update
  • Bills submitted to House and Senate to protect user fees from sequestration
  • FDA publishes final Unique Device Identifier rule for medical devices
  • FDA releases final guidance on mobile medical apps
  • Guidance issued on radio frequency wireless technology in medical devices
  • Final guidance issued on electronic source data in clinical investigations
  • IDEs for early feasibility clinical studies: final guidance published
  • Industry guidance published on oversight of clinical investigations
  • Guidance finalised on certain IRB responsibilities
  • Updated guidance on eCopy programme for device submission
  • Draft report on inclusion of demographic subgroups in clinical trials released
  • Process used to track IDE and EUA submissions updated
  • Non-clinical engineering tests and labelling for intravascular stents
  • Draft questions and answers on GLP in pre-market device submissions
  • SOP drafted to ensure rapid dissemination of scientific information
  • Oversight of wound care products containing live cells transfers to CBER

More >>

International Update

  • Registration: distribution/commercialisation of devices and IVDs in Argentina
  • Argentina proposes new rules for active medical devices
  • Argentina clarifies rules that apply to manufacturers/importers until Mercosur Resolutions come into force
  • Australia provides guidance on rules that apply to medical software and mobile apps
  • Australia publishes examples of how types of IVD software are regulated
  • Brazil’s ANVISA plans numerous regulatory updates and revisions in 2013/2014
  • Amendments made to Brazil’s Good Manufacturing Practice requirements
  • Canada plans to regulate non-corrective contact lenses as Class II devices
  • Health Canada no longer issues hard copy licences and licence amendments
  • Canada’s revised position on licensed devices used in healthcare facilities
  • Clinical trial approvals for Class III devices in China: new process drafted
  • China launches National Medical Device Adverse Event Monitoring System
  • Colombia expands list of products requiring registration as a medical device
  • Clarification on Colombia’s medical device registration requirements issued
  • Bill to regulate medical devices introduced to Indian Parliament
  • International Medical Device Single Audit Program pilot to launch in 2014
  • Malaysia drafts guidance on installation, testing/commissioning and acceptance of medical devices
  • List of medical devices exempt from registration published in Peru
  • Russia proposes simplification of the registration process for medical devices
  • Russia plans to exclude foreign manufacturers from certain device tenders
  • New Russian guidelines for IVDs to be developed
  • Singapore consults on change notification guidance for registered devices
  • New medical device rules in Taiwan effective in 2014

More >>

Environment Update

  • Minamata Convention on Mercury adopted

More >>

Standards Update

  • Peru drafts standard on non-invasive mechanical sphygmomanometers
  • Peru seeks comments on draft standard for mercury-in-glass clinical thermometers
  • Modifications to the list of US FDA-recognised consensus standards
  • US FDA extends transition deadline for IEC 60601-1 third edition compliance

More >>

Reference Information

  • Regulatory personnel on the move
  • Country overview: Uruguay
  • Elemental essentials: Post-market surveillance and vigilance – what is the difference?

More >>