IMDRF Takes Up Cybersecurity, Premarket Reviews, Personalized Device Pathways

The International Medical Device Regulators Forum (IMDRF) has begun wading into harmonizing the premarket review process, regulatory pathways for personalized devices and cybersecurity, following the management committee meeting last week.
 
“I continue to be impressed by the great work and enthusiasm by the IMDRF member countries,” Jeff Shuren, director at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told Focus at the MedTech Conference Wednesday. “I’m looking forward to the continued collaboration.”
 
Shuren, who is also head of delegation to the IMDRF management committee, briefed attendees at the AdvaMed conference on the outcome statement from the last gathering in Beijing, where it was also decided that Russia will replace China as IMDRF chair next year.
 
Cybersecurity
 
The cybersecurity new work item will be jointly led by FDA and Health Canada per the proposal presented by the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) at the committee hearing, as previously reported by Focus. 

The goals of the first work product approved will be a guidance that will define cybersecurity in relative terms, including information security, privacy, exploit, theft, vulnerability and harm, among other critical terms. It will also seek to clarify cybersecurity as a shared responsibility across all stakeholders, according to Shuren.
 
The two co-chairs have already been “thinking through a lot of these questions in most jurisdictions so there’s a lot of activity going on in that space,” making them “natural leads to chair that effort,” DITTA chair Patrick Hope previously told Focus. The new work item approval resulted in the addition of the eighth IMDRF working group. 
 
DITTA also offered a chart for transparency around the steps the various regulatory authorities are taking for implementation of IMDRF documents during the meeting.
 
“We agree we have to be more transparent about what we’re doing around implementation,” Shuren said. “We may not use that chart but we will provide feedback, ‘Here's what we’re doing on implementation,’ to keep industry in the loop.”

Approved revisions to the IMDRF management committee standard operating procedure on submitting a new work item proposal extension now requires these to be submitted at least ten weeks in advance so that it can be evaluated prior to presenting it at a meeting to facilitate the decision-making process.
 
Regulatory Pathways for Personalized Devices
 
The IMDRF management committee approved the personalized medical devices definitions final document developed by Australia’s Therapeutic Goods Administration.
 
The final document will provide an overarching definition on personalized medical devices and more specific definitions for three types of such devices—custom-made devices, patient-matched devices and adaptable devices.
 
It will be released in the upcoming “days or weeks,” along with the approved final IMDRF documents on the essential principles of safety and performance and optimizing standards for regulatory use, according to Shuren.
 
The personalized medical devices working group is now going to take on regulatory pathways for personalized medical devices and look to harmonize these by building off of the final document on definitions. 

Premarket Reviews

Now, the global regulatory review practices working group is going to take on medical device premarket review organization recognition. This will allow for global harmonization of how these devices are recognized by entities that perform premarket reviews. Singapore will co-chair this effort with US FDA, Shuren added. 

The move to take up a premarket review work item comes after Shuren indicated earlier this month that CDRH had been entertaining the creation of a medical device single review program to the IMDRF management committee, as previously reported by Focus.
 
Shuren made note of the pending decision by the management committee on what now has an official nickname—MDSRP—at an earlier conference session on global best regulatory practices. As of Monday, IMDRF has only agreed to put the building blocks in place, such as with finalized guidelines on safety and performance principles.
 
The finishing touches to the outcome meeting statement were still being made Tuesday and it has not yet been published on the IMDRF website.
 
MDSRP could have a similar implementation structure to that of the Medical Device Single Audit Program in that it could be first piloted in a some of the jurisdictions, argued Shuren. It would differ, however, in that its basis is currently expected to be either the IMDRF’s Table of Contents (ToC) structure or an improved version of it.
 
The various IMDRF jurisdictions are still looking to what they can do to implement the ToC structure, with about half moving forward and the other half still exploring, said Shuren.
 
He also noted that three countries will start accepting the ToC, at least to an extent, next year. These include Health Canada, which will accept ToC as its preferred format beginning on 1 April 2019. More details to come on the plans for ToC adoption in China and in the US, which intends to accept ToC as an option for premarket applications.
 
“Our goal is not to mandate ToC but to have it as an option at least for some submissions across all of our jurisdictions,” Shuren said.
 
Upcoming IMDRF management meetings
 
The ToC is currently being evaluated under a pilot program in Canada and the results will be presented during an IMDRF management committee teleconference in January for a potential final endorsement if the structure is deemed ready for such a move. The working group will otherwise try again during the face-to-face meeting in March, Shuren said.
 
Other consultations that will also be presented at the March meeting are set to close on 12 October and relate to adverse event terminology and essential labeling principles.
 
As part of the efforts of the US-led good regulatory review practices working group, CDRH also now has liaisons with ISO TC 210 and IEC TC 62. "What you're going to see is IMDRF coming together as an organization and all of the participating countries saying with one voice: 'You need to take our issues into account or we're not going to recognize your standards' and we need help from industry to echo that message," Shuren said.
 
The standard development organizations plan to conduct a survey of the IMDRF members, which also include the EU, Brazil, Russia, Australia, Japan and South Korea, to understand how standards are used by regulatory authorities. “Then likely we will move forward with a new work item to develop a harmonized approach on the recognition and use of standards,” Shuren said. “This is incredibly important to the IMDRF members.”
 
Yet another item of discussion set for March involves the first new work item proposed by China and approved during the IMDRF meeting earlier this year on clinical evaluation.

The clinical evaluation working group plans to issue a set of consultations focused on three areas aimed at reducing redundant clinical trials. These include leveraging existing data, decision-making principles for whether or not to conduct a clinical trial and the acceptance of overseas clinical data.  
 
Further, the unique device identification (UDI) application guide working group, chaired by Japan, have developed three separate documents for ensuring consistency across jurisdictions developing such as system, providing a crosswalk to monitor different implementation approaches and reporting UDI data in electronic health records.