Journal of Medical Device Regulation Issue Headlines - August 2016

Editorial: How will the UK’s vote to leave the European Union affect the medical device industry?

The short answer is, of course, it is too soon to tell. However, although the precise consequences of this vote are unclear, there is little doubt that it will have significant implications for the UK and for international businesses operating in the UK. This Editorial looks at the process for withdrawal from the European Union (EU), options for continuing to trade with the EU, the possible impact on the medical device industry. More >>

Guest Editorial: Adoption of the compromise agreements on the new European Regulations for medical devices and in vitro diagnostics

On 17 June 2016, agreement was reached between the Council of Ministers and the Committee on the Environment, Public Health and Food Safety on the adoption of the Regulation on medical devices and the Regulation on in vitro diagnostics. This historic agreement was concluded after an extended period of negotiations between the European Parliament and the Council chaired by six different Member State Presidencies. Achieving an agreement has taken considerable effort: it has involved two different Parliaments, and required an extensive trilogue procedure in which the European Commission successfully brought together the differing views of the Parliament and the Member States. This Editorial highlights some of the major features of the new Regulations: the scope; reprocessing; transparency and traceability; high risk devices; clinical investigations; companion diagnostics and LDTs; and the IVD transition period. More >>

How to meet post-market surveillance requirements in today’s turbulent regulatory waters

Post-market surveillance (PMS) is a group of activities and processes that is used to monitor the safety, effectiveness and usability of medical devices once they have been placed on the market. The idea behind PMS is that if a device is not performing as intended (i.e. does not meet regulatory requirements and standards), then problems can be identified very early on. Until recently, this group of activities has been an area that many medical device manufacturers have taken a rather relaxed approach to. However, changes now being imposed by regulatory authorities, in Europe and globally, are driving manufacturers to pursue a more proactive approach when it comes to their PMS activities. This article provides a brief overview of the PMS requirements in Europe and the USA, the common challenges faced by manufacturers, and recommendations for facing those challenges. More >>

Software, apps and big data: the next health regulatory challenges for Europe

Software is playing an increasingly important and pervasive role in healthcare. It is transforming the methods used to treat patients, as well as improving the quality of care they receive, while allowing a better allocation of resources within national health systems and for care providers. There are two main, internationally-recognised categories of software: software in a medical device, defined as ‘embedded’ or ‘part of’; and software as a medical device (SaMD), which is also known as standalone software. In this article, the authors look at the current and future direction of software regulation in Europe, including mobile medical applications, eHealth and big data. They also address some of the challenges facing the medical device industry such as data privacy and security. More >>

Deficiencies in medical device manufacturer audits: a European Competent Authority perspective

As the Competent Authority for medical devices in Ireland, the Health Products Regulatory Authority (HPRA) may conduct post-market surveillance in relation to products manufactured by Irish based manufacturers and those placed on the Irish market. This post-market surveillance activity forms part of the review of a manufacturer’s compliance to the European Union Directives and related Irish legislation by the HPRA. Market surveillance is carried out by either proactive surveillance or reactive surveillance, and usually takes the form of an audit. Proactive surveillance is carried out based on what the HPRA deems appropriate (e.g. targeted audits in relation to a specific category). Reactive surveillance may be carried out by way of a ‘for cause’ audit. These audits are conducted as a result of a market issue, which requires market follow-up in the interest of public health. Following an historical review of the non-compliances issued by the HPRA during audits of medical device manufacturers/Authorised Representatives, a number of processes have been identified as the most common areas against which non-compliances were cited against different types of auditee. These findings are presented in this article, along with some examples of specific deficiencies identified by the HPRA. More >>

European News

  • Political agreement has been reached on the new European medical device and in vitro diagnostic Regulations
  • European MEDDEV guidance on clinical evaluations updated
  • Minor updates have been made to MEDDEV 2.1/6 on standalone software
  • Harmonised European standards
  • Catherine de Salins has been appointed as the new President of the Board of France’s ANSM
  • Germany’s BMG rejects new procedural rules for benefit assessments
  • BVMed in Germany re-elects Chairman for another two years
  • Lithuania amends medical device regulations
  • UK clarifies its position on the re-manufacturing of single-use medical devices
  • UK solicits comments on draft human factors and usability engineering guidance

More >>

North American News

  • Reprocessing companies have an additional 12 months to comply fully with Canada’s Medical Devices Regulations
  • Decorative contact lenses are now Class II medical devices in Canada
  • Health Canada proposes amendments to regulations for dental x-ray equipment in line with international norms
  • Next phase of Vanessa’s Law implementation involves amending medical device recall requirements
  • Labelling of IVDs is the subject of new guidance from Health Canada
  • Health Canada reiterates that CMDCAS certificates will not be accepted after 1 January 2019
  • Canada updates list of recognised standards for medical devices
  • Neil Fraser appointed as new Chair of the MEDEC Board of Directors; seven new Board members also appointed
  • US FDA will permit use of standalone symbols on medical device labelling in certain situations
  • Diurnal pattern recorder systems now Class II devices with special controls in the USA
  • Metallic biliary stent systems for benign strictures become Class II (special controls)
  • External cardiac compressors and CPR aids have been down-classified under new final order
  • Electrosurgical devices for OTC aesthetic use now Class II with special controls
  • Class II classification awarded to gynaecologic laparoscopic power morcellation containment system
  • Thermal system for insomnia: Class II classification in the USA
  • Nasolacrimal compression devices have been classified into Class I in the USA
  • US proposes to ban use of electrical stimulation devices for treating self-inflicted injuries or aggressive behaviour
  • FDA finally issues guidance on post-market surveillance
  • FDA finalises recommendations for leveraging existing clinical data for extrapolation to paediatric uses
  • Guidance offers advice on supporting a claim of EMC of electrically-powered medical devices
  • FDA releases draft ‘leap frog’ guidance on additive manufactured (3D printed) medical devices
  • FDA suggests how to evaluate and report age, race and ethnicity data in medical device clinical studies
  • Manufacturers given advice on disseminating patient-specific information from devices to patients
  • Guidance drafted on risk:benefit factors to consider in compliance and enforcement decisions
  • Advice drafted by US FDA on codeveloping a therapeutic product and an IVD
  • Clarification on the use of ISO 10993-1 in the biological evaluation of medical devices has been provided in a final guidance from the FDA
  • FDA drafts recommendations on use of Electronic Health Record data in clinical investigations
  • Revised policy on categorisation of IDEs to assist with CMS coverage decisions has been drafted
  • Infectious disease NGS Dx devices: draft guidance released for comment
  • FDA recommends use of standards in oversight of NGS-based IVDs for diagnosing germline diseases
  • Use of public human genetic variant databases to support clinical validity for NGS-based IVDs: draft guidance issued
  • Modifications to the list of US FDA-recognised standards
  • MDMA announces Paul LaViolette as new Chairman

More >>

Central & South American News

  • Brazil moves towards electronic only registration submissions
  • Mercury-containing thermometers and sphygmomanometers may be prohibited in Brazil
  • Guidance on preparing a Technical Dossier has been developed by Brazil’s Anvisa
  • Ecuador drafts Technical Regulation to specify product and establishment registration procedures

More >>

Asia, Africa & Middle East News

  • 2016 fees and charges released by Australia’s Therapeutic Goods Administration
  • Australia to implement annual charges for IVDs from 1 July 2017
  • China strengthens its medical device and IVD clinical trials supervision and inspection work
  • CFDA proposes to exempt more medical devices from local clinical trial requirements
  • China proposes a priority process for evaluating certain medical devices
  • China publishes 186 industry standards for medical devices
  • Eurasian Economic Union consults on draft medical device rules
  • India releases draft medical device regulations and withdraws 2013 Drugs and Cosmetics Amendment Bill
  • New, voluntary scheme for the Indian Certification of Medical Devices (ICMED)
  • Israel proposes revision of medical electrical equipment standard in line with IEC 60601-1 third edition
  • Korea plans to implement a fast-track approval process for 3D printed medical devices
  • Malaysia exempts certain devices from registration and exempts Class A medical devices from third-party conformity assessment
  • Malaysia issues guidance on licensing requirements for medical device establishments
  • Guidance drafted by Malaysia Medical Device Authority on change notifications for registered medical devices
  • Change of ownership for device registration: Malaysia drafts guidance
  • Saudi Arabia publishes guidance on home-use devices and chemicals used in medical devices
  • New controls for medical devices used as Clinical Research Materials come into effect in Singapore in November 2016
  • Vietnam proposes technical standards to support regulation of high frequency surgical equipment
  • Vietnam drafts Technical Regulation on safety requirements for rigid endoscopic equipment

More >>

Reference Information

  • Overview of the medical device and IVD regulatory controls in Pakistan

More >>