The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions.
The organization, launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), sports an impressive array of members for an organization in its infancy: the US Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVISA), Health Canada, the European Union (EU), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and the Asian Harmonization Working Party (AHWP).
Other regulatory bodies, including those of China and Russia and the World Health Organization (WHO) are in the process of exploring membership as well, according to IMDRF, and currently have observer status. Other regulatory agencies will have the opportunity to join in the future, IMDRF has said.
IMDRF: The Basics
But what is the rationale for abandoning GHTF in favor of IMDRF, and how will its mission differ from that of the GHTF?
In a presentation at 2012 RAPS, regulatory professionals Jacqueline Minor, director of consumer affairs for the European Commission's DG SANCO, Mike Ward, manager of Health Canada's International Programs Division, and Kim Trautman, associate director of international affairs for FDA, said the organization is highly focused on accelerating the pace of regulatory harmonization.
Unlike GHTF, which was a blend of agency regulators and industry representatives, IMDRF relegates industry to a consultation role while keeping regulators in the drivers' seat. "After 20 years, time for a change," said Minor
This desire for accelerated change is written into the agency's mission, observed Trautman, speaking to the session by video link after an East Coast hurricane prevented her from attending in person. "The mission of the IMDRF is to strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety," she relayed, quoting its mission statement.
GHTF: Gone, but not Forgotten
Still, Minor said IMDRF is expecting to build-not ignore-upon the work of GHTF. The existing work of GHTF already covers most areas of medical device regulation, is widely used, readily available and may be updated as regulatory needs change, explained Minor. These goals are not set to change-just the pace of change itself and the way in which harmonization occurs.
But accomplishing those goals may be tough, regulators conceded. "There's a need to avoid 'lowest common denominator' outcomes," and to instead work with governments to change laws and regulations where necessary, argued Minor. This will require buy-in from legislators and government officials, which may prove difficult, especially without the added support of industry in all cases.
Industry expressed concerns in a subsequent session, noting that while the GHTF had its limitations-a lack of adoption in developing countries and a failure to achieve the level of harmonization once anticipated-those shouldn't overshadow its 20 years of successes or how it changed the conversation around regulatory harmonization in the medical device sector.
"Let's not throw the baby-GHTF-out with the bathwater," expressed one meeting participant.
Another participant expressed her concerns that as IMDRF focuses more on emerging markets-and in particular Asia-new countries' ability to innovate would be hindered by regulatory systems intended for developed countries.
Steward of GHTF Standardization?
Panel participants also raised the concern that IMDRF would be unable-or perhaps unwilling-to maintain GHTF's existing library of documents and its pace of work. Minor disagreed, saying her agency was committed to updating documents when necessary and maintaining the collection on a soon-to-be-unveiled website overhaul that would allow industry to comment on existing documents. "We are committed to update GHTF documents where necessary," Minor said.
"We have no intent to reinvent the wheel," added Ward. "Our expectation, especially with the pilot, is that we take feedback into account… to improve uptake." Ward added that the IMDRF intends to work with existing guidances in most cases, but will also be dialing in the degree of granularity in an attempt to achieve more use from the documents.
"Yes," quipped Jos Kraus, a member of industry. "Harmonization is a gift from god-but the devil is in the details."
The amount of access industry has during the development of IMDRF regulations relative to GHTF was a recurring point of concern for participants in the second session. There's a time for closed-door negotiations to occur to get things done quickly, said Shamiram Feinglass, vice president of global medical and regulatory affairs at Zimmer. But, she added, "At some point, the door needs to be open." In the absence of openness, said Paul Brooks, senior vice president for healthcare solutions at BSI, industry becomes suspicious.
Still, conceded Philippe Auclair, senior director for regulatory strategy and advocacy at Abbott, "[Industry] influence doesn't stop behind closed doors." The great challenge, conceded Ward, would be in determining what level of granularity is needed. "It's an art, not a science," he added.
Five Priority Areas
IMDRF regulators said they are looking into harmonization across the product lifecycle, from conceptualization all the way to postmarket surveillance. From those areas, Trautman and Minor said IMDRF has prioritized five work items in the short term: a review of the National Competent Authority Report (NCAR) system, a roadmap for the implementation of a unique device identification (UDI) system, a medical device single audit program (MDSAP), a common list of recognized standards, and a standardized submission process for regulated products (RPS).
The NCAR system, explained Trautman, "Facilitates the exchange of relevant post market safety information on medical devices with global distribution," allowing regulators to quickly push out corrective actions to various areas and affected stakeholders. The system is currently under review by EU regulators, and the proposal could come to include a possible expansion of the system.
Minor added that while achieving this harmonization would be good, it is necessary to recognize that regulators will need to be trained in data input and reciprocity. Currently, there's a jurisdictional imbalance, as some regulators enter an enormous amount of information, while others enter very little.
The UDI system seeks a globally harmonized approach building off earlier GHTF efforts, said Trautman. The system would allow regulators to trace a medical device back to its point of origin in the case of a safety issue or problem, as well as expedite a number of other important functions such as recalls. Several regulators have recently unveiled their own UDI plans, and regulators said a single "harmonized approach" could greatly benefit the system. Currently, there are dozens of UDI standards, and no one system is accepted across all five main regions (though 17 are accepted in four of the main five).
Going forward, IMDRF said it hopes not to generate a single, global standard, but rather recognize the benefits of a small handful in the hopes of generating a regulatory convergence toward those standards. Minor said that many details remain to be worked out, but hoped that IMDRF would have more answers within the next year.
Two other areas-recognized standards and RPS-promise to harmonize both the standards used by international regulatory bodies and the means by which they receive electronic document submissions from industry. Trautman said the group is already working on defining, "A common 'table of contents' for medical device regulatory submissions as a first step in defining a common data set." This project is being coordinated by Ward, who said they're aiming for common language and modular tables of contents for common device types.
Ward said the group is well along in the development of these standards, which are currently undergoing beta testing for fit for purpose, and are being assessed by Health Level 7, a standards development organization operating in the medical device sector. On the pharmaceutical side, observed Ward, standards took years to develop. "We don't have that sort of time for medical devices," he said, adding that they were incorporating lessons learned in the development of the electronic common technical document (eCTD).
Ward said he hopes to have a version released to the public soon, with comments due around August 2013. "We're not looking for standards of perfection with this document," he said. "Quite frankly, we don't even know what that looks like yet."
Third Party Auditing: The Future of Regulatory?
Trautman also said the forum was looking to develop a standard set of requirements for auditing organizations-something it is already well on its way toward. On 25 October 2012, IMDRF released a guideline defining the criteria regulators should use to recognize medical device auditing organizations performing work in their respective jurisdictions, including for conformity assessments and medical device surveillance. Trautman explained that the guideline will, "Complement the current ISO13485 revision process under which IMDRF seeks modifications to achieve a harmonized standard amongst its members."
Ward said the harmonization of auditing standards could not be underestimated, and called it the, "future of regulation."
"The regulatory investment here is very wise," argued Ward, noting that it would allow regulators to divert their limited resources elsewhere. Still, he said a number of issues will need to be worked out: How to audit consistently, which standards gets used, and how best to oversee third-party regulators across regulatory regions.
The proposed document, released by IMDRF's Medical Device Single Audit Program Working Group, is the first such document to be released by the organization, and is being coordinated by Trautman and is now available for comment on the organization's website.
Success: What Does it Look Like?
On the whole, many members of industry seemed to be cautiously optimistic regarding the fortunes and opportunities for IMDRF.
Success for the agency seemed to be defined by all parties-both industry and regulators-as greater adoption of harmonized regulations and guidance relative to GHTF.
Still, Feinglass concluded her remarks by saying that, "If IMDRF is to succeed, it need to do so quickly. If it is to fail, it needs to do so even more quickly. We don't have the time to wait for it to fail slowly."
Success, too, may ultimately involve the organization's global reach. Minor said that both Russia and China had signaled their intent to join the organization, though Russia seemed more available to do so. China, she said, still required more internal approval in order to sign onto the forum.