Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland, and Asia. Read on for this month’s headlines.
News & updates from the US & Canada
Cybersecurity vulnerabilities with BlackBerry QNX RTOS may pose risk to medical devices
Vulnerabilities with BlackBerry’s QNX Real Time Operating System (RTOS) version 6.5 Service Pack 1 and earlier may introduce risks for certain medical devices and manufacturing equipment. Whilst the FDA is not aware of any confirmed adverse events related to these vulnerabilities, they have provided information for manufacturers on steps to take to mitigate potential cybersecurity issues. Find out more here.
FDA issues new EUA for COVID-19 diagnostic tests
This month the FDA has published information about two newly authorised SARS-CoV-2 molecular diagnostic tests. See the full list of approved COVID-19 diagnostic tests here.
Health Canada issues requirements for UV light-emitting products with COVID-19 claims
Health Canada has published a notice on the regulatory classification of UV light-emitting decontamination products that make COVID-19 claims, such as those used to disinfect rooms, environmental surfaces and household items. Information on the applicable pathways for market authorisation is also provided. Find out more about the regulatory requirements here.
FDA calls for proposals on tools for Medical Device Development Program
The National Cancer Institute (NCI) is collaborating with the FDA’s Centre for Devices and Radiological Health (CDRH) to support small businesses in their development of innovative medical device development tools (MDDTs). On Tuesday, 24 August from 2pm – 3pm, ET, NCI and CDRH are holding a joint informational webinar to discuss two funding opportunities regarding:
- Quantitative Biomarkers as Medical Device Development Tools for Cancer
- Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies
Details regarding these funding opportunities, MDDT program requirements, and small business eligibility criteria will be covered during the webinar. Find out more here.
Guidance & position papers from Europe & Switzerland
EU-Swiss MRA latest: EU market access under MDR transitional provisions
With the EU and Switzerland being unable to finalise an updated MRA to cover all aspects of the MDR, a number of questions remain on how to proceed with the implementation of article 120 of the MDR for those manufacturers who rely on Switzerland to access the EU market.
Swiss MedTech has published a useful document that focusses on the transitional provisions, and seeks to fill the information gap. Find out more here.
MDCG issues guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
MDCG has published a guidance document concerning the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) in the context of conformity assessment under either
Directive 98/79/EC or Regulation (EU) 2017/746. The guidance covers devices that detect or quantify SARS-CoV-2 nucleic acid, antigens and antibodies against SARS-CoV-2. Read more here.
MDCG publishes instructions for generating CIV-IDs for MDR clinical investigations
MDCG has issued instructions for generating a Union-wide unique single identification number for clinical investigations under Regulation (EU) 2017 / 745 (MDR). The required steps involve searching for / generating a clinical investigation ID, entering the mandatory details of the related clinical investigation, and confirming the clinical investigation. For the full instructions, click here.
Announcements from Asia
Japan: PMDA aims for closer communication with patients
Japan’s PMDA has communicated their increased effort regarding communication with patients. Their recent announcement introduces three key actions that aim to improve patient satisfaction including; website enhancement, relief services for adverse drug reactions, and a patient centricity working group. Read more here.
China: Drug approval certificate no longer required for combination product registration
China’s NMPA has issued a “Notice Regarding Drug-Device Combination Products Registration” to address concerns around the requirement for drug approval certificates for combination products from both the product’s original country, and China. Find out more here.
South Korea: MFDS plans Medical Devices Act amendments
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced their plans to implement several amendments to the country’s Medical Devices Act in 2022, whilst also expanding its list of devices eligible for electronic instructions for use (eIFUs). Read more about the Medical Devices Act amendments here and see the list of devices eligible for eIFUs here.
That concludes our August MedTech news. Check back in September for more updates.
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