Browse English Issue Headlines - May 2018

Guest Editorial: Legal ownership of implanted medical devices

The number of patients receiving implanted medical devices, from artificial joints to pacemakers and internal cardiac defibrillators, continues to increase dramatically as our ageing population grows. In this Guest Editorial, the issue of legal ownership of implanted devices is covered, both during the lifetime of a patient and in a post-mortem setting. While this is an issue that has never come before the UK courts, practical guidance on the true position does exist. This article highlights an area where conflicting views can appear to be expressed. It sets out the correct position to address a lack of knowledge and explains why the ownership of an implanted medical device may vary quite properly between healthcare providers in different instances. It highlights existing guidance and recommendations from the Department of Health that reflect the importance of clearly worded consent agreements in influencing legal ownership. More >>

Focus: An examination of medical device environmental waste management regulations, systems, standards and guidance; improvements and recommendations to reduce environmental footprint and contain liability

Medical care is vital for life and the health of human beings, but waste generated from medical activities and production of medical devices represents a real problem to the natural and human world. Environmental issues – particularly medical device environmental waste issues – are largely absent from the European Directives and Regulations used by the medical device sector. The ultimate aims of this article are to: discover, analyse and evaluate the available regulations, systems, standards and guidance; identify information asymmetry and formulate improvements and recommendations; and discuss the nature and extent of medical device environmental waste produced during the manufacturing stage and throughout the supply chain. The article also evaluates if ‘environment’ in the context of medical devices is defined adequately as a concept. More >>

Focus: Does the text of the new Medical Devices Regulation help to clarify the legal status of 3D printing in Europe?

The new European Medical Devices Regulation (Regulation (EU) 2017/745) does not assign a specific legal status to three-dimensional (3D) printing and leaves unanswered the question of the applicable legislation in relation to this practice, which undoubtedly represents the future development of medical technology. Although 3D printed medical products are currently placed on the market as medical devices, the regulations are ambiguous as to whether they should be considered to be custom-made devices or mass-produced devices, or as devices manufactured by a health institution for its own use (in-house devices). This article analyses the European legal framework applicable to these medical devices, and the potential consequences for the segment of the medical device industry that manufactures mass-produced devices that are able to meet the same therapeutic needs as 3D printed medical devices. More >>

Country overview: Pakistan’s ‘Medical Devices Rules, 2017’

Pakistan’s new Medical Devices Rules, 2017 were promulgated on 16 January 2018. These Rules repeal the Medical Devices Rules, 2015, which were never formally implemented due to problems with their content. The 2017 Rules contain significantly reduced requirements for medical device and in vitro diagnostic (IVD) registration compared to the 2015 Rules, the biggest of which is removal of the requirement for certification of Good Distribution Practices for Medical Devices. This article summarises the Medical Devices Rules, 2017 and addresses topics such as the requirements for an Establishment Licence, listing and registration of medical devices, labelling of medical devices and IVDs, exemption, prohibition and sampling, fees for various activities, and many other requirements. More >>

European News

  • EU/UK: Withdrawal of the UK and EU rules in the field of industrial products
  • EU: Commission proposes Member State cooperation on Health Technology Assessments
  • EU: MDCG sets out requirements for a future European medical device nomenclature
  • EU: Biopharmaceutical industry collaboration to address drug/device combination product challenges brought about by the new Medical Devices Regulation
  • Ireland: Guide for distributors of medical devices
  • Switzerland: Mutual Recognition Agreement with the European Union on conformity assessment updated to reflect medical device legislative changes
  • Switzerland: Revisions proposed to align Swiss rules with new EU medical device regulations

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North American News

  • Canada: Medical device fees increased by 2% from 1 April 2018
  • Canada: New Digital Health Review Division to be established
  • Canada: Classification and licensing of high-level disinfectants and sterilants as medical devices
  • Canada: Adjustments to the MDSAP transition process
  • Canada: Strengthening medical device post-market surveillance and risk management
  • Canada: Updated guidance on the classification of health products at the device-drug interface
  • USA: Lynch syndrome test system classified into Class II
  • USA: Percutaneous nerve stimulator for substance use disorders has been classified into Class II
  • USA: Temporary catheter for embolic protection during transcatheter intracardiac procedures has been classified into Class II
  • USA: Class II classification for the non-absorbable, haemostatic gauze for temporary internal use
  • USA: Class II classification deemed appropriate for the surgical smoke precipitator
  • USA: Class II classification for the extracorporeal shock wave device for treatment of chronic wounds
  • USA: Revised rules for the acceptance of data from clinical investigations of medical devices
  • USA: Delay of effective date: when products made/derived from tobacco are regulated as drugs, devices or combination products; amendments to regulations regarding intended uses
  • USA: OTC denture repair kits exempt from pre-market notification (510(k)) requirements
  • USA: Technical amendments to the medical device regulations
  • USA: Post-market safety reporting for combination products
  • USA: New guidance for industry released on how to prepare a Pre-Request for Designation
  • USA: Revised guidance released on acceptance and filing reviews for PMAs
  • USA: Updated guidance published on the Refuse to Accept Policy for 510(k)s
  • USA: Policy clarification and 510(k) submissions for ultrasonic diathermy devices
  • USA: Two guidance documents published to support the development of NGS-based tests
  • USA: Proposed expansion of the abbreviated 510(k) programme to permit demonstration of substantial equivalence using performance criteria
  • USA: Medical Device Safety Action Plan

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Central and South American News

  • Brazil: Acceptance of third-party audits for Brazilian GMP certification extended to local and Mercosur manufacturers
  • Brazil: New telecommunication security requirements for medical devices
  • Brazil: National Implant Registry to be launched in May 2018
  • Mexico: Deregulation of 2242 low-risk medical devices

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Asia, Africa and Middle East News

  • Australia: Changes to the therapeutic goods advertising framework
  • Australia: Guidance on updating an existing Class 1–3 in-house IVD notification
  • Australia: Guidance for labelling medical devices to comply with the Poisons Standard
  • Bahrain: Draft GCC rules on the restriction of the use of hazardous substances in EEE
  • China: Work of the CFDA to be undertaken by a new State Market Regulatory Administration as part of institutional reforms
  • China: Draft rules for implementing UDI
  • China: Proposed rules for the registration of 3D printed medical devices
  • China: New technical guidelines have been published by the CFDA
  • China: Regulator announces two-year plan for medical device standards development
  • Hong Kong: Examples published of in vitro diagnostic medical devices classified into classes A–D
  • Hong Kong: Use of Chinese marketing approvals to satisfy MDACS listing requirements to be trialled
  • India: Fees to be charged by Notified Bodies are published
  • India: New frequently-asked-questions document on the ‘Medical Devices Rules, 2017’
  • India: Grouping guidelines for medical device licence applications
  • India: List of notified medical devices to be expanded
  • Israel: Two revised medical electrical equipment standards awaiting publication
  • Kuwait: Draft GCC rules on the restriction of the use of hazardous substances in EEE
  • Malaysia: New address for the Medical Device Authority
  • Malaysia: Implementation dates announced for guideline on registration of combination products
  • Malaysia: Licensing and device registration for Original Equipment Manufacturers (OEMs)
  • Malaysia: Import and/or supply of unregistered devices for the purpose of demonstration for marketing or for education
  • Malaysia: Updated guidance on requirements for medical device labelling
  • New Zealand: Higher fee proposed for Regulatory Statements to Foreign Governments
  • Oman: Draft GCC rules on the restriction of the use of hazardous substances in EEE
  • Philippines: New medical device registration requirements published based on ASEAN Medical Device Directive
  • Qatar: Draft GCC rules on the restriction of the use of hazardous substances in EEE
  • Saudi Arabia: Eight medical device guidance documents finalised and three undergoing consultation
  • Saudi Arabia: Draft GCC rules on the restriction of the use of hazardous substances in EEE
  • Singapore: Proposed amendments to the ‘Health Products (Medical Devices) Regulations’
  • South Africa: Clarification and guidance on medical device establishment licensing requirements
  • UAE: Draft GCC rules on the restriction of the use of hazardous substances in EEE
  • Uganda: Two standards drafted on surgical suture specifications; three on surgical suture needles
  • Uganda: Standard drafted on stainless steel used in surgical instruments
  • Yemen: Draft GCC rules on the restriction of the use of hazardous substances in EEE

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Global Interest News

  • IMDRF: Final guidance documents published
  • IMDRF: Consultation held on ‘Essential Principles of Safety and Performance’ of medical devices and IVDs
  • IMDRF: Comments solicited on ‘Definitions for Personalized Medical Devices’
  • IMDRF: Draft version of ‘Optimizing Standards for Regulatory Use’ out for public comment
  • ISO: Draft revisions of ISO 14971 and ISO TR 24971 available for review by national standards’ committees

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Reference Section

  • Book Review: ‘Biomaterials in Orthopedics’

More >>