MedTech news

MedTech news round up November

Posted on by Congenius

This month’s round up covers a first-of-its-kind publication from the WHO, a collaboration between the FDA, Health Canada and the MHRA, the latest MDR & IVDR updates from the EU, and news from the US and Asia-Pacific. Read on for more.

In global news…

New WHO publication: Generating evidence for AI-based medical devices

The WHO has published a first-of-its-kind publication aimed at developers and researchers of AI-based software as a medical device (SaMD). “Generating Evidence for Artificial Intelligence Based Medical Devices: A Framework for Training Validation and Evaluation” is intended to guide those seeking to understand the evidence generation requirements from development to post-market surveillance of these devices.

The publication uses cervical cancer screening as a use-case to support the WHO’s strategy on cervical cancer elimination. You can download the publication here.

A cross-Atlantic collaboration: Guiding principles for Good Machine Learning Practice

The FDA, Health Canada and the UK’s MHRA have collaborated to jointly identify 10 guiding principles aimed to inform the development of Good Machine Learning Practice (GMLP) for medical device development. The principles are designed to help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning. Find out more here.

MDR & IVDR updates from the EU…

MDCG shares draft joint implementation and preparedness plan for IVDR

The MDCG has proposed its draft joint implementation and preparedness plan for IVDR. The main aim of the paper is to stimulate agreement on where to focus limited resources in the shorter term to ensure delivery of the legislation by the date of application. The priorities set out in the document have been identified based on public health, patient safety and transparency, as well as the most urgent stakeholder needs. Read the implementation plan here.

MDCG publishes Q&A on repackaging & relabelling under MDR & IVDR

The MDCG has published a Questions & Answers regarding repackaging and relabelling obligations under MDR and IVDR. The questions covered by the document aim to guide economic operators carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) of the Regulations concerning relabelling and repackaging of devices. The Q&A is not however, intended to address quality management systems and related certification activities, nor elaborate on Article 16(1) of the Regulations. You can access the document here.

EU Commission publishes guidance on MDR requirements for legacy devices

As reported earlier this month, the EU Commission recently published guidance from the MDCG that clarifies the applicability of MDR requirements to ‘legacy devices’ and ‘old’ devices.

Requirement areas covered for legacy devices include postmarket surveillance, market surveillance, vigilance, and registration of economic operators and devices. Information on the application of MDR requirements to ‘old’ devices, which are medical devices placed on the market prior to 26 May 2021 in accordance with MDD is also included. You can read the full guidance here.

News from the US…

FDA strengthens safety requirements for breast implants

The FDA has taken several new actions to strengthen breast implant risk communication and help those who are considering breast implants to make informed decisions. Orders restricting the sale and distribution of breast implants have been issued, new labelling requirements for all legally marketed breast implants have been approved, and updated information on the status of breast implant manufacturer post-approval studies has been released. Find out more here.

FDA launches patient cybersecurity best practices video

As medical devices become more connected, their exposure to cybersecurity risks increases. To help empower patients to combat these risks, the FDA has launched its first video focussed on patient cybersecurity best practices. “Cyber Vitals: Information for Patients’ Medical Device Health” offers practical steps patients can take to protect their device and personal information. Access the video here.

CDRH shares list of proposed guidances for FY2022

The FDA’s CDRH has shared a list of guidance documents that they intend to publish this coming fiscal year (FY2022), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding their revision or withdrawal.

Three lists of guidances have been issued: the A-list which contains prioritised device guidance documents intended for publishing in FY2022, the B-list which covers guidance documents the FDA intends to publish as resources permit during FY2022, and the Retrospective review list which includes final guidance documents issued in 1982, 1992, 2002, and 2012.

For more information, and instructions on how to comment on the guidances, click here.

FDA publishes draft guidance on content of premarket submissions for device software functions

The FDA has published draft guidance which provides information on the recommended documentation to include in premarket submissions for their evaluation of the safety and effectiveness of device software functions. You can read the guidance here, and access our recently shared fact sheet resource on the guidance here.

And from Asia Pacific…

China’s NMPA publishes regulatory updates on IVD classification and self-testing

China’s NMPA has published new classification rules for in-vitro diagnostic (IVD) medical devices, as well as requirements for manufacturers to self-test their devices for registration on the Chinese market. You can access the Classification Rules for In Vitro Diagnostic Reagents here, and the Regulations for the Management of Medical Device Registration Self-Testing here. The latter also includes the required templates for self-testing submissions.

Australia’s TGA publishes FAQs on medical device reclassification

Australia’s Therapeutic Goods Administration has published a Frequently Asked Questions regarding the reclassification of medical devices. The FAQs span which medical devices are being reclassified, notification requirements, and clarification on the notification form requirements for Class IIb spinal fusion devices. Read more here.

That concludes our November MedTech news. Check back in December for our final round up of 2021.

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