Browse English Issue Headlines - February 2013

Guest Editorial: The proposal for a European Medical Device Coordination Group or ‘Scrutiny Committee’

Since the publication by the European Commission of the draft Regulation for the control of medical devices in September 2012 there has been considerable debate. The issue which has proved to be most controversial is the creation of a new expert committee, the Medical Device Coordination Group (MDCG), which has informally been called the ‘Scrutiny Committee’. Many professionals and patient groups believe that the new body is not sufficient and would wish to see a much stronger system of oversight with a move towards a pharmaceutical type of control system. Within some parts of the industry there is resistance and suspicion of the new Group. Dr David Jefferys summarises the proposed organisation and role of the MDCG and ponders whether the Group and its secretariat may be the precursor of a new European Medical Devices Agency. More >>

Guest Editorial: Is the European Commission meeting the needs of manufacturers, healthcare professionals and patients with the new medical device regulation proposal?

Manufacturers want efficient and cost-effective procedures to bring their devices to the market. Both patients and healthcare professionals want the safest and most effective devices available at reasonable costs. If there is ever a safety issue, the patient wants immediate and effective corrective action taken while the healthcare professional wants a rapid innovation cycle to make sure that advances in medical science are made available to the general patient population as quickly as possible. In this article, Erik Vollebregt asks: does the proposed European Regulation on medical devices achieve these outcomes? More >>

Guest Editorial: Germany’s Trial Regulation for medical technology innovations presents both opportunities and challenges

Manfred Beeres explains why the so-called Trial Regulation for new medical examination and treatment methods with medical devices, as provided for by the 2012 German Law on the Stabilization and Structural Reform of the Statutory Health Insurance, should be seen by the medical device industry as an opportunity for gaining reimbursement in cases where it might not have been feasible in the past. More >>

Guest Editorial: Does EN ISO 14971: 2012 create new problems for the European medical device industry?

EN ISO 14971: 2012, Medical devices - Application of risk management to medical devices, was added to the list of European harmonised standards in August 2012. Although the core text of the standard remains unchanged, the Foreword and Annexes ZA, ZB and ZC have been revised. One of the changes introduced by the 2012 version of the standard relates to the deletion of the application of the As Low As Reasonably Practicable (ALARP) concept to risk mitigation on the basis of economic considerations. Kanwal Jit Singh discusses why this could pose significant problems for the medical device industry and why the revised standard now conflicts with the text of Directive 93/42/EEC (as amended). More >>

Update on the regulatory situation for in vitro diagnostic medical devices (IVDs) in Asia

Although most Asian countries claim that their regulations have been set up according to the regulatory model of the former Global Harmonization Task Force (GHTF) or the Asian Harmonization Working Party, in reality every single country has its own set of regulations, technical requirements, product specifications or databanks. In areas not covered by GHTF guidance, there is great diversity in each country’s processes (e.g. sales controls or import rules). Only a few countries have built their systems entirely on the GHTF guidelines. Petra Kaars-Wiele looks at the role of the Association of Southeast Asian Nations, and provides an overview of the most recent changes to the regulations and/or guidelines for IVDs in five key Asian countries: Singapore, Malaysia, China, South Korea and Japan. More >>

Has anything changed since the 1996 comparison of efficiency of the US and EU review systems for medical devices?

It has been almost 17 years since the 1996 field research comparing the United States (US) and European Union (EU) review systems for medical devices. This article by Haroon Atchia attempts to update the comparison, identify whether any change has occurred and the consequences of the current situation. More >>

Implications of the US FDA’s proposed rule on UDIs and implementation strategies for manufacturers

The creation of a unique device identification (UDI) system would enable tracking and identification of medical devices across the entire lifecycle from production to the end user using one uniform coding system. On 10 July 2012, the US Food and Drug Administration (FDA) published its proposed rule for a UDI system in the Federal Register, which was subsequently revised on 19 November 2012. Tina Wu and Cynthia J M Nolte look at the requirements contained in the FDA’s proposed rule, discuss the benefits UDI should bring to the healthcare industry, and offer practical advice to medical device manufacturers for implementing a UDI system. More >>

European Update

  • Bulgaria updates its electronic medical device database
  • Effects of Croatia’s accession arrangements on medical device manufacturers
  • Processing import applications under Croatia’s legal exemption scheme
  • Denmark updates fee charges for medical equipment
  • Public consultation on European regulation of advanced therapy medicinal products
  • ‘Guidelines on a Medical Devices Vigilance System’ updated
  • European Parliament approves unitary patent scheme
  • Medical device advertising ‘visa’ system introduced in France
  • UK MHRA proposes new fees for medical device clinical investigations
  • UK releases guidance on electronic labelling Regulation

More >>

US Update

  • CDRH reorganisation
  • Bill to create an Office of Wireless Health at the FDA
  • Strategic priorities for the CDRH in 2013
  • Medical device excise tax enters into force
  • New cGMP requirements for combination products take effect July 2013
  • Reclassification of blade-form endosseous dental implants proposed
  • Reclassification of external cardiac compressors proposed
  • Proposed reclassification for device components used in ECMO system
  • Proposal for metal on metal hip replacements to require PMA/PDP
  • CDRH announces improvements in pre-market device reviews
  • CDRH launches new Export Certification and Tracking System
  • Final guidance on eCopies comes into force
  • Determination of administrative completeness of a PMA: final guidance
  • Final guidance published on ‘refuse to accept’ policy for 510(k)s
  • Content of IDEs and PMAs for artificial pancreas device systems: guidance
  • Post-approval modifications to a combination product: draft guidance issued
  • Guidance drafted on electronic source data in clinical investigations
  • Design considerations for home-use devices: draft guidance circulated for comment
  • Guidance drafted on certain IRB responsibilities
  • Comments sought on HMMDs draft guidance
  • CDRH publishes proposed guidance development lists for 2013

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International

  • Australia consults on pre-market assessment changes for medical devices
  • China announces 17 medical device management product classifications
  • New medical device vigilance guidelines introduced in Egypt
  • India issues new regulatory guidances for medical device industry
  • Indonesia introduces electronic registration system for medical devices
  • GHTF/IMDRF update
  • Mercosur Resolution helps harmonise GMP requirements in Latin America
  • AHWP sets new goals and endorses documents for Asian device industry
  • Australia/Brazil/Canada/USA sign up to single medical device audit programme
  • Australia/European Union amend MRA on conformity assessment
  • Australia/New Zealand make progress on joint therapeutic products’ scheme
  • Malaysia publishes new Medical Device Regulations
  • Malaysia issues classification guidance for borderline products
  • Pakistan establishes new Drug Regulatory Authority
  • Changes introduced to Russia’s medical device regulations
  • Singapore creates expedited access for Class C and D medical devices
  • New QMS requirement for Class A medical device dealers in Singapore
  • South Korea proposes changes to classification of medical devices and IVDs

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Environment Update

  • UN Convention confirms use of mercury to be phased out in most devices
  • South Korea plans to implement REACH by 2015

More >>

Standards Update

  • Mexico publishes standard on GMP for device establishments
  • Mexico publishes standard on implementation of a technovigilance system
  • Modifications to the list of US FDA recognised standards

More >>

Reference Section

  • Regulatory personnel on the move
  • Country overview: Tanzania

More >>