Journal of Medical Device Regulation Issue Headlines - August 2018

Focus: What is the legal liability of European Authorised Representatives?

Authorised Representatives play a distinctive role within the European Union (EU) medical device legislation. Unlike some other product areas, they are not an optional extra in circumstances where a medical device company does not have a physical location in the EU. Following publication of the long-awaited Medical Devices Regulations and recent case law, as well as the imminent departure of the UK from the EU, the question of Authorised Representative liability is considered anew. More >>

Focus: The obligations and liabilities of importers and distributors of medical devices in Europe are impacted significantly by Regulation 2017/745

On 5 May 2017, the new Regulation 2017/745 on medical devices (MDR) was enacted, with a full implementation date set for 26 May 2020. Although the transition period for Economic Operators (EOs) to conform to the MDR may appear sufficient, it makes major amendments to the regulatory environment applicable to all medical devices. All EOs, especially manufacturers, importers and distributors, will need to define accurately how the MDR impacts their day to day activities, standard procedures, and ultimately liabilities and contractual relationships with one another. The liabilities and obligations of importers and distributors of medical devices are currently governed by the laws and regulations of each Member State, since the Directives do not specifically mention those two key actors in the medical device supply chain. The MDR’s rationale is that each EO involved in the medical device supply chain must ensure that the previous operator in the chain has complied with the Regulation. In this context, importers and distributors must ensure that the manufacturer and the device comply with the MDR’s requirements before the device is placed on the market. This article explores the obligations and potential liabilities of importers and distributors of medical devices under the new MDR. More >>

Focus: Understanding the differences between the US Quality System regulation and ISO 13485:2016 and why those differences are important

Recently, there has been much discussion about how the US Food and Drug Administration (FDA) might try to revise its Quality System (QS) regulation to incorporate or match the requirements of ISO 13485:2016, However, until Title 21 of the Code of Federal Regulations Part 820 is officially revised to incorporate ISO 13485, the QS regulation is still in place and enforceable – not only by FDA investigators but now also by any and all regulatory auditors assessing against ISO 13485 since the standard explicitly requires that a manufacturer must comply with applicable regulatory requirements for all jurisdictions in which his medical device is marketed. Therefore, understanding the differences between the QS regulation and ISO 13485:2016 is still very important in the immediate future for all manufacturers marketing in the USA. More >>

Focus: Combination products and the new Medical Devices Regulation – could the EU benefit from following the US approach?

The number of combination products entering the global market has grown significantly due to advances in medical technology as well as an increase in user demand. While these products have benefitted millions of patients and hold great promise for the future of healthcare treatment, bringing them to market still involves a number of regulatory challenges, particularly within the European Union (EU). This article sets out how device/drug and drug/device combination products are currently regulated within the EU and discusses the future impact of the Medical Devices Regulation. A comparison is also drawn between the EU and US regulatory frameworks where the question is raised, ‘could the EU benefit from a Food and Drug Administration style Office of Combination Products’? More >>

Focus: An overview of the Parallel Review Program from the US Food and Drug Administration and the Centers for Medicare & Medicaid Services

Parallel Review is designed to bring innovative medical devices to the American public in an expeditious manner. To accomplish this, the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) and the Centers for Medicare & Medicaid Services’ (CMS’) Coverage and Analysis Group (CAG) have worked together to create a process that allows for review of application evidence in parallel, which may shorten the time from FDA approval to a CMS National Coverage Determination (NCD). This article by the FDA and CMS provides a brief background on the programme, explains how it works, provides a discussion on the lessons learned and the programme’s status, and presents a vision for its future. More >>

Country Overview: Regulatory control of medical device circulation in the Russian Federation

The regulatory authority in Russia, Roszdravnadzor, has authored an article on the issues surrounding market access of medical devices in the Russian Federation, both at a national level and within the Eurasian Economic Union. The article summarises the two systems for medical device and IVD registration that currently exist, including confirmation of quality, safety and effectiveness, and testing procedures. The article also looks at future plans for regulatory changes. More >>

European News

  • EU: Manual on borderline and classification issues updated
  • France: Decree on summary of characteristics for Class III/implantable devices cancelled
  • Germany: BVMed believes medical technology should be removed from proposed European HTA legislation
  • Germany: German industry associations call for urgent action to deal with Medical Devices Regulation implementation issues
  • Ireland: Proposed medical devices fees for 2018
  • Spain: CCPS replaces PMPS for online submission and management of device applications
  • Switzerland: New system for issuing Export Certificates and Manufacturing Certificates
  • Switzerland: Clinical trial approvals will be handled electronically from September
  • UK: Guidance on medical device software apps is updated

More >>

North American News

  • Canada: Further reductions to MDSAP audit durations have been announced for small companies
  • Canada: Health Canada is adopting the Global Medical Device Nomenclature (GMDN)
  • Canada: Down classification of artificial larynx devices into Class I
  • Canada: Comments sought on Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals)
  • USA: Next generation sequencing based tumour profiling test is classified into Class II
  • USA: Class II classification for the brain trauma assessment test
  • USA: Fluid jet system for prostate tissue removal classified into Class II and subject to a 510(k)
  • USA: Class II classification assigned to the endoscopic electrosurgical clip cutting system
  • USA: In vivo cured intramedullary fixation rod classified as Class II
  • USA: Microneedling device for aesthetic use classified into Class II
  • USA: Class II classification for blood establishment computer software (BECS) and its accessories
  • USA: Sharps needle destruction devices down-classified into Class II
  • USA: Exemption from pre-market notification for five types of Class II medical devices
  • USA: Certain Class II surgical apparel now exempt from pre-market notification
  • USA: Changes proposed to update the product jurisdiction regulations
  • USA: Proposed reclassification of medical image analysers from Class III to Class II
  • USA: Alternative or streamlined mechanisms for complying with the cGMP requirements for combination products
  • USA: Medical product communications that are consistent with the FDA-required labelling; guidance for industry
  • USA: Logical observation identifiers names and codes (LOINC) for IVD tests
  • USA: Updated guidance drafted on the Q-Submission programme
  • USA: Consultation underway on draft guidance concerning 510(k) submissions for metal expandable biliary stents
  • USA: Guidance drafted on recommended content and format of complete test reports for non-clinical bench performance testing
  • USA: Draft guidance issued on the policy and considerations for multiple function device products
  • USA: Draft guidance documents on recommended pre-market testing and labelling for intravascular catheters, guidewires and delivery systems
  • USA: Common questions on the HDE programme addressed in new draft guidance
  • USA: Quality System Regulation to be aligned with ISO 13485:2016
  • USA: ‘Innovation challenge’ launched to support development of novel medical devices to help combat the opioid crisis
  • USA: Modifications to the list of US FDA-recognised standards

More >>

Central & South American News

  • Brazil: Plans to replace cadastro registration with notification system for Class I devices
  • Brazil: Barcodes to be required for coronary stents and hip and knee implants
  • Brazil: Compliance with ISO 15197: 2013 is mandatory for self-testing blood glucose monitoring systems and their consumables
  • Brazil: Import checks will focus on products of greater risk and companies with a poor track record
  • Brazil: ANVISA plans to propose the addition of ‘systems’ to IN 03/2015
  • Mexico: Guidance published on digital advertising of medical devices

More >>

Asia, Africa & Middle East News

  • Australia: 2018 fees and charges released by the Therapeutic Goods Administration
  • Australia: Application fee now charged for a Class I medical device ARTG entry
  • Australia: Therapeutic Goods Advertising Code 2018
  • Australia: Proposed regulatory changes to personalised and 3D printed medical devices put on hold
  • Australia: Guidance on the regulatory requirements for in-house IVDs is updated
  • China: Proposals to relax certain requirements for renewals, clinical trial applications and Ethics Committee approvals
  • China: Significant and wide ranging changes proposed to medical device regulations
  • China: Electronic Regulated Product Submission system proposed
  • Egypt: All medical devices to be registered from 1 September 2018
  • Hong Kong: Updates made to the ‘Guidance Notes for Listing of Importers of Medical Devices’
  • India: Draft guidelines on the Essential Principles for safety and performance of medical devices
  • India: Confirmation of effective date for IS/ISO 15197 affecting glucometer test strips
  • India: DTAB proposes amendments to Medical Devices Rules, 2017, including more notified medical devices
  • Kenya: Device standards expected to be adopted in September 2018
  • Korea (Republic of): MDITAC renamed as NIDS
  • Korea (Republic of): Adverse event reporting requirements to be strengthened under proposed changes
  • Korea (Republic of): Criteria set for medical devices using virtual or augmented reality technology
  • Korea (Republic of): Smart Healthcare Cybersecurity Guide issued by MSIT
  • Malaysia: Medical device registration requirements now fully enforced
  • Malaysia: Exemption from registration for export-only medical devices
  • Malaysia: Recognition and listing of institutes or laboratories capable of providing clinical evidence or performance evaluation data for conformity assessment
  • Malaysia: Control of orphaned, obsolete and discontinued medical devices
  • Philippines: New draft fee schedule for medical device licensing and registration
  • Saudi Arabia: Registration deadline for low-risk Class I devices extended
  • Saudi Arabia: Guidance updated on shipment clearance procedures
  • Saudi Arabia: Guidance on requirements for listing non-sterile, non-measuring, low-risk medical devices
  • Singapore: Legislative changes offer faster access to medical devices and improved clarity on regulatory controls
  • Singapore: Consultations held on nine medical device guidance documents

More >>

Global Interest News

  • IMDRF: Consultations being held on guidance documents concerning adverse event reporting, labelling and UDI
  • ISO: Latest revisions of ISO 14971 and ISO/TR 24971 with national standards’ organisations for comment
  • ISO: Voting open on ISO/DIS 14155:2018(E)

More >>