MedTech news April 2024 MedTech news

MedTech news roundup April 2024

Posted on by Congenius

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Guidance from the UK’s MHRA on the combined review of clinical trials for IMPs and combination devices, draft guidance from the FDA on 510(k) submissions for animal studies for dental bone grafting material devices, and the latest from Brazil’s ANVISA on RDC 830 / 2023 also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.

Access the guidance here.

MDCG issues safety reporting guidance for IVD medical devices

MedTech news April 2024

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

MedTech news April 2024

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:

That concludes our April 2024 MedTech news roundup. Check back in May for more medical device news and updates.

Found this useful? To receive our MedTech news direct to your inbox, you can subscribe to our monthly Knowledge update.

Related News & Knowledge


Get in touch

If you have a challenge that you think we could help with, please feel free to get in touch in a way that suits you best. We look forward to speaking with you!

Get in touch


a demo

Find out more about QMgeniuS by requesting a demo.

Simply fill out your details and click “Request a demo", then a member of the team will get back to you shortly.

Alternatively, feel free to give us a call on +41 44 741 04 04 to start the conversation. We look forward to hearing from you!


    Subscribe to our
    monthly knowledge update

    Stay informed and up to date with the latest industry news delivered direct to your inbox. You can tailor your preferences to prioritise what you'd like to hear about each month; be it MedTech news headlines, fact sheet resources on the latest regulations or longer articles covering timely topics across the wider MedTech industry.

    By clicking subscribe, you are signing up to receive a monthly newsletter from us containing MedTech news, industry insights and more from Congenius. Subscribing also gives you full access to all topical content on our website. For information on how your data is managed, see our privacy policy.