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Browse English Issue Headlines - November 2011

European regulation on electronic instructions for use of medical devices proceeds to become a reality

After about 3.5 years of preparation, the European Commission finalised the Regulation on electronic instructions for use of medical devices in June 2011. The document, which still needs to be enforced via the Regulatory Procedure of Scrutiny, has in the meantime passed the Technical Barrier of Trade consultation of the World Trade Organisation and has been voted on positively by the Regulatory Committee with only minor modifications. It will now be published in the Comitology Register for acknowledgement of the Council and Parliament of the European Union. Taking into account the thoughtful, intensive and indeed long-lasting discussions between the Commission, Member States, industry trade associations and Notified Bodies that resulted in the current text, there is now justified hope that this Regulation will finally be published and expectedly enforced on 1 March 2012. It will then be applied one year thereafter. A summary of the requirements of the Regulation is provided by Joachim Wilke. More >>

Examination of conformity assessment of electromedical devices in Brazil

The conformity assessment of medical devices placed on the market in Brazil exhibits various similarities and dissimilarities to the method of conformity assessment elsewhere in the world. This article by Haroon Atchia examines the specific conformity assessment requirements for electromedical devices that are promulgated in Brazilian Ordinance No 350/2010, as well as the obligations of the applicant and the manufacturer. More >>

MDD recast – Meeting the demands of the 21st century with respect to software

Nearly 10 years ago, just after entering the 21st century, the most recent revision of the European Medical Device Directive 93/42/EEC (MDD) began, based on a report from the Medical Devices Expert Group. What followed was a lengthy and time consuming process for all parties. The revised MDD was meant to provide clarification for manufacturers, Notified Bodies and Competent Authorities on issues such as clinical evaluations, technical documentation review by Notified Bodies, relevance for software, and the relationship to other legislation such as the Machinery Directive. Unfortunately, the revision failed to adapt the MDD to the needs of the new century, where in many areas software and not hardware is the key differentiator among competitors. Meike Vedder looks back to assess what can be learned from this revision process before looking forward to the MDD recast and the changes that need to be implemented to bring the MDD into the 21st century with enough flexibility to allow new technologies to be addressed properly as they emerge but also with sufficient details and boundaries to prevent national deviations. More >>

Paradigm shift on the 510(k) process? Perhaps more like a nine on the Richter scale with ‘fallout’ likely to follow?

On 29 July 2011, after nearly two years, the US Institute of Medicine held a press briefing to announce the release of its report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. The Committee issuing the report suggested that the report represented a ‘paradigm shift’ and that it truly represented the Committee consensus. The ultimate impact of this report on the 510(k) process has yet to be determined. What is clear is the report does not represent the end of the journey; it is only the beginning of the next step or steps. Only the future can tell if the Center for Devices and Radiological Health will adopt any of the report’s recommendations and when the medical device industry can be certain of what will happen next. This summary by Rosina Robinson covers the content of the IOM report and reactions to it. More >>

Reprocessing of medical devices - Is there legal certainty in Germany? Is the USA a shining example?

The reprocessing of used medical devices has been the subject of controversial discussions both in the legal literature as well as in established practice. In Germany, the discussion revolves around the question of whether the existing legal framework provides the required level of protection and quality, as well as if additional legal regulations are needed or the existing ones need further refinement for a validated reprocessing system for medical devices. There are many questions that await answers in connection with the discussion on the reprocessing of single-use medical devices, including: Is it necessary for the reprocessing company to undergo a new formal authorisation process? Are reprocessing companies subject to general product liability? Has the attending physician a duty to inform the patient of the usage of a reprocessed single-use medical device? This article by Dr Sebastian Weller aims to answer some of these questions, in particular if the existing regulations in Germany provide the required level of protection for patients. In this article, the often discussed economical considerations of the reprocessing of medical devices take a back seat to the fundamental legal issues. The article also gives an overview of the legal framework in the USA and analyses if the US system could be a viable solution for addressing the existing legal uncertainties in Germany. More >>

European Update

  • Denmark amends fee structure based on company size
  • Update on recast of European Medical Device Directives
  • Draft regulation on devices utilising tissue of animal origin
  • Manual on borderline and classification issues updated
  • German cabinet passes healthcare reform
  • IMB revises its registration forms for devices and IVDs
  • Italy introduces new requirements for data submission by Notified Bodies
  • Portugal specifies details for manufacturer’s address on labelling
  • UK Medical Device Alert

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US Update

  • FDA restructuring
  • Medical device user fees for FY 2012
  • Medical Device Regulatory Improvement Act introduced to Senate
  • FDA reform legislation introduced to House of Representatives
  • Reclassification of external pacemaker pulse generator devices
  • Classification of repetitive transcranial magnetic stimulation systems
  • Classification of the focused ultrasound stimulator system for aesthetic use
  • Classification of electrocardiograph electrodes into Class II
  • Eyelid thermal pulsation system classified into Class II
  • Pre-market approval for certain Class III pre-amendments devices
  • Updated special controls for HSV serological assay devices
  • FDA issues draft guidance on mobile medical applications
  • Draft guidance on de novo classification process
  • Draft guidance: post-market surveillance under Section 522 of FFD&C Act
  • Draft guidance on designing pivotal clinical investigations
  • Draft guidance on oversight of clinical investigations
  • Draft guidance on benefit-risk determinations
  • Draft guidance on changes to an existing device
  • Documents the CDRH is considering for development
  • FDA and CMS launch pilot programme for parallel reviews
  • New transparency report outlines proposals for enforcement data
  • New staff training for medical device reviewers
  • FDA issues SOPs for using outside network of scientific experts
  • FDA releases regulatory science report
  • Analysis of ‘Additional Information’ letters

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International Update

  • Proposed reforms to Australia’s device regulatory framework
  • Many electromedical devices now exempt from Brazil’s GMP requirements
  • New requirements for reusing/reprocessing devices in Brazil
  • Brazil sets criteria for conformity assessment of certain devices
  • Preferential treatment for Brazilian device companies
  • Canada updates inspection strategy for device companies
  • Health Canada adopts new mandatory problem reporting policy
  • Canadian guidance on device applications for implantable cardiac leads
  • Health Canada proposes to formalise use of foreign reviews
  • China proposes list of Class II devices exempt from clinical trials
  • China publishes guide on adverse event monitoring
  • GHTF documents
  • AHWP update
  • EFTA/Turkey: mutual recognition of conformity assessments
  • Malaysian parliament reviews device legislation
  • Mexico considers using third-party reviewers
  • South Africa issues new proposals for device regulation
  • Final phase of Singapore’s HPA implemented from 1 January 2012

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Standards Update

  • Harmonised EU standards
  • AAMI standard addresses sterility challenge for manufacturers
  • Modifications to the list of US FDA-recognised standards

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Reference Information

  • Regulatory personnel on the move
  • Country overview: United Arab Emirates
  • Elemental Essentials: unique device identification

More >>