Our April 2024 MedTech news roundup covers an update from Swissmedic on medical device software, guidance from the MDCG regarding clinical investigations and safety & performance, and a study from the EU Commission on the reprocessing and reuse of single-use devices in the EU.
Guidance from the UK’s MHRA on the combined review of clinical trials for IMPs and combination devices, draft guidance from the FDA on 510(k) submissions for animal studies for dental bone grafting material devices, and the latest from Brazil’s ANVISA on RDC 830 / 2023 also features.
Swissmedic overhauls information sheet on medical device software
Swissmedic has expanded its previous information sheet on medical device software.
An important new section on Class I medical device software (MDSW) which outlines possible MDSW functionality that would be classified as Class I under the Swiss MedDO has been added, as well as regulatory requirements aligning with the EU MDR / IVDR related to GSPRs, technical documentation, clinical / performance evaluation, and labelling & UDI.
Clearer references to the Swiss legal framework, EU legislations, MDCG guidance, and applicable standards also feature.
Read the information sheet here.
MDCG shares guidance on content of Investigator’s Brochure for clinical investigations of medical devices
Those responsible for a medical device clinical investigation are required to submit an application according to Article 70(1) of the MDR, accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of this required documentation and must contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application.
The IB is required as part of fulfilling the requirement in Section 2.7 of Chapter I of Annex XV of the MDR, which states that the investigator shall have access to technical and clinical data regarding the device that is being investigated. This includes the intended purpose, design, the fundamental scientific principles behind the design, and the level of objective evidence already in place, to assure its safety and functionality during the investigation.
MDCG issues safety reporting guidance for IVD medical devices
Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) is required under the IVDR. MDCG 2024-4 sets out the reporting modalities and formats that apply to performance studies covered by IVDR Article 58(1), Article 58(2), and Article 70(2), PMPF studies covered by IVDR Article 70(1), and combined studies of medicinal products and IVDs.
Access the full guidance here.
MDCG updates summary of safety and performance template
This month the MDCG updated its summary of safety and performance template. MDCG 2022-9 Rev.1 incorporates changes to clarification on when the SSP should be made available to patients, indication whether it is a device for near-patient testing and / or a companion, and intended use of the device.
You can access the updated template here.
EU Commission shares study and report on reprocessing & reuse of SUDs in the EU
Article 17 of the MDR regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA), which may only take place when permitted by national law and in accordance with Article 17.
This recent study from the EU Commission aims to evaluate how the provisions established in Article 17 MDR have been implemented and how such provisions function in practice. To facilitate this goal, the current market situation for the reprocessing and reuse of SUDs was surveyed and analysed across 30 European countries.
The final report presents an overview of national decisions regarding the reprocessing of SUDs in the countries studied, certification processes for SUDs by notified bodies, the reprocessing of SUDs by manufacturers and health institutions, and the reuse of purchased reprocessed SUDs by health institutions. The document concludes with recommendations for the optimisation of Article 17 MDR in Europe.
Find out more about the study and report here.
MHRA shares guidance on combined review of new clinical trials for investigational medicinal products & combination devices
The UK’s MHRA has shared guidance regarding the combined review of clinical trials for investigational medicinal products and combination devices.
Combined review is the way in which research teams seek approval for new clinical trials for investigational medicinal products (CTIMPs) and combined medicine and device trials. Research teams make a single application using a new part of IRAS, which goes to both the MHRA and a research ethics committee (REC) simultaneously. The application also goes for study wide review, such as HRA and HCRW approval, if the study is to take place in the NHS or Northern Ireland HSC.
Read more about the Combined IMP device guidance here.
FDA issues draft guidance on 510(k) submissions for animal studies for dental bone grafting material devices
The FDA has recently announced the availability of the draft guidance “Animal Studies for Dental Bone Grafting Material Devices – Premarket Notification (510(k)) Submissions.”
Intended for manufacturers, the draft guidance document provides animal study design recommendations and animal study information to include to support 510(k) submissions for dental bone grafting material devices.
Read the guidance and submit comments by 28 May here.
eSTAR program extended to 513(g) requests
The electronic Submission Template and Resource (eSTAR) is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. As of the end of last month, eSTAR is now available for voluntary use for 513(g) requests for information to CDRH.
Find out more about eSTAR here.
Brazil’s regulator ANVISA announces RDC 830 / 2023 to become effective on 1 June
RDC 830 / 2023 will become effective on 1 June 2024, which requires manufacturers to perform a gap assessment between RDC 36 / 2015 and RDC 830 / 2023. In particular, manufacturers need to review the classification of their IVDs.
At the end of last month, ANVISA published several guidance documents to assist manufacturers with their readiness. See the links below for each document:
- Questions & Answers – RDC 830 of 2023
- RDC 830 / 2023 – Technical names – Change of risk class
- RDC 830 / 2023 – Technical names associated with more than one risk class
That concludes our April 2024 MedTech news roundup. Check back in May for more medical device news and updates.
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