Our MedTech news for October 2024 covers the EU Parliament resolution on MDR revision, MDCG guidance on IVD qualification and legacy devices respectively, and the next deadline regarding swissdamed. MedTech news from the US also features, spanning updates relating to the FDA Safety and Performance Based Pathway, recent biocompatibility draft guidance, and a useful digital and AI glossary. Keep scrolling for the latest from China’s NMPA, including updates on overseas on-site inspections and new industry standards…
MedTech news from the EU & Switzerland
EU Parliament submits resolution on urgent need to revise MDR
On 21 October, a European Parliament resolution on the urgent need to revise the Medical Devices Regulation (MDR) was submitted to the European Council. The resolution calls for measures to address the most pressing challenges and bottlenecks relating to the implementation of MDR and IVDR by early 2025.
MedTech Europe has proposed immediate action in line with the resolution to ensure the availability of medical devices for patients. Its proposal includes reducing initial assessment timelines and costs – alongside improving assessment predictability, as well as improving the efficiency of assessments of changes to medical technologies, building an accelerated pathway for breakthrough innovation, and adapting certification timelines to follow a life-cycle approach.
According to MedTech Europe, the European Commission indicated the aim to issue the call for evidence and public consultation by the end of this year, with the results of the evaluation needed from the EC by the end of 2025.
Given that the outcome of the evaluation could lead to a structural revision of the regulations, our Regulatory team will be keeping a close eye on developments. In the meantime, you can find out more about the resolution here, and read MedTech Europe’s full reaction here.
MDCG publishes guidance on qualification of IVD medical devices
This month the MDCG published guidance to clarify which products fall under the scope of the IVDR.
To qualify as an in vitro diagnostic medical device or an accessory, your product must meet the specific definitions outlined in Art 2(2) or Art 2(4) of the IVDR. The intended purpose of the product, as described by the manufacturer, plays a crucial role in determining its classification.
The differentiation between the IVDR and MDR is importantly highlighted in this guidance, due to the MDR’s inapplicability to IVDs as stated in its Article 1.
MDCG 2024-11 provides non-exhaustive lists of examples of IVDs and accessories to IVDs to help guide manufacturers with device qualification.
EU Commission shares updated Notified Bodies overview
This month the EU Commission shared its latest update on the Notified Bodies overview. An overview of CABs/NBs at each stage of the designation process is included, as well as figures for MDR & IVDR applications, preliminary assessment reports, JAT CAPA Plan reviews, DA Final Reports, JAT Final Opinions, MDCG Recommendations, and NANDO.
MDCG updates guidance on MDR application to legacy devices
The MDCG has updated its guidance on the application of MDR requirements to legacy devices, and to devices placed on the market prior to 26 May 2021. The adjustments in MDCG 2021-25 Rev.1 take into account Regulation (EU) 2023/607 which amends MDR and IVDR regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The substantial changes include clarification that Article 19 MDR does not apply to legacy devices, clarification of the application of the transitional provisions to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) MDD, and clarification regarding the requirement to implement a QMS in accordance with Article 10(9) MDR.
Access the revised guidance here.
Swissdamed deadline for data validation: 13 November
All economic operators registered with Swissmedic with a CHRN are required to validate their data that’s been migrated to swissdamed by 13 November this year. With almost 1,000 actors having already completed validation, Swissmedic are urging those remaining operators to take the ten minutes required to check their company data, and the data of each individual registered actor.
See the five steps you need to take to validate your data here.
MedTech news from the US
FDA updates Safety and Performance Based Pathway
The FDA has published additional guidance documents for specific devices as part of its Safety and Performance Based Pathway update. The additional guidance spans performance criteria for dental impression materials, dental ceramics and cements, air powered dental handpieces and air motors, and endosseous dental implants.
Find out more about the guidance here.
Comment period extended for biocompatibility draft guidance
The FDA has extended the comment period for its draft guidance: “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to 19 December this year. The guidance document provides the FDA’s recommendations regarding methods for analytical chemistry testing to assess the biocompatibility of medical devices.
Read the draft guidance and submit your comments here.
FDA shares digital health and AI glossary
The FDA has published its digital health and artificial intelligence glossary. As a compilation of commonly used terms in the digital health, artificial intelligence, and machine learning space and their definitions, the glossary is intended for general educational purposes. The definitions provided are either taken from, or adapted from, various public sources. See the full glossary here.
MedTech news from China
NMPA resumes overseas on-site inspections
This month China’s NMPA has resumed its overseas on-site inspections after a pause in 2020 due to COVID-19. Manufacturers will now be required to comply with several key steps when notified of an overseas inspection, including submitting a “letter of authorisation” and a “basic information table of overseas inspecting products” to CFDI within 20 working days. Key documents and materials relating to the inspected site will need to be provided within 40 working days of receiving the inspection notice. Find out more about the guidelines for overseas inspections here.
NMPA releases 34 industry standards
On 8 October, the NMPA released 34 newly established or revised industry standards to provide guidance to manufacturers relating to type testing, pre-clinical, clinical studies, and regulatory submissions. Read more about the legally enforced industry mandatory standards here.
That concludes our October 2024 MedTech news roundup. Check back in November for more medical device news and updates.
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