Our MedTech news roundup for May 2024 spans a new combined studies project from the EU Commission, new guidance from EMA, results from the latest Notified Bodies survey regarding MDR / IVDR certifications and applications, and preliminary assessment review form templates from the MDCG.
Updates from Switzerland and the UK also feature, including an announcement from Swissmedic relating to the use of MDCG 2024-4, and updated guidance from the MHRA on its enforcement of medical device regulations.
And keep reading to find out the latest from the FDA on its final rule regarding LDTs, new guidance on medical device remanufacturing, and recently authorised AI / ML-enabled medical devices.
MedTech news from the EU
EU Commission presents new combined studies project
Earlier this month, the EU Commission published an analysis of the current challenges faced when conducting combined studies, and possible strategies for streamlining the regulatory landscape. The report is a collaborative effort between the Commission, national authorities, ethics committees, and the European Medicines Agency.
The analysis forms part of the COMBINE project which is an EU initiative that aims to streamline regulatory processes and reduce the time to market for innovative and personalised treatments. The project was initiated to address the issues linked to the operational interface between the EU clinical trials, medical devices, and in vitro diagnostic medical devices regulations, with the next step involving an investigation into how to develop some of the proposed solutions.
Find out more about the report here.
EMA releases new medical device guidance for industry & Notified Bodies
On 21 May EMA published a new revision of its Questions & Answers for applicants, marketing authorisation holders of medicinal products, and notified bodies, with respect to MDR / IVDR implementation.
The document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combination products. Questions and answers pertaining to combinations of medicinal products and medical devices, integral drug-device combinations, and medicinal products that include a medical device in the secondary packaging are included in the document, as well as the consultation procedure for ancillary medicinal substances in medical devices and companion diagnostics respectively.
Read more about the guidance here.
EU Commission shares Notified Bodies survey on MDR / IVDR certifications & applications
The EU Commission has shared the results of the 8th Notified Bodies survey on certifications and applications for MDR and IVDR.
The overall study, which runs until December 2025, aims to support the monitoring and analysing of the availability of medical devices on the EU market in the context of MDR / IVDR implementation from the perspectives of key stakeholders.
This latest presentation contains the results from the small and medium datasets collected in March 2024, with responses from 45 notified bodies designated under MDR and / or IVDR.
The data collected relates to MDR / IVDR applications filed and certificates issued, average timeframe between application lodged and written agreement signed, reasons for refusal, and submission completeness.
You can find the full survey here.
MDCG releases preliminary assessment review form templates
The MDCG has released form templates relating to preliminary (re-)assessment of notified bodies. The forms found within MDCG 2024-6, 7, 8, and 9 are relevant to assessing if the notified bodies meet the requirements to continue operating. There are different versions depending on whether it’s a first-time assessment (PAR) or a reassessment (PRAR), and for medical devices (MDR) or in vitro diagnostic medical devices (IVDR). You can access the suite of form templates here.
MedTech news from Switzerland & the UK
Swissmedic announces MDCG 2024-4 to be used for reports in Switzerland
During category C interventional performance studies of IVDs (pre-market studies) sponsors must report certain serious adverse events and device deficiencies with Excel tables. MDCG 2024-4, a guidance document related to this topic, was published back in April this year, and includes the Excel form for summary reports (MDCG 2024-4 Appendix).
On 16 May Swissmedic announced that this European guidance document and associated appendix should also be used for reports in Switzerland. Swissmedic also shared an information sheet regarding reporting duties (BW600_00_016e_MB).
You can access both the guidance and the information sheet here.
MHRA updates medical devices roadmap
The UK’s MHRA has updated its roadmap that outlines the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition.
The implementation of the medical devices future regime has been updated to include the intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical devices (IVDs).
MHRA updates guidance on enforcement of medical device regulations
The MHRA has updated its guidance ‘Medical devices: the regulations and how we enforce them’ to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers.
MedTech news from the US
FDA announces final rule to help ensure safety & effectiveness of LDTs
At the end of last month, the FDA announced a final rule aimed at helping to ensure the safety and effectiveness of laboratory developed tests (LDTs). The rule amends the FDA’s regulations to make it explicit that IVDs are devices under the FD&C Act including when the manufacturer of the IVD is a laboratory.
Alongside this amendment, the FDA is finalising a policy to provide greater oversight of IVDs offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as well as targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
FDA updates AI/ML-enabled medical devices list
On 13 May the FDA shared its updated list of Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices. 191 (AI/ML)-enabled medical devices have been added, and with this update, 882 (AI/ML)-enabled medical devices have now been authorised.
Of those devices newly added to the list, 151 have final decision dates between 1 August 2023 and 31 March 2024, and 40 are devices from prior periods.
You can review the updated list here.
FDA holds seventh medical device sterilization town hall
On 23 May, the FDA held the seventh medical device sterilization town hall which included a panel discussion on what to consider when choosing a sterilization method or changing methods.
The regular series of town halls is part of a multipronged approach by the FDA to reduce reliance on EtO sterilization use while ensuring the integrity of the supply chain.
The printable slides from the session are now available here.
FDA releases final guidance on remanufacturing of medical devices
Many medical devices are reusable and require preventative maintenance and repair during their useful life. For these devices, proper servicing is crucial for continued safe and effective use. There is however, a lack of clarity regarding the distinction between “servicing” and “remanufacturing” of a device. Remanufacturing in particular has regulatory implications for those performing these activities.
As such, the FDA has released final guidance to help clarify whether activities performed on devices are considered “remanufacturing”. The guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labelling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life.
Access the guidance here, and see here for more information on an upcoming webinar relating to the guidance which will be held on 27 June.
That concludes our May 2024 MedTech news roundup. Check back in June for more medical device news and updates.
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