Browse English Issue Headlines - November 2012

Guest Editorial: Examination of breast implant regulations in Europe

The European Union continues to deal with a scandal about mammary prostheses (breast implants) that were manufactured and placed on the market with the CE mark of conformity according to Directive 93/42/EEC (as amended) by the French company Poly Implant Prothčse (PIP). The Internet is rife with articles on this topic, many purporting to provide analysis and insight about this scandal. In addition, thousands of women have undergone difficult and potentially risky explant procedures based on physicians’ recommendations while physicians have had only contradictory and confusing guidance from governments and regulatory agencies on which to base their judgements. This situation appears to demand an autonomous and independent technical review of the ongoing international problem and the regulations governing these medical devices. Although the French company at the centre of this scandal may or may not have committed serious infractions, the research introduced by Haroon Atchia reveals numerous deficiencies in the way in which breast implants are regulated in the European Union. More >>

Guest Editorial: What’s new in the European WEEE recast?

The European Union’s Directive on waste electrical and electronic equipment (WEEE) has been recast as Directive 2012/19/EU. The new Directive introduces subtle changes that will take effect over time. These include an open scope, harmonised registration and reporting requirements, producer changes, increased collection rates, and design for recyclability. Medical device manufacturers will face a series of long-term changes in the way that WEEE is handled in several countries. Ian Smith’s Guest Editorial summarises the changes that will be introduced by the WEEE recast and looks at the impact of these changes on the medical device industry. More >>

Interview: Tatjana Sipetic, Managing Director of the Medicines and Medical Devices Agency of Serbia (ALIMS), talks to the JMDR

In this exclusive interview, Tatjana Sipetic talks about the medical device and in vitro diagnostic (IVD) market in Serbia, her position in ALIMS, and the role and future direction of the Agency. She also summarises Serbia’s current requirements for medical devices and IVDs, including the registration procedures, fees, timeframes, labelling and language requirements, and clinical investigation approval process. The Journal of Medical Device Regulation strives to provide its readers with the information they really need and want, so our subscribers were invited to pose questions for Tatjana Sipetic, which have been included in this interview. More >>

Clinical evaluation: how similar is equivalent?

In this article, Howard Dobbs highlights a significant problem inherent in the current version of the European Commission’s guidance document on clinical evaluation (MEDDEV 2.7.1 Rev 3) with respect to the meaning of equivalence. This guidance document is important because it is intended to clarify which devices can be taken to be equivalent when the so-called literature route to CE marking is followed. In fact, this guidance document is not sufficiently clear about the meaning of equivalence and as a consequence there is confusion about which devices should be approved and which should not. More >>

Language and translation considerations for medical device and IVD manufacturers entering the Latin and South American markets

There are 43 Latin and South American countries into which medical devices and in vitro diagnostics (IVDs) can be imported and sold. As a medical device or IVD manufacturer, one of the considerations to make when strategically planning marketing to this region is language, including regional dialects. Another consideration is what information will be translated. In this article, Roger Mazzella looks at the language and translation requirements for the Latin and South American region, including electronic labelling, and discusses the benefits of considering regional dialects. He also illustrates how best to determine what information should be translated for a product and shares some experiences of working in Latin/South America. More >>

An interpretive view on the European definition of ‘metabolic means’ in relation to the medical device/medicinal product borderline

John Deavin’s article examines the issues surrounding the definition of the term ‘metabolic means’ and proposes clarifications that would enable the consistent application of European Directives 93/42/EEC (as amended) on medical devices and 2001/83/EC (as amended) on medicinal products, as well as the latest version of the Commission guidance document on borderline products (MEDDEV 2.1/3 rev 3). More >>

European Update

  • Bulgaria amends Law on Medical Devices with respect to wholesale dealing
  • European Commission proposes new rules on medical devices and in vitro diagnostics
  • Regulation (EU) No 722/2012 on devices utilising tissues of animal origin
  • EMA publishes public assessment reports for ancillary drugs used in devices
  • Manual on borderline and classification issues updated
  • SCENIHR Opinions sought on hip implants, DEHP and dental amalgam
  • Commission evaluates operation and functioning of Eudamed
  • France revises draft implementation Decree for ‘Sunshine Act’
  • Germany: updated recommendations on medical device reprocessing
  • Ireland updates guide to applications for Certificates of Free Sale
  • Irish Medical Council issues guidance on marketing/promotional activities
  • Portugal transposes Directive 2011/100/EU on vCJD assays
  • Spain to transpose Directive 2011/100/EU on vCJD assays
  • UK Device Bulletin on blood pressure measurement devices

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US Update

  • Medical device user fee rates for FY 2013
  • Implementation of changes to device registration and listing requirements
  • FDA given new authority over clinical trials registry
  • FDA’s strategy for strengthening post-market surveillance
  • FDA issues guidance on review clock and goals for PMA/510(k) submissions
  • Comments sought on partially binding guidance concerning eCopies
  • Determination of administrative completeness of a PMA: draft guidance
  • Guidance drafted on ‘refuse to accept’ policy for 510(k)s
  • Draft guidance: 510(k)s for small-bore connectors used in enteral applications

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International Update

  • Australia: hip, knee and shoulder reclassification application documentation
  • Brazil consults on grouping of IVDs into product families
  • Protocol for issuing electronic certificates in Brazil
  • Health Canada consults on two guidances for Class III and Class IV IVDs
  • 73 medical device reclassifications published in China
  • China amends labelling and packaging requirements for imported devices
  • China consults on new GCP requirements for medical devices
  • India to monitor device activities and move forward with device Bill
  • Draft ASEAN Medical Device Directive released for national consultation
  • GHTF SG2 and SG5 publish final documents
  • Second meeting of the International Medical Device Regulators Forum (IMDRF)
  • Israel’s Medical Equipment Law 2012
  • Korea proposes fast-track approval of devices using STED
  • Korea drafts regulation for the labelling of medical devices
  • Proposed Regulations for veterinary medical devices in Korea
  • Consultation on Malaysia’s draft medical device regulations and fee schedule
  • Singapore lowers fees for medical device Special Authorisation Routes
  • Guidance on Singapore’s new medical device regulatory framework
  • Singapore proposes expedited approval for Class A device dealers
  • GDP for medical devices in Singapore: technical specification revised

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Environment Update

  • SCHER Opinion sought on environmental effect of mercury in dental amalgam
  • Jordan plans to control hazardous substances in electrical and electronic equipment

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Standards Update

  • Health Canada updates its list of recognised standards
  • IEC 60601 family of standards: Canadian guidance on transition to 3rd edition
  • Symbols used on devices in Europe: international standard to replace EN 980
  • Harmonised European standards
  • ISO 11987 on shelf-life of contact lenses revised
  • IEEE 11073 standards on health informatics: new; revised; under development
  • Korea proposes adoption of IEC 60601-1: 2005
  • Modifications to the list of US FDA recognised standards

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Reference Information

  • Regulatory personnel on the move
  • Country overview: the medical device regulations in Vietnam

More >>