Australia Reacts to Potential Notified Body Shortages
Posted 26 July 2019 | By
Australia’s Therapeutic Goods Administration (TGA) on Friday warned of a shortage of notified bodies under the EU’s medical device and in vitro
diagnostics regulations (MDR/IVDR) and expanded the scope of what it considers to be acceptable overseas evidence for marketing authorizations.
“TGA is aware of industry concern should a sufficient number of notified bodies not have been designated” by MDR’s 26 May 2020 application. “This may impact manufacturers seeking certification for new products, and may also have impacts for maintaining existing certification, particularly where European notified choose not to transition to the new regulations,” TGA says.
Industry has continued to raise concerns relating to the readiness and availability of notified bodies during the transition as only two notified bodies—BSI UK and TÜV SÜD—have been designated against MDR so far and several have recently indicated they do not intend to apply.
TGA says it’s “monitoring the situation and if there are any significant changes to the current EU transitional arrangements prescribed” in MDR/IVDR, “we will consider whether any flow on amendments may be required in Australia.”
The agency’s notice on MDR/IVDR implications for Australia coincides with its guidance on acceptable overseas evidence in the touted use of its process for accepting other regulators’ decisions. “These comparable overseas regulator arrangements may provide alternative pathways if delays arise in obtaining or maintaining European conformity assessment evidence,” the regulator said.
TGA released on Friday the third edition of its guidance on how manufacturers of medical devices and IVDs can use evidence of market authorizations from comparable overseas regulators and assessment bodies, following the entry into force of the Therapeutic Goods Amendment Determination 2019
in April. Previous versions indicated
13485 certificates issued by a certification body accredited by a signatory member of the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MRA) would not be accepted.
But the latest version of the guidance shows the agency has begun accepting 13485:2016 certificates issued by a certification body accredited by an IAF MRA signatory member in 90 jurisdictions. TGA’s pivot on allowing the use of such certificates underscores the intent of the 2016 revisions—to encourage further harmonization across regulators and assessment bodies. TGA audits conducted against 13485:2016 began at the beginning of January, following the end
of the three-year transition to the quality management systems global standard.
Version 1.3 also links to the legislative instruments that take precedence over the agency’s guidance. The agency notes that “in case of any inconsistencies between instruments (including future amendments) and this guidance, the instruments are in force and should be followed.”
With their entry into force in April, the legislative instruments establish the acceptable overseas regulators
as well as the information required to include in applications
. The expanded scope of TGA’s guidance covers seven that are now considered an overseas regulator. Acceptable evidence can be used as part of applications for inclusion in the Australian Register of Therapeutic Goods (ARTG) too.
The guidance explains what documentation is required from an IAF accredited conformity assessment body, a notified body under the EU’s directives and new regulations (MDR/IVDR), a Medical Device Single Audit Program auditing organization, Health Canada, Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency and the US Food and Drug Administration.
For IVD inclusion applications, TGA will only accept 13485:2016 certificates issued by a notified body or an IAF MLA accredited assessment body until IVDR’s 26 May 2022 date of application.
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)