This month’s round up covers MDCG guidance regarding IVDs, an update from the EU Commission on the IVDR implementation plan, as well as final guidance, strategic announcements, tools and resources from the FDA, Health Canada and Australia’s TGA. Read on for more…
New guidance from MDCG on clinical evidence for IVDs
The MDCG has published guidance regarding clinical evidence for In Vitro Diagnostic medical devices (IVDs). MDCG 2022-2 outlines the general principles of clinical evidence and provides guidance on the continuous process of performance evaluation for IVDs as set out in the IVDR.
Aimed at IVD manufacturers, investigators and study sponsors, the document describes the approach for collecting, generating, and documenting supporting data for an IVD prior to placing it on the market. Principles related to post-market surveillance are also covered. You can access the guidance here.
Updated guidance on performance evaluation of SARS-CoV-2 IVDs
This guidance document from the MDCG concerns performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746. It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens and also detection or quantification of antibodies against SARS-CoV-2.
Whilst the content may be adapted ongoing in line with changing circumstances and increasing knowledge as the COVID-19 pandemic continues to evolve, MDCG 2021-21 Rev.1 aims to form the basis for common specifications to be adopted according to Article 9 of the IVDR in the coming months. Read the guidance here.
Verifying manufactured class D IVDs: Guidance for notified bodies
MDCG 2022-3 aims to provide guidance to notified bodies regarding their role and responsibilities concerning samples of manufactured class D devices in accordance with Annexes IX and XI of the IVDR. Best practices in performing conformity assessment procedures relating to the verification of manufactured class D IVDs are included, as well as guidance on content to include within the notified body’s procedures, pre-agreed conditions and arrangements with the manufacturer, and frequency of sample devices to be sent to the EURL. Find out more here.
EU commission publishes updated IVDR implementation plan
On 7 February 2022, the European Commission published an updated version of the implementation plan for the In Vitro Diagnostics Regulation (IVDR). The update considers the revision of the transition periods under the IVDR and provides an overview of the current level of readiness. Read more here.
FDA proposes rule to harmonise Quality System regulation
This week, the FDA published a proposed rule to harmonise the Quality System regulation for medical devices with the international consensus standard for medical devices manufacturers – ISO 13485:2016. On March 2, 2022 the FDA will hold a public advisory committee meeting to discuss the requirements and potential impacts of this proposed amendment to the agency’s regulations. The proposed rule will be open for public comments until 24 May 2022. Find out more here.
FDA releases final guidance on patient-reported outcome instruments for medical device evaluation
FDA has issued guidance that describes the principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for medical device evaluation.The guidance also provides recommendations about the importance of ensuring the measures are fit-for-purpose. You can access the guidance here.
FDA releases 2022 – 2025 Strategic Priorities
The FDA’s Centre for Devices and Radiological Health (CDRH) has published its Strategic Priorities for 2022 – 2025. A natural evolution of what was achieved through the 2018-2020 / 2021 Strategic Priorities, the CDRH has outlined that for 2022 – 2025, the focus will be placed on employee engagement, opportunity and success, simplicity, and collaborative communities. The intension is to promote diversity in the workforce, enhance organisational agility and resilience and advance health equity. Find out more here.
Health Canada: New one-stop web page for MDELs
The Medical Device Compliance Program (MDCP) has developed a one-stop web page to help manufacturers, importers and distributors easily find information about the medical device establishment licence (MDEL) online. The MDEL is an important regulatory element of ensuring that the medical devices supplied to the health care sector and consumers are safe, effective and of high quality. On the new web page users can manage their MDEL, access information on establishment licensing and inspections, and report device problems, recalls and shortages. Find out more here.
Australian TGA Webinar: 2021 Therapeutic Goods Advertising Code
Australia’s TGA has released the recording of their recent webinar that guides advertisers through the new Therapeutic Goods Advertising Code 2021. The presentation highlights the changes to the 2021 Code compared to the 2018 Code and explains compliance obligations for advertisers during the six-month transition period, and from 1 July 2022 when the 2018 Code will be repealed. Access the webinar here.
That concludes our February MedTech news. Check back in March for more updates.
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