Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

GHTF Proposes Standardized Approach to QMS Nonconformity Issues

The Global Harmonization Task Force (GHTF) has proposed establishing a standardized grading system for quality management system (QMS) nonconformities, along with a standardized Regulatory Audit Information Exchange Form to provide more consistent ISO 13485:2003 audit data for use between medical device market regulators.

The GHTF’s proposed Regulatory Audit Information Exchange Form includes three parts. First, a list of nonconformities from a QMS audit report is necessary to explain each nonconformity reported. (The nonconformities included in this list should match those listed in the manufacturer’s original audit report.)

Second, details of a Nonconformity Grading System should be included showing how the manufacturer’s final nonconformity grade was determined.

Third, nonconformities pertaining to country-specific medical device regulatory requirements outside the scope of ISO 13485 should be identified in order to provide regulators with a more complete picture of a particular manager’s general state of compliance.

The GHTF’s proposed Nonconformity Grading System entails a two-step approach: Step 1, involving a Nonconformity Classification Matrix to make initial evaluations, and Step 2, which applies escalation rules in order to determine a final grade.

“Currently, the significance of a nonconformity related to a medical device manufacturer’s Quality Management System (QMS) may vary between regulatory authorities and auditing organizations,” the GHTF proposal states. “All parties will benefit through the use of a standardized and transparent grading system of QMS nonconformities to communicate the findings of a regulatory audit, building the confidence necessary for the potential mutual acceptance of the results of a regulatory audit.”

Even though no current standard QMS regulation exists across medical device markets—even among the GHTF founding members, ISO 13485 is not uniformly required—establishing a single method for evaluating quality system nonconformities could lead to a more effective global regulatory approach to medical device quality systems.

Markets: WorldwideTags: GHTF, Global Harmonization Task Force, nonconformity, QMS, quality system

Author: Stewart EisenhartDate: May 1, 2012

Device Classification Guidance Issued by GHTF

As it transforms into a new organization, the Global Harmonization Task Force (GHTF) continues to issue guidances likely to influence major medical device regulators worldwide.

In early October, the GHTF’s Study Group 1 published guidance on medical device classification principles. The guidance recommends a four-class system for medical devices based on intended use, and that should determine conformity assessment pathways for individual devices.

The guidance provides 17 rules for classification of devices, as well as decision trees demonstrating how to apply the rules.

Structural recommendations of the GHTF’s classification rules include:

A four-tier system with Class A representing lowest-hazard devices and Class D the highest-hazard devices
Classification determinations should be based on a device’s potential to harm a patient, its intended use and also the technology it uses
Classification rules should be able to accommodate future technology developments
Manufacturers should document their justifications for assigning their devices to Class A, B, C or D

In order to determine device classification, manufacturers should document their products’ intended uses and examine whether their devices fall under national rules that may impact classification in particular markets.

Markets: WorldwideTags: conformity assessment, GHTF, Global Harmonization Task Force, medical device, medical device classification

Author: Stewart EisenhartDate: November 11, 2011

GHTF Publishes Unique Device Identification Guidance for Regulators

The Global Harmonization Task Force (GHTF) has issued final guidance on developing a global Unique Device Identification (UDI) system for medical devices.

The GHTF lays out fundamental concepts any UDI system established by a medical device regulator should follow in order to ultimately reach a truly worldwide framework:

UDI should be based on global standards
A UDI used for a device in one market should meet the requirements of any other market authority in the world
National or local identification numbers cannot be used as UDI numbers
No regulatory authority should specify how to modify UDI standards
Core elements of the UDI Database are not to be modified
Data Exchanges on the UDI Database should be conducted using HL7 SPL

Establishing a global UDI system, argues the GHTF, would enhance the traceability of devices throughout their distributions, as well as the ability to identify devices involved in adverse events and documentation and data capture of devices.

The GHTF guidance emphasizes that in order for a harmonized, global UDI framework to properly take effect, any medical device regulator implementing its own system will need to adhere to these recommendations.

Markets: WorldwideTags: GHTF, Global Harmonization Task Force, UDI, Unique Device Indentification

Author: Stewart EisenhartDate: September 29, 2011

New Adverse Event Reporting Guidelines from GHTF

The Global Harmonization Task Force’s (GHTF) has issued guidance establishing a uniform, global system for adverse event reporting during pre-market clinical investigations of medical devices.

The GHTF’s proposed model, devised by the organization’s Study Group 5 (SG 5), identifies types of adverse events stemming from clinical investigations that sponsors should report to National Competent Authorities. The SG 5 recommends that all participating countries should align their pre-market adverse event reporting requirements with the new GHTF model as they amend or develop their own regulatory systems.

Events that the GHTF guidance contends must be reported include all serious health threats, as well as device deficiencies that could cause serious adverse events. In questionable instances, sponsors should err on the side of caution and report to their appropriate authorities.

In terms of reporting timelines, the GHTF recommends that any adverse event posing a serious health threat be reported to a National Competent Authority within 48 hours. Within 10 days, sponsors should report unanticipated serious adverse device effects as well as serious adverse events resulting in death or serious injury. Finally, the GHTF recommends a 30-day deadline for reporting adverse events resulting in hospitalization or surgery, as well as device deficiencies that could have caused serious adverse events had they not been corrected or accounted for in time.

Markets: WorldwideTags: adverse event, clinical investigation, GHTF, Global Harmonization Task Force

Author: Stewart EisenhartDate: July 12, 2011

GHTF Issues Final Guidance on Medical Device Regulatory Model

The Global Harmonization Task Force (GHTF) has published final guidance advocating global convergence of medical device industry regulation as the organization reforms itself into a new entity with reduced industry influence.

The document, The GHTF Regulatory Model, compiles recommendations of its five study groups on pre-market evaluation, post-market surveillance and vigilance, quality systems, auditing and clinical safety and performance. The GHTF intends for the document to be used by regulators, Conformity Assessment Bodies and manufacturers; the roles and responsibilities of National Competent Authorities, Conformity Assessment Bodies and manufacturers are all spelled out, as well.

Key elements of the GHTF regulatory model, according to the guidance, are risk-based pre-market controls, a post-market vigilance and surveillance system, a quality and risk management system encompassing a device’s life cycle, and a regulatory audit process to assess conformity.

Aspects of the model still under development at the GHTF include unique device identifiers, combination products, definitions and classifications of field safety corrective actions, and change management.

The GHTF Steering Committee published this latest guidance in order to integrate the organization’s existing documents, as well as related materials such as international standards, regulatory model components not yet developed, and GHTF documents currently under development.

An integrated document covering all aspects of a global medical device regulatory model was first proposed in 2008 at a GHTF steering committee meeting in Malaysia.

Markets: WorldwideTags: GHTF, Global Harmonization Task Force, medical device

Author: Stewart EisenhartDate: May 9, 2011

GHTF Moves to Disband

The Global Harmonization Task Force (GHTF), founded in 1992 to promote uniformity across medical device regulatory regimes, will soon cease to exist according to the Medical Technology Association (MTA) of Australia.

Regulators from the US, EU, Japan, Australia and Canada, the GHTF’s founding members, elected to dissolve the group in order to form a new entity consisting solely of regulators; in its current iteration, the GHTF allows equal standing for medical device industry associations. The proposed new organization will purportedly seek feedback from medical device industry advocates, health care representatives and consumer groups as part of ongoing regulatory harmonization pursuits.

The GHTF will continue in its current form at least until its next meeting in May, according to the MTA.

Markets: Australia, Canada, Europe, Japan, USACategories: Regulatory ComplianceTags: Australia, canada, EU, GHTF, Global Harmonization Task Force, Japan, US

Author: Stewart EisenhartDate: March 4, 2011

EU: Broad Support for IVDD Revisions

Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate strong support for adopting a risk-based classification for in vitro diagnostic devices (IVDs).

Among 116 manufacturers, notified bodies and other medical device industry stakeholders that provided comment, 93% of respondents saw the adoption of risk-based IVD classification based on the Global Harmonization Task Force (GHTF) model as a positive development, allowing for greater flexibility, stronger public health protections and timely market access for new products.

The cost of such a reclassification, however, was also highlighted by some respondents. Specifically, classification according to GHTF standards would necessitate greater regulatory involvement to handle conformity assessment procedures. In turn, manufacturing costs would increase, ultimately driving up prices for end users as well.

Nonetheless, respondents noted that additional costs would likely be offset by improved public health protections, and suggested a five-year transitional period for manufacturers to adjust to the new risk-based classification and its ensuing requirements. In addition, a risk-based IVD classification incorporating the GHTF model would boost European exports, some participants stated, but only if such classification were based on that model—otherwise, additional regulatory costs would not be offset by any financial benefits.

At this point, the EU Commission may discuss and consider these comments and then provide a draft which will likely include GHTF classification rules.

If EU regulators end up adopting these classification rules, Europe will become the second major market after Australia to implement GTHF risk-based classification rules for IVDs.