Over the past several months there have been increasing efforts by regulators to ensure there are clear rules and procedures in place for medical device clinical research. Seeing device-specific measures and guidelines popping up around the globe is good news for an industry that has long been plagued with the expectation that medical devices should fit into a regulatory system designed for pharmaceuticals.
Below are highlights of some recent regulatory developments concerning medical device clinical investigations.
- At this week’s meeting of the International Medical Device Regulators Forum (IMDRF), the Global Medical Technology Alliance is scheduled to present on a proposed a new work item: harmonisation of good clinical practices.
- The European Union is working on revising its legislation governing medical devices and in vitro diagnostics, which will cover clinical investigation of these products, among other provisions. The European Forum for Good Clinical Practice (EFGCP) and MedTech Europe, which represents the European medical technology industry, are working together to make sure ethical and quality issues are addressed in this context. MedTech Europe CEO Serge Bernasconi said: “There’s a growing understanding in the healthcare policy arena that we can’t just copy and paste the pharmaceutical approach to clinical standards into EU legislation on medical devices and in vitro diagnostics.”
- In Germany, BfArM issued a notice on 29 July about changes to the country’s regulation on medical device clinical trials regulation.
- In the Netherlands, the Dutch Royal Academy of Sciences published a report entitled Evaluation of New Technology in Health Care, which discusses clinical evidence for medical devices in the context of future EU policy.
- The UK Health Research Authority has published guidance on the mandatory registration of medical device trials.
- The Irish Health Products Regulatory Authority on 15 August released guidance for manufacturers and sponsors on device clinical investigations.
- Portugal’s Infarmed has announced the adoption of a new clinical research law (No 21/2014), effective 16 June 2014, covering devices. (Regulations expected by year-end.)
- Switzerland’s new law on clinical research, which covers medical devices, came into effect on 1 January 2014. Swissmedic recently updated its information sheet on clinical trials of medical devices and published guidance on the obligations of foreign sponsors’ designated representatives that are involved in clinical trials of therapeutic products in Switzerland.
- Turkey’s Pharmaceuticals and Medical Devices Agency issued a notice about a new regulation on device trials, which came into effect on 6 September.
- The FDA has published a number of draft and final guidance documents:
- Brazil’s regulator, ANVISA, launched a consultation on a proposed regulation governing medical device clinical trials. Earlier this year, it issued a technical note clarifying the procedures for approval and notification of device clinical trials.
- The Chinese FDA announced a new clinical trial approval process for some high-risk Class III devices such as pacemakers and artificial heart valves, effective from 1 October 2014. These medical devices must acquire the CFDA approval before clinical trials start. Certain Class III medical device accessories are also being exempted from clinical trial approval requirements. The list of exempted products (in Chinese) can be found here.
- In Russia, Roszdravnadzor announced new clinical trial requirements for medical products.