Our May MedTech news includes timely updates from the US and EU, links to recent notable documents from the MDCG regarding clinical investigations, and resources from the FDA on patient-generated health data and Automated Endoscope Reprocessors respectively. Read on for more.
Top stories
Magnets in mobile phones & smart watches may affect pacemakers and implantables
Recent studies have shown that consumer electronic devices with high field strength magnets (such as mobile phones and smart watches), may cause certain implanted medical devices to switch to “magnet mode” and suspend normal operations until the magnet is moved away from the medical device. Find out more about the precautions recommended by the FDA here.
20th Notified Body designated under EU MDR while IVDR designations fall behind
Finland-born Eurofins Expert Services Oy is the latest European Notified Body to be designated under the Medical Devices Regulation (EU) 2017/745 (MDR) – making it in just before the MDR Date of Application deadline (May 26, 2021). Whilst this brings the total number of Notified Bodies designated under MDR to 20, there are still only four Notified Bodies designated under the EU In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).
This overview released by the European Commission (updated March 2021), shows that only 16 applications have been received for IVDR designation, of which two have been withdrawn because they were UK entities. Only one Notified Body is shown to be in the final stages of the pipeline for IVDR designation, calling into question the need to potentially postpone the IVDR Date of Application deadline currently set for May 2022.
New documents from the MDCG
Clinical investigation application/notification documents guidance
The MDCG has released a new document (MDCG 2021-08) that offers guidance for the clinical field by providing a selection of templates that can be used for the application/notification of clinical trials to authorities until the EUDAMED module for clinical investigation becomes fully functional. Access the document here.
MDR Q&A on medical device clinical investigation
An MDR Q&A document regarding medical device clinical investigation has also recently been released. Intended for sponsors of clinical investigations of medical devices conducted within the scope of the Regulation (EU) 2017/745 (MDR), the document covers general topics, modifications to clinical investigations, timeline considerations for clinical investigations, clinical investigation reports, and arrangements for the transitional period. Access the document here.
Resources from the FDA
Patient-generated health data (PGHD) throughout the total product life cycle of medical devices
Informative resources from the FDA’s recent webcast discussing patient-generated health data (PGHD) and its potential impact across the healthcare ecosystem are now available. The virtual public meeting took place earlier this month following recommendations from the FDA’s Patient Engagement Advisory Committee (PEAC) meeting in November 2018. Download the event materials here.
FDA’s evaluation of Automated Endoscope Reprocessors (AERs)
Automated Endoscope Reprocessors (AERs) are Class II devices cleared through the 510(k) premarket notification pathway. They are designed to kill microorganisms in or on reusable endoscopes by exposing their outside surfaces and interior channels to high level disinfectant or liquid chemical sterilant solutions. Take a look at the FDA’s evaluation of AERs on their information page here to find out more about these devices.
That concludes our May MedTech news. Check back in June for more updates.
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