Skip to main content
Premium Trial:

Request an Annual Quote

International Regulatory Group Proposes Principles for Evaluating Safety, Performance of Diagnostics


NEW YORK (360Dx) – The International Medical Device Regulators Forum, a group of regulatory authorities from around the world, has proposed a new guidance for harmonizing the procedures for assessing medical devices, including in vitro diagnostics.

The 34-page document, entitled "Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices," was released last month for public feedback. The public consultation period will close on April 18.

According to the IMDFR, the purpose of the guidance is to coordinate the protocols used to assess whether a medical device conforms to the different regulations of various jurisdictions. The group maintained that worldwide adoption of the principles will offer "significant benefits" by lessening the costs of gaining regulatory compliance and "giving patients earlier access to new technologies and treatments."

"The intention of the IMDRF guidance on essential principles is to outline high-level design and manufacturing criteria that, when met, ensure the safety and performance of medical devices and IVD medical devices," said Melissa Torres, associate director for international affairs at the US Food and Drug Administration's Center for Devices and Radiological Health.

Torres noted that the FDA participated in drawing up the document and is the IMDRF working group chair for this specific effort.

Regulators from Australia, Brazil, Canada, China, the EU, Russia, Japan, Singapore, and South Korea, also participate in IMDRF. They established the forum, which meets several times a year, in 2011. Its goal is to harmonize methods across jurisdictions for assessing conformity with safety and performance requirements.

Since the new guidance is in a consultation period, Torres declined to outline the FDA's position on the guidance, or how it might impact US procedures for assessing medical devices, including IVDs. In a presentation in Vancouver, Canada last March, however, Torres said that the ultimate goal of the new guidance was to develop a medical device single review program that would "allow for a single regulatory premarket review to satisfy the needs of multiple regulatory jurisdictions."

The proposed program is modeled on the Medical Device Single Audit Program (MDSAP), which the IMDRF created following its first meeting in Singapore in 2012. MDSAP allows an approved auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the requirements of participating authorities.

Countries that participate in MDSAP, include Australia, Brazil Canada, and Japan. The US also participated in the program as part of a pilot study from 2014 to 2016.

At the Vancouver meeting, Torres said that the development of a similar Medical Device Single Review Program would not only help achieve regulatory harmonization, but would promote the "consistency, predictability, transparency, and quality" of regulatory programs, and would reduce regulatory redundancies, ultimately resulting in new tests reaching patients faster.

According to Torres, once the consultation period closes in April, the working group intends to address feedback and produce a final document for consideration during its September management committee meeting in Beijing.

If finalized and approved by the IMDRF management committee, the document could be published by October, she said. Implementation of the guidance would be up to each jurisdiction and wouldn’t happen until the document has been finalized, Torres noted.

The document outlines principles applicable to medical devices and IVDs. These include principles governing risk reduction, labeling and instructions. The guidance also contains a special subsection of principles applicable only to IVDs. These govern both analytical and performance characteristics, as well as the chemical, physical, and biological properties of the IVDs under assessment.

In terms of analytical performance, the document cites the traceability of calibrators and controls, the accuracy of measurement, limit of detection, analytical sensitivity, the measuring interval, and the stability of the specimen as characteristics for assessment. Clinical performance meantime may be assessed on the basis of diagnostic and clinical sensitivity and specificity, positive and negative predictive values, likelihood ratios, and expected values in normal and affected populations. 

With regards to chemical, physical and biological properties, the guidance notes that makers of IVDs should pay attention to any incompatibility between the materials used and the specimens, analytes, or markers to be detected, to prevent any possible impairment.  

The document also includes an Annex providing an "overarching guidance" for meeting the outlined essential principles. The IMDRF noted in the Annex that depending on the specific medical device or IVD, "additional product specific standards may need to be used." It also stated that the requirements of particular regulatory authorities must also be considered in following the guidance.

While the guidelines are not binding, at least some IMDRF members have expressed support for it.

Renelle Briand, a spokesperson for Health Canada, said that harmonizing the premarket review process, as outlined in the guidance, might result in "faster access to approved medical devices for Canadians." Briand noted that once the document is finalized, it is still up to each participating regulator to assess how to implement the guidance within its regulatory framework.

Adriana Platona, first assistant secretary at Australia's Therapeutic Goods Administration, which regulates medical devices, said that the country already has a set of essential principles as part of its legislative requirements for medical devices. "The value of this project is to achieve greater harmonization with the US, should the FDA also choose to adopt the essential principles approach," she said.

An EU spokesperson said the European Commission is "supporting the document," but declined further comment during the consultation period.

Observers familiar with the new guidance said that, if adopted, it will succeed in accelerating and harmonizing regulation for medical devices on a global level.

Joseph Ferrara, CEO of Boston Healthcare, an international life sciences consulting firm headquartered in Boston, said that reducing regulatory duplication and streamlining the path to market for new technologies will "inevitably lead to more well-defined pathways for reimbursement and commercialization," as well as encourage greater innovation.

"It will support both the manufacturers by more efficient development of new products and the patients by quicker and safer access to innovative medical devices and diagnostic," Ferrara said. However, he warned that should all IMDRF participants adopt the Essential Principles approach described in the new guidance, it wouldn't lead to complete concordance in regulation globally.

"Peculiarities between countries won't be leveled out completely," said Ferrara. "This means manufacturers will still need to secure in-market experts to master the approval and market access pathways."