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Browse English Issue Headlines - August 2007

Learning From Each Other in an Expanding Europe

Twinning projects are designed to build capacity in countries seeking entry to the European Union (EU), as well as those that have recently joined. The EU has committed over 1 billion euros, encompassing more than 1100 projects, delivered in over 25 countries under this initiative. Jeremy Mean’s article describes how, from 2002, the UK Medicines and Healthcare products Regulatory Agency worked with the pre-accession Czech Republic’s State Institute for Drug Control (SUKL) in a twinning project designed to prepare SUKL to meet the conditions on entry into the EU. The project has continued after accession in co-operation with the French Health Products Safety Agency.

Directive 2005/50/EC on the Reclassification of Hip, Knee and Shoulder Joint Replacements

From 1 September 2007, Member States must apply the provisions of Directive 2005/50/EC that reclassify hip, knee and shoulder joint replacements from Class IIb (medium risk) devices to Class III (high risk) devices. The reclassification of hip, knee and shoulder joints was considered appropriate because of their sophistication, weight-bearing requirements, and the possibility of the need for revision surgery over time. The impact of the reclassification will mean that Notified Bodies must perform an examination of a design dossier for these devices and that an assessment of any changes to an approved design will be required prior to placing a modified device on the market. Since the Directive came into force on 1 September 2005, a number of questions have arisen concerning the interpretation of its requirements, particularly with respect to its scope and its transitional arrangements. Earlier this year, the European Commission published a guidance document on this topic to provide clarification on a number of points and to help ensure a common interpretation of Directive 2005/50/EC, as it amends Directive 93/42/EEC. This article by Victoria Clark summarises the important issues addressed by this guidance.

E-labelling & the Comitology Procedure – Outcomes of the MDD Review Process

The term e-labelling refers to innovative means for providing Instructions for Use in an electronic format for medical devices of Class IIb and Class III (e.g. on a CD-ROM or a built-in screen). The latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC do not include an explicit rule on e-labelling but introduce an amendment to an Annex of the Directives that will be pivotal for e-labelling. Furthermore, the reference made in Directive 93/42/EEC to the planned implementation of the new regulatory procedure with scrutiny provisions (an amendment of Decision 1999/468/EC by Decision 2006/512/EC) for so-called ‘quasi-legislative measures’ determines the legal framework for e-labelling. Even though the new regulatory procedure was introduced to balance the weaknesses of the current comitology procedures, it is not capable of setting the European Parliament and the Council on an equal footing. Instead, the latest developments will lead not only to a prolongation but also increased complexity of the implementation process. One other negative factor is that independent expert advice is still not provided. Faced with the expected result that detailed rules on e-labelling need to be developed within the framework of comitology, stakeholders should prepare to give the necessary input of information based on their expert knowledge. In this article, Ulrich M Gassner examines the legal framework for e-labelling, the political and legal background of the new regulatory procedure with scrutiny and its subsequent application.

Update on the US FDA Medical Device User Fees

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was a significant, and some say, overdue milestone in the history of the medical device industry in the USA. In addition to many other provisions that were added to the Food, Drug and Cosmetic Act, MDUFMA now authorised the US Food and Drug Administration’s Center for Devices and Radiological Health to levy fees for the review of marketing applications for medical devices. As with many other laws in the US, this law will not exist forever. Section 107 of MDUFMA is a Sunset Clause which terminates the Act on 1 October 2007, and which requires medical device user fees to be formally reauthorised by new legislation in 2007. Although there are a number of bills that include reauthorisation of the medical device user fee, passage of any of them is still pending. In her article, Rosina Robinson discusses the newly proposed fee levels and requirements but, as she points out, these have not yet been finalised and the final law may very likely include other elements unrelated to medical device user fees themselves.

European Update

  • New Czech guideline on EAN codes
  • Advanced therapies regulation
  • REACH enters into force
  • MEDDEV on borderline issues
  • MEDDEV on vigilance
  • Mercury measuring instruments
  • Chemicals classification, labelling and packaging
  • NBOG meeting report
  • Reprocessing of medical devices: questionnaire
  • Eucomed publication on minimally-invasive surgery
  • France to help Serbia align its device legislation with EU
  • German regulatory developments
  • German guidance on certification of OEM devices
  • Clarification provided on Norwegian language requirements
  • Swiss revise conditions for clinical trial insurance
  • UK penalised for failing to transpose WEEE Directives on time
  • UK MHRA Medical Device Alerts

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US Update

  • Postponement of 2008 registration for device establishments
  • Mammography facility inspection fee increases
  • Appropriations Subcommittee votes to increase funding
  • General hospital and personal use devices: classification
  • Gene expression profiling test systems: classification
  • Computerised labour monitoring systems: classification
  • Intervertebral body fusion devices: reclassification
  • Absorbable haemostatic devices: proposed reclassification
  • Topical-use tissue adhesives: proposed reclassification
  • Reclassification petition denied for impedance plethysmograph
  • Reclassification petition denied for cutaneous electrode
  • Computerised systems used in clinical investigations: guidance
  • Neurothrombectomy devices: guidance
  • Pharmacogenomic tests and genetic tests for heritable markers: guidance
  • Performance standard for diagnostic x-ray systems: guidance
  • Assayed and unassayed quality control material: guidance
  • IVDs to detect influenza A viruses: guidance
  • Dental handpieces: updated guidance
  • Guidance on conformance of laser products with IEC standards
  • Products intended to repair/replace knee cartilage: draft guidance
  • 510(k)s for devices including antimicrobial agents: draft guidance
  • 510(k)s for pulse oximeters: draft guidance
  • Safety recommendations for external defibrillators
  • NIST issues guidelines for ensuring RFID security

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International Update

  • Registration requirement for in vivo diagnostics in Argentina
  • Fees for reconditioning medical products in Argentina
  • Commission created to oversee device advertising in Argentina
  • Australian Therapeutic Goods Amendment Bill
  • Two Australian Expert Working Groups created
  • Variants for Class III devices and AIMDs: final guidance
  • Deficiencies in applications requiring audit
  • Health technology assessment in Australia
  • Amendment to Canadian device regulations
  • Proposal on advertising of condoms in Canada
  • Canadian draft guidance on hospital bed safety
  • New Chinese importation requirements
  • Other recent regulatory developments in China
  • Phase V of Hong Kong’s MDACS launched
  • Comments sought on AHWP Safety Alert Dissemination System
  • FTAs between EU and India, Korea and ASEAN
  • EU opens negotiations with Central America and Andean community
  • EU/US cooperation on medical devices and cosmetics
  • US signs several trade agreements
  • Australia/Canada sign MoU on medical devices
  • ANZTPA
  • Australia/New Zealand answer questions on IVDs
  • GHTF
  • More regulatory staff and streamlined procedures for Japan
  • Korea’s new GMP regulations
  • New Zealand’s Therapeutic Products and Medicines Bill on hold
  • Peru amends clinical trial legislation
  • Philippines transfers medical device responsibilities
  • Saudi Arabia’s Ministers Council approves regulation on devices
  • South Africa’s draft medical device regulations
  • Taiwan to introduce HTA system
  • New Thai regulation for drug-eluting stents
  • Thailand plans to revise rules on physical therapy equipment

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Standards Update

  • Modifications to list of FDA-recognised standards
  • Portable rechargeable cells and batteries
  • NEMA publishes standard for positron emission tomographs

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Reference Information

  • Regulatory personnel on the move
  • Country overview: Chile
  • Elemental Essentials: outsourcing and subcontracting
  • Regulatory authorities of the 27 European Member States
  • Supplement: key revisions to the European Medical Device Directive, 93/42/EEC

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