Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in EUDAMED’s absence, the EU Commission’s specification adoption for high-risk diagnostics, and the results of MedTech Europe’s survey on the availability of medical devices in 2022. Updates from the FDA, Health Canada, China’s NMPA, Australia’s TGA and India’s CDSCO also make the bulletin this month. Read on for more…
Swissmedic shares FAQ on IVD notifications
Swissmedic has published a Frequently Asked Questions document on in-vitro diagnostic medical device notifications. Questions answered cover which in-vitro diagnostic medical devices must be notified to Swissmedic, timings for IVDD device notifications, queries regarding the IvDO, EUDAMED access, information regarding device codes, as well as details about notification costs and timings. To access the full FAQ document, see here.
MDCG releases practices and solutions for use until EUDAMED fully functional
The MDCG has released harmonised administrative practices and alternative technical solutions for IVDR, to utilise until EUDAMED becomes fully functional.
MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during EUDAMED’s absence. The practices and solutions aim to enable the relevant parties to effectively meet their IVDR obligations whilst minimising any potential additional burden. In particular, the guidance addresses cases where the exchange of information would be difficult / impossible to achieve based on the corresponding provisions within Directive 98/79/EC.
You can access the full MDCG guidance here.
EU Commission adopts specification for high-risk diagnostics
Earlier this month, the European Commission adopted common specifications for several types of high-risk diagnostics, such as HIV and SARS-CoV-2 tests. “Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022” lays down common specifications in accordance with Regulation (EU) 2017/746. The specifications set uniform and rigorous benchmarks for tests across the EU.
MedTech Europe releases Survey Report on availability of medical devices
MedTech Europe has released their Survey Report analysing the availability of medical devices in 2022 in connection with MDR implementation. The report reiterates MedTech Europe’s concern that the sector remains seriously held back by “the slow and piecemeal implementation” of the MDR, and that continuity of patient access and care are threatened – both in the EU and more than 100 countries globally that rely on European CE marking of medical devices.
To illustrate these challenges with concrete data, MedTech Europe has run a survey with the medical device industry – crafting the questions in collaboration with MedTech Europe members and the MDCG Task Force on Certification Capacity Monitoring. The data demonstrates that solutions are still urgently needed to course-correct the MDR, to ensure the ongoing availability of all categories of medical devices to patients.
You can read the full survey report here.
FDA updates final guidance on UDI Policy
The FDA has updated their guidance on Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices, to include their compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products.
Specifically, FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for:
- Class I devices considered to be consumer health products that are required to bear a UDI on their labels and device packages
- Class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, regardless of whether they are consumer health products (until 8 December 2022)
You can access the guidance here.
Health Canada continues transformation of Medical Devices Compliance Program
Health Canada is transforming its Medical Devices Compliance Program to ensure that pace is kept with scientific, market, and supply chain developments – as well as change driven by COVID-19.
The challenges presented by the pandemic have fueled a drive to build a more modern, agile, robust, and sustainable program. The program is modernizing and transforming its operations in four main areas including compliance and enforcement, regulations, business processes and information technology, and enhanced engagement.
China’s NMPA issues Medical Device Safety and Performance Guideline
The NMPA has released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, which elaborates on the risk-based approach for medical device registration review.
The NMPA specifies the general requirements for all medical devices and the procedures for which to use the guideline including:
- Determining the applicability and the method used to demonstrate compliance
- Forming the corresponding compliance evidence based on the determined method
- Arranging the formed compliance evidence into registration application materials
Australia’s TGA sets out 2022-23 import, advertising, and supply compliance priorities
The TGA has set out its priority areas for compliance activities relating to the import, advertising, and supply requirements of the Therapeutic Goods Act 1989 from 1 July 2022 to 30 June 2023.
They advise that this latest information should be read in conjunction with their Regulatory Compliance Framework and their article on how they manage advertising compliance – both of which describe their overall approach to compliance.
India’s CDSCO publishes draft overview on performance evaluation of IVDs
India’s Central Drugs Standard Control Organisation (CDSCO) has published a draft overview on the performance evaluation and external evaluation of In-vitro Diagnostic medical devices. The document is applicable to manufacturers of, importers of, and testing laboratories for, IVDs in India. You can access the full draft overview here.
That concludes our July MedTech news. Check back in August for more updates.
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