Our May 2023 MedTech news roundup includes Swiss Medtech’s position paper on medical device procurement for the Swiss population, Swissmedic’s hospital inspection findings, and updated guidance from the MDCG regarding MDR transitional provisions for legacy devices. Guidance from the EU Commission on clinical investigation report summaries, an update from the FDA on EUA next steps post COVID-19 public health emergency, and medical device regulations amendment proposals from Health Canada also feature. Read on for more…
Swiss Medtech urges flexibility for medical devices procurement
Switzerland relies on the import of medical devices to meet the requirements of its population. But currently, only products complying with European medical device regulations bearing the CE mark are permitted in Switzerland.
In November last year, Parliament passed a motion for “more room for manoeuvre in the procurement of medical devices for the care of the Swiss population” which, when implemented, would see Switzerland recognise medical devices from non-European regulatory systems with comparably strict requirements – in particular those approved for use in the USA by the FDA.
Swiss Medtech’s recent position paper outlines the organisation’s expectation for the Federal Council to implement Parliament’s mandate swiftly and pragmatically in order to guarantee a sustainable and sufficient supply of safe medical products for the Swiss people. Read the full paper here.
Swissmedic report emphasises need for improvement in Swiss hospitals
In accordance with its legally defined mandate, Swissmedic monitors the reprocessing, maintenance, and vigilance of medical devices in hospitals. This month, Swissmedic released its 2021 / 2022 annual report on hospital inspections which details the selection of hospitals, the number of deviations observed, and the key deficiencies in the inspected areas.
The inspection findings highlighted considerable need for improvement and investment in Swiss hospitals in the areas of technical quality management, basic and further training of the reprocessing personnel and the infrastructure of the reprocessing departments. To read the full report, see here.
MDCG 2020-3 guidance on MDR transitional provisions for legacy devices updated
Intended for manufacturers of legacy devices, the EU’s MDCG has shared updated guidance on significant changes regarding the transitional provision under Article 120 of the MDR concerning devices covered by certificates according to MDD or AIMDD.
This first revision of MDCG 2020-3 considers the experience gained with the application of the original version so far, and is aligned with the equivalent guidance for IVDs, MDCG 2022-6 of May 2022 and adjusted to Regulation (EU) 2023/607. You can read the updated guidance here.
EU Commission publishes guidance on clinical investigation report summary
The EU Commission has published guidance on the content and structure of the clinical investigation report summary.
The guidance aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in a format that’s easily understandable and uses terms that are comprehensible by intended users of the medical device. Read the guidance here.
FDA shares next steps for EUAs post COVID-19 public health emergency
The COVID-19 public health emergency declared under section 319 of the Public Health Service (PHS) Act expired earlier this month on 11 May.
The FDA has communicated that the end of the public health emergency does not impact its ability to authorise devices, including tests, for emergency use. Existing emergency use authorisations (EUAs) for devices remain in effect, and the FDA may continue to issue new EUAs going forward while the EUA declarations under section 564 of the FD&C Act are in effect and when the criteria for issuance of an EUA are met.
To find out more about what happens to EUAs when a public health emergency ends, take a look at the FDA’s Q&A here.
Antimicrobial resistance and medical devices information from the FDA
Antimicrobial agents, such as antibiotics, are drugs that work by killing or slowing the growth of targeted microorganisms responsible for causing infections. Antimicrobial susceptibility tests (ASTs) are medical devices used in clinical laboratories to determine which antibiotics are likely to be effective against a particular microorganism causing an infection.
All AST devices sold in the US for use in clinical laboratories must be reviewed and cleared by the FDA’s CDRH prior to marketing. This page from the FDA provides information on the global impact of antimicrobial resistance, antimicrobial susceptibility testing, CDRH’s role as reviewer, and the FDA’s involvement in national antimicrobial resistance activities.
FDA updates Catalog of Regulatory Science Tools
The Catalog of Regulatory Science Tools provides a peer-reviewed resource for medical device companies to use when standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. On 4 May, the FDA updated the Catalog to add three new tools and update five existing tools.
The new tools include mock spine cage designs, lumbar integrated fixation devices best practices, and an in silico breast imaging pipeline. The updated tools involve endoscope geometric distortion, infrared thermographs, methods for estimating the likelihood of wireless coexistence, a modified dot-blot method to evaluate PPE, and verification test problems for cardiac electrophysiology modelling software. Find out more about the tools here.
FDA shares tips on cybersecurity incident preparedness
On 1 May the FDA launched a video that shares tips for health care facilities regarding cybersecurity incident preparedness and response. The video focuses on how to prepare for a cybersecurity event and how to help ensure patient safety during a prolonged cybersecurity event. You can access the video here.
MDSAP QMS procedures | Latest update
The MDSAP Regulatory Authority Quality Management System (QMS) procedures provide a transparent overview on how participating regulatory authorities are working together to ensure a quality program.
This month, the Control of Quality Records Procedure was updated. For access to the range of MDSAP procedures, see here, and to find out more about the MDSAP program check out our topical article.
Health Canada proposes amendments to Medical Devices Regulations
Health Canada is proposing amendments to its Medical Devices Regulations to modernise the frameworks for establishment licences and recalls.
The proposals include:
- updating the definition for “recall” to include recalls ordered by the Minister
- establishing a regulatory framework for recalls of medical devices ordered by the Minister
- clarifying industry’s reporting and record-keeping obligations for recalls that they initiate
- aligning the reporting of low-risk medical device recalls with international regulatory agencies
- modernising the medical device establishment licence (MDEL) application requirements to reflect current practices
- giving the Minister the ability to issue terms and conditions on an MDEL to mitigate risks to health and safety, and strategically target non-compliance
Read more on the amendments here.
That concludes our May 2023 MedTech news roundup. Check back in June for more medical device news and updates.
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