Journal of Medical Device Regulation Issue Headlines - November 2017

Focus: The impact of the new Medical Device Regulation on device/drug and drug/device combination products in Europe

It is well recognised that the new Medical Device Regulation (EU) 2017/745 will have a significant impact on device manufacturers, Notified Bodies and device Competent Authorities. However, it will also affect how the increasing number of drug/device combinations are regulated, involving Notified Bodies in conformity assessment review of integral device components, in addition to drug delivery devices marketed/provided separately. This article looks at some of the consequences of the new Regulation on both device/drug and drug/device combination products. More >>

Focus: Post-market surveillance requirements applicable to medical device and IVD product licence holders in Brazil

The Brazilian post-market surveillance (PMS) system, known as Technovigilance, is a monitoring system for adverse events and technical complaints of medical products in the post-market phase. Its purpose is to ensure the adoption of measures that protect and promote the population’s health. This article discusses two relevant pieces of legislation that are enforced for the post-market phase of the lifecycle of medical devices and in vitro diagnostic (IVD) products: Resolution RDC No 67/2009, which establishes the Technovigilance standards applicable to medical product licence holders in Brazil; and Resolution RDC No 23/2012, which establishes the obligation to execute, report and communicate field actions and market withdrawals in Brazil. More >>

Focus: Understanding the Medical Device Single Audit Program (MDSAP) and its implications for manufacturers

The Medical Device Single Audit Program (MDSAP) is part of the International Medical Device Regulators Forum’s vision of greater harmonisation, and was designed as a global approach to auditing and monitoring the manufacture of medical devices with the overall aim of improving their safety and effectiveness in the marketplace. According to the MDSAP functional statement, the purpose of MDSAP is to ‘[d]evelop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions’. This article looks at the outcomes of the MDSAP pilot, how MDSAP is being used in the participating countries, the format of the audit and dealing with non-conformities, the benefits of utilising MDSAP, and pitfalls to watch out for. More >>

Focus: Closing the gap between regulatory and HTA requirements for approval and reimbursement of high-risk medical devices in Europe

The gap between the requirements for market approval (CE marking) in Europe and for actual market access (reimbursement and coverage decisions) has been discussed extensively in recent years. Now, following the adoption of the new Regulations for medical devices and in vitro diagnostics by the European Parliament in May 2017, and implementation of the Medical Device Regulation within three years, new higher risk medical devices (Classes IIb and III) will normally require clinical investigations rather than simply performance evaluation. Only once the new Regulation has been implemented and we find out its consequences will we be able to determine whether the gap in clinical data requirements actually reduces or not. Since the need for alignment between regulatory bodies, Health Technology Assessment (HTA) assessors and payers has been recognised as an advantage for all parties – from early stages of clinical research up to post-authorisation studies – there is a trend towards increased collaboration between manufacturers, regulators and HTA assessors. This article provides further input into generic guidance for clinical investigations and their appraisals (such as outlined in MEDDEV 2.7/1 revision 4), but also to device-specific guidance documents (to be developed by the Medical Device Coordination Group, MDCG), particularly on trial designs, outcomes and comparators. An alignment on methodologies, not only among HTA institutions but also with regulators and Notified Bodies, will also provide benefits to medical device manufacturers through the sharing of a reliable, common set of principles and methodological approaches. A close exchange of views and ideas between the MDCG and HTA experts is strongly recommended. More >>

Country overview: The regulatory requirements that apply to medical devices and in vitro diagnostic (IVD) devices in Canada

This summary document, which has been reviewed and approved by Health Canada’s Medical Devices Bureau, looks at the role of the regulatory authority and the relevant legislation in place to regulate medical devices and IVD devices in Canada. It provides an overview of the classification system, as well as the requirements that apply to Medical Device Licences (MDLs), Medical Device Establishment Licences (MDELs), and the Special Access Programme. Information is also provided on the requirements for quality systems, product labelling, mandatory problem reporting, and clinical investigations. More >>

European News

  • EU: Codes and corresponding device types, application forms, and application documentation drafted for NB designation
  • EU: Products whose principal intended action (depending on PAC present in cranberry) is to prevent or treat cystitis, are not medical devices
  • France: Temporary Specialised Scientific Committee set up to address cybersecurity issues in medical device software
  • UK: MHRA issues guidance on new European medical device and IVD Regulations
  • UK: MHRA publishes guidance on human factors and usability engineering

More >>

North American News

  • Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals
  • USA: Key provisions of the ‘FDA Reauthorization Act of 2017’ relating to medical devices
  • USA: High intensity ultrasound systems for prostate tissue ablation classified into Class II
  • USA: Class II classification for the closed loop hysteroscopic insufflator with cutter-coagulator
  • USA: Cranial motion measurement device classified into Class II and special controls established
  • USA: Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid classified into Class II
  • USA: Class II classification for the organophosphate test system
  • USA: Enzyme packed cartridge classified into Class II and special controls identified
  • USA: Nucleic acid-based device for the amplification, detection and identification of microbial pathogens directly from whole blood deemed to be Class II
  • USA: Classification of the automated image assessment system for microbial colonies on solid culture media as Class II
  • USA: Oral removable palatal space occupying device for weight management and/or weight loss classified into Class II
  • USA: Class II classification for the zinc transporter 8 autoantibody immunological test system
  • USA: Mass spectrometer system for clinical use for the identification of microorganisms classified into Class II
  • USA: Class II classification for the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis
  • USA: Adjunctive cardiovascular status indicator classified into Class II (special controls)
  • USA: Class II classification for the balloon aortic valvuloplasty catheter
  • USA: Quality control material for clinical microbiology assays classified into Class II (special controls)
  • USA: Software pre-certification pilot programme launched
  • USA: Guidance issued on qualification of Medical Device Development Tools (MDDT)
  • USA: Guidance to assist in preparation of a 510(k) for a diagnostic radiology display device
  • USA: Guidance published on use of real-world evidence to support regulatory decision-making
  • USA: Design considerations and pre-market submission recommendations for interoperable medical devices
  • USA: New guidance clarifies procedures for classification of products as drugs or devices
  • USA: Guidance on establishing performance characteristics of IVDs for the detection, or detection and differentiation, of HPVs
  • USA: New guidance issued on the evaluation and reporting of age, race and ethnicity data in medical device clinical studies
  • USA: Marketing clearance of diagnostic ultrasound systems and transducers addressed in new draft guidance
  • USA: Initial recommendations drafted on utilising animal studies to evaluate organ preservation devices
  • USA: Regulatory considerations are drafted for microneedling devices
  • USA: Guidance drafted on policy clarification and 510(k) submissions for ultrasonic diathermy devices
  • USA: ‘Premarket Approval Application Critical to Quality’ voluntary pilot programme launched
  • USA: Modifications to the list of US FDA-recognised standards
  • USA: Process for recognising voluntary consensus standards updated and clarified

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Central & South American News

  • Brazil: New pathway added for GMP certification of international devices
  • Brazil: Consultation held on extending validity term of registration certificates to 10 years
  • Brazil: Ban on use of mercury in dentistry to take effect in January 2019
  • Ecuador: Second revision of Technical Regulation concerning respiratory protection equipment has been published

More >>

Asia, Africa & Middle East News

  • Australia: Articles that alter the pH of body fluids are not medical devices
  • Australia: Up-classification of surgical mesh and provision of patient information
  • Australia: Guidance on pre-submission meetings with the TGA updated
  • China: New classification catalogue will take effect on 1 August 2018
  • China: Five new technical review guidelines for registration published
  • China: Consultation held on policies to encourage medical device and pharmaceutical innovation
  • China: Seven new industry standards published
  • India: Essential Principles drafted to support ‘Medical Devices Rules, 2017’
  • India: Severe price caps introduced on knee implants
  • Israel: Proposed revision of standard for colour coded identification of single-use hypodermic needles
  • Korea: Consultation held on proposed changes to safety and adverse event reporting requirements
  • Malaysia: Medical device registration requirements to be enforced fully from 1 January 2018
  • Malaysia: Guidance on change notifications for registered medical devices updated
  • Malaysia: IMR to report on clinical evidence/performance evaluation for conformity assessment purposes
  • Russia: Draft amendments to the procedures for the registration of medical products
  • Saudi Arabia: Expedited pathway for marketing low-risk (non-sterile and non-measuring) devices is announced
  • Saudi Arabia: Guidance published on shipment clearance procedures
  • Singapore: Final guidance and FAQs document published on telehealth products
  • Singapore: Consultation held on guidance concerning IVD analysers

More >>

Global Interest News

  • IMDRF: Personalised medicine; final guidance documents; draft proposals on use of patient registry data
  • ISO: New handbook on medical device Quality Management Systems

More >>