In the Spotlight – Medical Devices
By Jean Smart, RAC
The big news in Regulations this year is on Medical Device. This issue provides a round the world glance at the lead agencies on what expected in 2020 for devices as many changes are anticipated.
The term Medical Devices, as defined in the Canadian Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
Canada (Health Canada)
In the last month, Health Canada has released three long-awaited documents which can be found on the Health Canada website under Medical Device.
- Notice: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification[2019-12-18]
- Scientific Advisory Committee on Health Products for Women (SAC-HPW) Summary: Findings, Advice, 2019-05-16 and 17[2019-12-06]
- Scientific Advisory Panel on Digital Health Technologies (SAC-DHT) Record of Proceedings 2018-11-23[2019-12-10]
EU has announced that they will not be extending the new Medical Device Regulation effective date, except for the four-year pushback for some Class I devices. The new EU Medical Device Regulations come into effect in May 2020. Many device companies are not ready for the launch as the MDR device database, called Eudamed, was delayed in development for two years. The EU Medical Device Coordination Group has released several MDR guidance documents to assist with the transition:
- Class I devices,
- persons responsible for regulatory compliance and implant cards,
- sampling and MDR codes,
- classifying software,
- safety and clinical performance summaries,
- transitional provisions,
- unique device identifiers
The Association for the Advancement of Medical Instrumentation has released a report on technical information to help the US industry prepare for the revision to 21 CFR 820 which will harmonize with medical device ISO 1345:2016.
Several important FDA Medical Device rulemakings and guidances are expected in 2020:
- February 2020 – clinical holds in medical device investigations
- February 2020 – patent term restoration
- April 2020 – Draft on the modernization of the quality system regulation for medical devices.
- Fall 2020 – pediatric study plan requirements,
- Fall 2020 – excluding certain medical software functions from the definition of a device
- December 2020 – biologics regulation modernization
- December 2020 – revised draft guidances on postmarket surveillance of devices and post-approval studies.
A report on postmarket surveillance of medical devices is also expected to be issued by the Office of Inspector General this year.
In Japan, pharmaceuticals and medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). Japan took the lead and began revising its medical device regulations in 2014 with the restructuring of the agency. The new review process for new applications and clinical trial applications has recently been implemented and the organizational structure is now by risk level and category: new devices (including novel devices), improved devices and generic devices.
The hottest topic this year in Medical Device are the “novel technology devices” which are new apparatus, appliance, software or material with novel technology never before approved for use. Other hot topics are in Regulatory reviews, Action Plan on Medical Devices, Digital Health Technologies, Safety, Effectiveness and Quality of Medical Devices, Medical Device Life Cycle and Clinical Trials (Investigational Testing). There are a lot of changes coming and the International Medical Device Regulators Forum (IMDRF) is the lead agency promoting medical device regulatory harmonization and convergence.
For more information, please contact Jean Smart.