Browse English Issue Headlines - May 2012

Five steps to designing an effective reimbursement strategy for medical innovations in Europe

The tightening funding environment in Europe means that a systematic approach to developing reimbursement strategies is required. Gerald Schnell and Jean-Philippe Benain describe a five-step approach for designing an effective reimbursement strategy for innovative medical technology products in Europe. Case studies demonstrate how medical technology companies can successfully shape the reimbursement environment. More >>

Preparing for a US FDA QSIT/GMP inspection

Sean Bundy and Carol Sammeth summarise what is covered in a US Food and Drug Administration (FDA) inspection for Good Manufacturing Practices of a foreign medical device manufacturer. The authors also look at how a company should prepare for such an inspection to ensure a more favourable outcome. The advice presented in this article should help a company to implement quickly comprehensive corrective action plans for any deficiencies noted during the preparation process, which will help demonstrate to the FDA that the company has acted appropriately in attempting to address any issues discovered through its own processes. More >>

Strategies and tactics for preparing a company for electronic labelling

Equally anticipated and contested, the European electronic labelling (e-labelling) Regulation has finally stepped into the spotlight. While the Regulation opens a much-needed path for the modernisation of labelling and provides the potential for improved safety and increased efficiency, there are many challenges that are best met through good strategic planning. This can help to realise fully the benefits of an e-labelling initiative such as improved patient care, faster processes, and improvements in information control, storage and distribution. In this article, Kristen Giovanis discusses six key strategies that could help a company determine if this is the proper time for implementation of an e-labelling initiative. More >>

Symbols used in medical device labelling - recommendations for emerging medical technologies

With the globalisation of trade, symbols are frequently used to convey information that is essential for the safe and proper use of medical devices. Symbols are commonly presented on labels and/or in Instructions for Use and/or in operating manuals. Whilst the medical device industry acknowledges the hard work of the various Technical Committees and Working Groups for developing standardised symbols, there is still further work to be done in the area. A review of the current harmonised European standards performed by Dr Gabriel Adusei shows that they fall short of proposing a number of useful symbols suitable for adoption and use in the medical device industry, particularly for emerging technologies. There are also many standardised symbols used in other industries that could be considered and adopted for use by the device industry. More >>

Understanding how to conduct pre- and post-market clinical studies with medical devices in Europe

Marija Capek provides a summary of the requirements in Europe for pre- and post-market clinical studies. Her article explains the difference between a clinical evaluation and a clinical investigation, the need for Ethics Committee approval, the approval process by the relevant Competent Authority, how to conduct study management and monitoring, what should be included in a final study report, plus other relevant clinical obligations. More >>

European Update

  • Merger of Danish Medicines Agency and National Board of Health
  • Commission calls for immediate action to tighten medical device controls
  • Commission regulation on electronic instructions for use published
  • MEDDEV 2.1/6 on stand-alone software
  • MEDDEV 2.2/4 on conformity assessment of IVF and ART products
  • MEDDEV 2.5/10 on Authorised Representatives
  • MEDDEV 2.14/1 rev 2 on IVD borderline and classification issues for medical devices
  • MEDDEV 2.14/4 on IVDs for vCJD determination
  • MEDDEV 2.12-1 rev 7 on the medical devices vigilance system
  • SCENIHR opinion sought on health effects of nanomaterials used in medical devices
  • German legislative changes anticipated in 2012
  • Italyís administrative fee for listing in Repertorio finally removed
  • Dutch MEB relocates
  • Portugal to transpose Directive 2011/100/EU on vCJD assays
  • UK updates advice for metal-on-metal hip implants
  • Safety concerns over oral swabs with foam heads used in UK
  • UK MHRA issues Device Alert on air- and gas-pressurised spray devices
  • Management of IVDs: revised edition of UK Device Bulletin

More >>

US Update

  • Update on the FDA medical device user fee programme
  • IRS releases proposal for implementing 2.3% medical device tax
  • Senators introduce bipartisan effort to make medical devices safer
  • Senate Bill to remove regulations slowing innovation
  • Bill introduced to limit predicate devices used in 510(k) process
  • Congress Bill hopes to develop more devices for children
  • Classification of NIR brain haematoma detector into Class II
  • Reclassification of the sorbent haemoperfusion system
  • Class II classification of endovascular suturing systems
  • Classification of norovirus serological reagents
  • Microbiology devices: proposed reclassification
  • Guidance on considerations used in PMA and de novo decisions
  • Guidance on ISO 13485 voluntary audit report submission pilot
  • 513(g) requests for information: guidance on user fees and procedures
  • Continuing review of a clinical investigation by an IRB: guidance
  • Draft guidance on standardising electronic study data
  • New transparency report outlines initiatives for enforcement data

More >>


  • Argentina establishes list of authorised implants
  • Regulatory requirements for in-house IVDs in Australia
  • Australia simplifies medical device adverse event reporting system
  • Organisational changes at Brazilís Anvisa
  • Brazil publishes requirements for breast implants
  • Brazil introduces new risk reduction rules for medical devices
  • Health Canada increases fees by 2% from 1 April 2012
  • Plano contact lenses to be classed as medical devices in China
  • China issues standard for device testing institutions
  • Foundations for Trans-Tasman therapeutic products regulatory scheme
  • GHTF seeks feedback on IVD clinical performance studiesí guidance
  • Kenya asks for comments on draft medical device regulations
  • Malaysia approves Medical Device Act 2012 and Medical Device Authority Act 2012
  • Mexican medical equipment agreement extended to include Japan
  • Peru to amend certain medical device regulations
  • South Africa consults on draft Bill to create health products authority

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Environment Update

  • New European classification and labelling inventory of hazardous substances
  • US continues to permit air shipment of lithium batteries
  • US EPA allows flexible use of alternatives to mercury-containing industrial thermometers

More >>

Standards Update

  • Comments sought on draft Chinese standard on spectacle lenses
  • EN ISO 13485: 2012 awaiting harmonisation
  • Update on national implementations of IEC 60601-1: 2005
  • ISO/IEC guide to improve safety aspects in medical device standards
  • Israel updates medical electrical equipment standards
  • Saudi Arabia to adopt medical electrical equipment standards
  • Uganda seeks comments on surgical instruments/materials standard
  • Uganda drafts standards for medical examination gloves
  • Compulsory certification of syringes in the Ukraine
  • Modifications to the list of US FDA-recognised standards

More >>

Reference Section

  • Regulatory personnel on the move
  • Country overview: Japan
  • Elemental Essentials: frequently-asked questions on Directive 93/42/EEC, as amended

More >>