Browse English Issue Headlines - February 2016

Solving the clinical evaluation riddle: how to write and maintain compliant Clinical Evaluation Reports (CERs)

Medical device manufacturers have been trying to solve the Clinical Evaluation Report (CER) riddle for years: although every medical device sold in Europe must have an up-to-date CER as part of its technical file, the industry is still confused as to what the report should contain, how to set it out, and what the standard for clinical data should be. The result is that standards vary massively and put businesses at serious risk. The 2007 amendment to the Medical Device Directive did little to clarify this issue and scandals such as Poly Implant Prosthèse have put increased pressure on Notified Bodies to be more rigorous and transparent in their handling of CERs. The issue can only become thornier when the new Medical Device Regulation is introduced, so manufacturers are rightly revisiting their CERs. In addition to this, more and more medical device manufacturers are finding that CERs that passed an initial review when the products were new, are being deemed as out of date and not suitable on subsequent inspections. Requests for amendments and recommendations are also being issued more and more frequently to businesses that actually do have some level of processes in place to update their CERs. Manufacturers therefore need to assess carefully the processes they have in place to update CERs and establish if they are comprehensive or accurate enough. Chris Rule outlines some common examples of non-compliance, addresses gaps in the available clinical evaluation guidance, clearly sets out the clinical evaluation process, and helps manufacturers attain compliance and prepare for future regulatory changes. More >>

An overview of the recent changes to the Republic of Korea’s medical device registration system

The Medical Devices Act of Korea was revised on 28 January 2015, and the changes were implemented on 29 July 2015. Related enforcement rules and regulations have also been established and are starting to be implemented by the Ministry of Food and Drug Safety, formerly known as the Korea Food and Drug Administration. Two of the main changes introduced in the 2015 revisions are the revised certification system for Class II devices, and the need for Good Manufacturing Practice inspections prior to product registration. These topics form the basis of this article by ChangSoon Choi. More >>

Market surveillance requirements of Regulation (EC) No 765/2008 and how they apply to medical devices

Regulation (EC) No 765/2008 sets out the requirements for accreditation and market surveillance relating to the marketing of products, which are aimed at enhancing the operation of existing legislation on the protection of public interests including health, safety and protection of consumers. Where two laws govern the same factual situation, a law governing a specific subject matter (lex specialis) takes precedence over a law which only governs general matters (lex generalis). Therefore, the Medical Devices Directives (lex specialis) should take precedence over Regulation (EC) No 765/2008 (lex generalis). However, where the Medical Devices Directives do not contain specific provisions with the same objectives, nature or effect as Regulation (EC) 765/2008, then the latter prevails. This article by Haroon Atchia examines the elements of market surveillance specified by Regulation (EC) No 765/2008 in relation to the requirements on the subject contained in the general European product safety legislation and the specific legislation on medical devices. More >>

European collaboration on Health Technology Assessments (HTAs) of medical devices

Health Technology Assessment (HTA) has gained increasing importance as an instrument to guide health policy for making rational decisions about resource allocation for health technologies, including medical devices. Since there is considerable overlap in the topics assessed in European countries, redundancies and duplications exist, resulting in a waste of research resources. The Cross Border Healthcare Directive (2011/24/EC) has provided the pre-requisite legislation for the creation of a voluntary network of national authorities of Member States and HTA agencies who collaborate on joint assessments. The scientific and technical co-operation is performed by the European Network for Health Technology Assessment (EUnetHTA) and is financed by grants from the European Commission. EUnetHTA’s objectives are to ensure the efficient production and use of HTAs in countries across Europe to bring added value to healthcare systems at a European, national and regional level. In this article, Claudia Wild, Nicola Vicari, Marina Cerbo and Anna Nachtnebel examine the Cross Border Healthcare Directive, the HTA Network and its relation with EUnetHTA, HTA requirements for clinical evidence on high-risk medical devices compared to approval requirements, and the benefits of HTA for health policy and for the medical device industry. More >>

European News

  • New Director for the new Danish Medicines Agency
  • Denmark releases new guidance on the customisation of medical devices
  • European Commission requests information on sterilisation of medical devices using ethylene oxide
  • European Parliament, the Council and the Commission agree on first EU-wide cybersecurity legislation
  • Safety of surgical meshes used in urogynaecological surgery: final SCENIHR Opinion
  • New head of department for medical drugs, medical devices and biotechnology in Germany
  • Additional benefit assessments in Germany only apply to a few medical technology procedures
  • Ireland’s Health Products Regulatory Authority appoints new Chief Executive
  • Olav Slåttebrekk appointed Norway’s new Deputy Director of Health

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North American News

  • Canada sets out transition plan for implementation of the Medical Device Single Audit Program (MDSAP)
  • Obama signs bill to suspend controversial US medical device excise tax for two years
  • Surgical mesh for transvaginal POP repair: up-classification and requirement for Pre-Market Approval
  • Autosomal recessive carrier screening gene mutation detection system classified into Class II (special controls)
  • Special controls established for tympanic membrane contact hearing aids
  • Class II classification for prostate lesion documentation system
  • Ultraviolet (UV) radiation chamber disinfection device classified into Class II
  • Class II (special controls) classification for gastrointestinal microorganism multiplex nucleic acid-based assays
  • Electrical salivary stimulator system devices have been reclassified to Class II and special controls established
  • Intravaginal culture systems classified into Class II and special controls established
  • Pre-market notification no longer required for Class II electric positioning chairs
  • ECT devices: proposed reclassification of certain devices and PMA requirement for others
  • CES devices: proposed reclassification of certain devices and PMA requirement for others
  • Re-proposed classification and restrictions on use for IVDs for Bacillus species detection
  • New restrictions and amended performance standard intended to address risks associated with sunlamp products
  • Updated recommendations published on sterility information submitted as part of a 510(k)
  • Recommendations on pre-market studies of MIGS devices included in new guidance document
  • Guidance issued on implanted blood access devices for haemodialysis
  • Guidance clarifies terminology used for gowns intended for use in healthcare settings
  • Updated guidance on eCopy programme for device submissions
  • FDA plans to notify the public about emerging post-market signals relating to medical devices
  • US FDA drafts recommendations for medical device cybersecurity
  • Proposed re-interpretation of the term ‘convenience kits’ with respect to UDI
  • Guidance drafted to help support claims of EMC for electrically-powered medical devices
  • Draft guidance released on package type terms and discard statements
  • More time to comment on draft guidance for hearing aid devices and personal sound amplification products
  • CDRH publishes proposed guidance development lists for 2016
  • FDA announces operational phase of MDSAP and termination of ISO voluntary audit report pilot programme
  • AAMI President announces plans to retire

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Central & South American News

  • Brazil’s fee increases for medical devices and IVDs to be capped under new legislation
  • Mercury-containing thermometers and pressure gauges may be banned in Brazil under new proposal
  • Brazil consults on adding surgical sutures monograph to Pharmacopoeia
  • Ecuador revises Technical Regulation for external limb prostheses and external orthoses
  • Good distribution and transportation practices manual receives formal approval in Peru

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Asia, Africa & Middle East News

  • Australia amends IVD medical device regulations; updates classification guidance
  • Australian TGA guidance on reducing medical device assessment fees updated to include IVDs
  • China implements measures for the quality supervision of the use of medical devices
  • China’s new classification and registration rules for medical devices containing silver salts
  • Naming rules for medical device generic names issued in China
  • China publishes several draft standards for medical devices
  • Hong Kong considers regulation of medical devices used for cosmetic purposes
  • Changes and proposed changes to control of medical devices in India
  • Japan outlines new importation requirements that became effective on 1 January 2016
  • Malaysia clarifies policy on implementation and enforcement of rules relating to the refurbishment of medical devices
  • Draft labelling guidance issued by Malaysian Medical Device Authority (MDA)
  • Malaysia proposes mandatory problem reporting requirements for medical devices and IVDs
  • Malaysia’s conformity assessment procedures for devices approved by recognised countries: guidance drafted; Circular Letter No 2/2014 updated
  • Malaysia publishes draft guidance on establishment licensing procedures
  • Singapore revises guidance on Change Notifications for medical devices
  • Singapore plans to introduce new controls for medical devices used as Clinical Research Materials
  • South Africa publishes Bill to assist in implementation of amendments to Medicines and Related Substances Act, 1965
  • Device applications to be screened for completeness before undergoing technical review in Taiwan
  • New importation requirements for medical devices introduced in Vietnam
  • Vietnam drafts list of potentially unsafe healthcare products

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Global Interest News

  • IMDRF consults on proposed Essential Principles for patient registries
  • An update on the third revision of ISO 13485

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Reference Section

  • Overview of the medical device regulations in Brazil
  • Book review: Biomaterials and devices for the circulatory system

More >>