Journal of Medical Device Regulation Issue Headlines - August 2015

Guest Editorial: Competitive regulatory strategy – using regulation to your tactical advantage

To most people, the phrase ‘competitive regulatory strategy’ means ‘how did my competition get their medical device to market before me’? That is not competitive regulatory strategy: competitive regulatory strategy means much more. Any regulatory professional should be able to design a regulatory strategy to get a medical device on to the market in whatever part of the globe a company is doing business at the time. The challenge is designing a regulatory strategy not simply to get a device on to the market, but to create a barrier to entry for the competition at the same time. Michael Drues describes a few examples of how regulation may be used to a company’s competitive advantage rather than simply viewing it as the cost of doing business. More >>

What is the potential impact of the new General Data Protection Regulation (GDPR) on clinical research in the medical device sector?

Valerie Surgenor takes a brief look at the current European data protection regime and the backdrop to the proposed General Data Protection Regulation (GDPR). Her article reviews the potential interplay between the GDPR and the proposed Medical Devices Regulation and the new Clinical Trials Regulation. In particular it considers: the potential impact of the extended definition of a medical device within the context of data protection; the extended definition of personal data and pseudonymisation; informed consent and the withdrawal of consent; the greater obligations placed on both data controllers and data processors under the GDPR (including privacy by design and privacy impact assessments) and how these may impact on the medical device sector generally; and the interoperability of Eudamed, the Clinical Trials Regulation and unique device identification. More >>

Implementing a robust complaint handling system for a corporate company group

A robust complaint handling system is a must for every medical device company. Nevertheless, there might be a variety of possible approaches to achieve this goal depending on the specific business field, device type and class, and the organisational structure of the medical device company or corporate company group. This article by Berlind Kalve identifies the basic points to consider when developing a robust complaint handling system suitable for the specific needs of any company group irrespective of its individual set up. More >>

Is the framework for the regulation of medical devices in Europe fundamentally flawed?

The scandal about PIP breast implants made and placed on the market with the CE marking of conformity according to Directive 93/42/EEC (as amended) has revealed numerous deficiencies in the way such products are regulated in the EU. Haroon Atchia’s article summarises various examinations of the investigations conducted by the European authorities and conclusions from independent, impartial exploration of the origin of the regulatory problem, including whether the authorities involved in ensuring the safety of the public acted appropriately and timeously. Impartial scrutiny of information in the public domain suggests that underlying, fundamental deficiencies and a flawed regulatory system remain the core of the problem. More >>

European News

  • Czech registry of medical devices (RZPRO) now fully operational
  • Europe moves a step closer to new Regulations for medical devices and IVDs
  • Safety of dental amalgam and its alternatives: SCENIHR publishes final Opinion
  • Final Opinion from SCENIHR on the safety of medical devices containing phthalates (DEHP)
  • SCENIHR issues preliminary Opinion on safety of surgical meshes used in urogynaecological surgery
  • Harmonised European standards
  • European Committee for Standardization, CEN, elects new President
  • Germany adopts benefit assessment regulation for medical devices
  • Ireland’s HPRA consults on proposed medical device fee model for full cost recovery
  • UK conducts survey on draft guidance concerning re-manufacture of single-use medical devices

More >>

North American News

  • Canada updates guidance on medical device compliance and enforcement
  • Health Canada proposes changes to list of recognised standards for medical devices
  • Canada makes further commitments for regulatory convergence with the USA
  • US House of Representatives approves ‘21st Century Cures Act’
  • Nonroller-type blood pumps: reclassification and PMA requirements
  • Class II classification for certain gastroenterology-urology devices
  • US reclassifies rectal control system into Class II (special controls)
  • Immunology and microbiology devices: Class II classification
  • Publication of technical amendment to general provisions for banned devices
  • Republication of the Final Order classifying the powered lower extremity exoskeleton
  • FDA intends to exempt 120 medical device types from pre-market notification
  • Guidance issued on content and format of abbreviated 510(k)s for EGR1 gene FISH test systems for specimen characterisation devices
  • Suggested content and format of a pre-market notification for magnetic resonance diagnostic devices (MRDDs)
  • Recommendations drafted for labelling and safety testing of heparin-containing devices and combination products
  • Draft guidance on assessment of RF-induced heating in the MR environment for multi-configuration passive medical devices
  • Clarification drafted on pre-market notification requirements for gowns intended for use in healthcare settings
  • Factors to consider when making risk/benefit determinations for IDEs contained in new draft US guidance
  • Draft guidance clarifies requirements for direct marking of medical devices with a UDI
  • Consultation held on draft guidance on adaptive designs for medical device clinical studies
  • FDA plans to withdraw 47 draft guidances published before 31 December 2013
  • Comments sought on extrapolating from existing clinical data to paediatric uses
  • Guidance drafted by the FDA on patient preference information
  • Clarification drafted on the acceptance of clinical data from outside the USA
  • Manufacturers are recommended to amend labelling for soft tissue filler implants in response to post-market safety concern
  • Interim results of retrospective review of PMA devices to assess balance between pre- and post-market data collection
  • NEMA develops supply chain best practices for electrical equipment and medical imaging manufacturers in the USA

More >>

Central & South American News

  • New Director for Brazil’s National Health Surveillance Agency, ANVISA
  • Brazil extends deadline for responding to technical enquiries on device applications
  • Criteria for registration of IVDs for HIV self-testing proposed in Brazil
  • Ecuador consults on draft Technical Regulation for surgical and examination/procedure medical gloves
  • Period of consultation held on two draft Ecuadorian Technical Regulations for walking aids
  • Presence of DEHP in PVC in medical devices must be disclosed in Peru
  • Peru issues new rules for importing donated medical devices

More >>

Asia, Africa & Middle East News

  • 2015 fees and charges released by Australia’s Therapeutic Goods Administration
  • Annual Charge Exemption (ACE) scheme implemented in Australia on 1 July 2015
  • Australia revises guidance on reduction of medical device assessment fees
  • First report on independent review of Australian medicines’ and devices’ legislation has been published
  • China implements user fees for medical devices
  • New medical device classification rules will become effective in China on 1 January 2016
  • China releases new rules on unannounced inspections of medical devices and medicinal products
  • New GMP rules for specific medical devices and IVD reagents will take effect in China on 1 October 2015
  • Hong Kong publishes list of recognised standards for medical devices
  • India issues draft National Medical Device Policy 2015
  • Malaysia extends medical device registration transition period by one year
  • Malaysia drafts four guidance documents affecting medical device industry: Good Refurbishment Practice; Field Corrective Action; complaint handling; Declaration of Conformity
  • Russia reduces registration requirements for Class I devices but increases requirements for making changes to an approved device registration
  • Barcodes are now required on some medical devices in Saudi Arabia
  • Saudi Arabia releases new guidance on clinical investigations for medical devices
  • Singapore drafts update to guidance on change notifications for medical devices
  • South Africa publishes draft Regulations for medical devices and IVDs
  • South Korea proposes addition of IVD reagents to veterinary devices’ legislation
  • Taiwan publishes new fee schedule for medical devices

More >>

Global Interest News

  • IMDRF consults on software as a medical device and the Regulated Product Submission
  • Update on third revision of ISO 13485

More >>

Reference Information

  • Overview of the regulatory requirements for medical devices and IVDs in Turkey

More >>