This month’s roundup covers tackling medical device supply shortages in Switzerland, advice on direct procurement of foreign medical devices into Switzerland, and updates from the EU Commission and MDCG on Data Act adoption and transitional provisions surveillance respectively. Recent news from the FDA, Health Canada, and China’s NMPA also features. Read on for more…
Updates & guidance from Switzerland & Europe
Tackling imminent supply deficits for medical devices in Switzerland
There is growing uncertainty that sufficient medical devices will be available to supply the Swiss population in the coming years.
Andrea Schütz and Bernhard Bichsel have recently published an article that shows healthcare institutions and professionals the legal instruments available to them to prevent supply shortages and to make concrete recommendations for action.
The publication also serves as an appeal to politicians and health authorities to proactively address the issue of supply shortages of medical devices and IVDs. Read the full article here.
Swiss Medtech issues guidance on direct procurement of medical devices
Swiss Medtech has recently issued guidance on the direct procurement of foreign medical devices by healthcare professionals in Switzerland.
The Medical Devices Ordinance allows professionals to procure devices directly from abroad for use without placing them on the market. In the case of direct procurement, individual professionals and health institutions automatically assume full functional responsibility – meaning that no Swiss economic operator is responsible for any procedural or safety-related issues, and the readiness for delivery depends exclusively on the foreign supplier.
The direct procurement of devices from abroad is therefore associated with considerable risks related to supply and liability, and so Swiss Medtech recommends that healthcare professionals and health facilities should always obtain their devices from Swiss manufacturers and/or distributors and only resort to direct procurement from a foreign supplier as an emergency option. Find out more in the recent guidance here.
EU Commission adopts Data Act for fair and innovative data economy
At the end of last month, the European Commission adopted a legislative proposal for a Regulation on harmonized rules regarding fair access to and use of data.
The Data Act aims to ensure fairness in the digital environment, stimulate the data market, and increase data accessibility. The initiative includes measures that will allow users of connected devices (including medical devices) to gain access to their generated data, and that will grant public bodies access to, and use of, data held by the private sectors in exceptional circumstances such as health emergencies. The Regulation also seeks to prevent abuse of contractual imbalances within data sharing contracts. You can read more about the proposal here.
New guidance from MDCG on transitional provisions surveillance
The MDCG has published new guidance on the appropriate surveillance regarding the transitional provisions under MDR.
MDCG 2022-4 outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120 (3) of the EU MDR. To clarify elements to be verified by notified bodies, the guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system. You can access the guidance document here.
The latest from the US & Canada
FDA’s CDRH releases final guidance on Appeals Processes
The Centre for Devices and Radiological Health (CDRH) has published final guidance that describes the processes available to outside stakeholders to request an additional review of decisions made by CDRH employees.
This release means that individuals outside of the FDA who disagree with a decision or action taken by CDRH and wish to have it reconsidered, can now choose from several processes for resolution including petitions, hearings, and requests for a supervisory review of an action. The document provides general information about each process, as well as guidance on how to submit review requests. Find out more here.
FDA shares FAQs on Quality System Regulation Amendments Proposed Rule
On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation. The proposal seeks to align the QS Regulation more closely with the international consensus standard for Quality Management Systems for medical devices that is used by many other regulatory authorities around the world. The proposal primarily involves the incorporation of a reference to the 2016 edition of ISO 13485.
The FDA has shared a list of frequently asked questions to help clarify the details of the proposed rule. Take a look here to find out more.
Health Canada updates regulations to address medical device shortages
As of March 2, 2022, amendments to the Canadian MDR have come into force which allow for the exceptional importation and sale of medical devices to help address shortages in Canada. The amendments will help Health Canada to track, prevent, and mitigate medical device deficits.
Health Canada has published a draft guidance that supports these new amendments, which you can access here.
News from China
China’s NMPA releases digital health guidelines
On March 9, 2022, the NMPA released three guidelines in an effort to regulate and support the rapid developments in digital health. The guidelines cover:
- Artificial Intelligence in Medical Devices Registration
- Medical Device Software Registration
- Medical Device Cybersecurity
Referencing FDA and IMDRF guidance, these guidelines aim to harmonize with international standards, with a focus on risk factors and product total life cycle management. You can purchase an English copy of the three guidelines here.
That concludes our March MedTech news. Check back in April for more updates.
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