January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken to adapt to the ongoing COVID challenges.

Our MedTech news round up this month covers Health Canada’s proposed changes to their recognised standards for medical devices, plus their amendments to post-market surveillance provisions, FDA’s new AI / ML action plan, plus their guidance for Q-submissions, the MHRA’s issuing of post-Brexit medical device and IVD registration requirements, and the EU Commission’s notice on audits by notified bodies.

Health Canada announces proposed changes to list of standards for medical devices

Health Canada has announced proposed changes to the Medical Devices Directorate’s (MDD) Draft Guidance Document: List of Recognised Standards for Medical Devices.

The proposed changes include:

• 14 new standards to be added
• 29 new editions of currently recognised standards
• 3 standards to be removed

The 14 new standards to be added cover cardiovascular, dentistry, medical electrical equipment, medical devices, surgical implants, ophthalmic implants, prosthetics, spinal discs, bone screws, and mammographic equipment, whilst the three standards to be removed involve metal-ceramic dental restorative systems, electromagnetic compatibility, and the application of usability engineering.

As of January 15, 2021, Health Canada has invited interested parties to provide comments and suggestions until the deadline of March 16, 2021. Following this date, they will then publish the results online via the Health Canada website.  You can access the Consultation Document here.

FDA publishes Artificial Intelligence / Machine Learning Action Plan

On January 12, 2021 FDA released their first Artificial Intelligence / Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.

Describing a “multi-pronged approach” to advance their oversight of AI / ML- based medical software, the FDA’s action plan outlines five actions that they intend to take including:

• Further development of the proposed regulatory framework including the issue of draft guidance on a predetermined change control plan for software’s learning over time;
• The development of good machine learning practices to evaluate and improve machine learning algorithms;
• Taking a patient-centred approach, including addressing device transparency for users;
• The development of methods to evaluate and improve machine learning algorithms;
• The advancement of real-world performance monitoring pilots.

The action plan comes in response to feedback received from the April 2019 discussion paper Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device. You can download the Action Plan here. And for more on Artificial Intelligence, read our latest topical articles, available here.

UK MHRA issues post-Brexit requirements

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued post-Brexit medical device and IVD registration requirements.

Class I medical devices, IVDs and Custom-made devices are listed as requiring registration with the MHRA under existing arrangements. All other classes of device placed on the UK market require registration with the MHRA subject to grace periods, depending on the class of devices.

MHRA notes that in Great Britain, devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be registered with the MHRA. Registration requirements under those regulations differ for Northern Ireland however.

The full guidance covers who must register and when, information required when registering your device, how to access the Device Online Registration System, the fees involved in registration, how to make changes to your registration and details on the public register of manufacturers.

Find the guidance, as well as some video tutorials, here.

COVID-19: Commission Notice on audits to be performed by notified bodies

The EU Commission has published a notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment.

Following calls from the industry to allow temporary extraordinary measures such as the facilitation of remote audits due to the potential risks caused by the COVID-19 pandemic, the Commission has provided a response.

The notice states that the Commission recalls the obligation of Member States authorities to monitor notified bodies established on their territory, to ensure compliance with the requirements for audits set out in Chapter I of Annex IX, sections 2.3 and 3.3, under due consideration of the principle of proportionality.

The notice goes on to say that regarding the imposition of penalties in accordance with Articles 113 and 106 respectively of the medical devices Regulations, the Commission recalls the requirement to apply any national provisions on penalties for breaches of the requirements laid down in these Regulations, also considering the principle of proportionality.

For further information on the circumstances to be considered, see here.

FDA issues guidance for feedback and meetings requests for Medical Device Q-submissions

The FDA has issued guidance for “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”.

The guidance provides an overview of the mechanisms available through which to request feedback from, or a meeting with, the FDA regarding potential / planned medical device Q-submissions. The following application types are covered in the guidance:

• Investigational Device Exemption (IDE) applications
• Premarket Approval (PMA) applications
• Humanitarian Device Exemption (HDE) applications
• Evaluation of Automatic Class III Designations (De Novo requests)
• Premarket Notification (510(k)) Submissions
• Clinical Laboratory Improvement Amendments (CLIA)
• Waiver by Applications (CW)
• Dual 510(k) and CLIA Waiver by Application Submissions (Duals)
• Accessory Classification Requests
• Certain Investigational New Drug Applications (INDs)
• Biologics License Applications (BLAs) submitted to the Centre for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act)

Take a look at the guidance here, and submit comments on the guidance, here.

Canadian regulatory amendments introduce expanded post-market surveillance provisions

Health Canada has issued amendments to the Food and Drug Regulations and the Medical Devices Regulations (CMDR) that aim to strengthen post-market surveillance for medical devices.

The amendments are in support of the life cycle amendments introduced in Vanessa’s Law, and provide regulatory authorities with greater power and more tools to evaluate and monitor incidents.

The amendments seek to address the need for detailed analysis within post-market information by granting new powers to Health Canada to compel medical device licence holders to conduct a risk assessment of their own devices in light of new information gathered. The intention is to improve efficiency in the evaluation of medical devices, to offer greater certainty to the industry, and to ensure that critical information is conveyed to Heath Canada.

Read the published SOR/2020-262 here for more information.

That concludes our January round up. Check back in February for more MedTech news.

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