Dive Brief:

• Australia's Therapeutic Goods Administration (TGA) on Friday said it is aware of industry concern about whether a sufficient number of notified bodies will be designated under the new European Union Medical Device Regulation in time for the May 2020 effective date.
• The Australian regulator said it is monitoring the situation and will consider the impact on manufacturers seeking certification for new products or looking to maintain existing certification.
• The agency also said it has expanded the range of assessments and approvals from overseas regulators that medical device makers can use when submitting applications for inclusion in the Australian Register of Therapeutic Goods.

Dive Insight:

The Australian regulator said it developed guidance providing an overview on the use of specific overseas assessments and approvals for device makers seeking marketing authorization. The guide covers use of market authorization evidence from comparable overseas device regulators as well as a question-and-answer section for applicants with examples of when TGA will conduct an application audit.

Medical device manufacturers have until May 26, 2020, to complete product recertification to continue European sales. Notified bodies are in the process of being reaccredited for the new medical device rules, raising concerns about whether there will be enough agencies to perform conformity assessments for CE marking for thousands of devices.

The TGA said many sponsors of medical devices and in vitro diagnostic (IVD) devices use conformity assessment certifications issued by European notified bodies to support applications for marketing authorization in Australia. The EU in vitro diagnostics regulation becomes effective May 26, 2022, following a five-year transition period. During the transitional periods for devices and diagnostics, certification that remains valid in Europe may also be used in Australia, TGA said.

Notified bodies are organizations designated by an EU country to assess products before they can be marketed in the EU. U.K. notified bodies Lloyd's Register Quality Assurance and UL International and Swiss notified body QS Zürich have all announced plans to withdraw notified body services from the medtech sector, just as the industry prepares for a regulatory overhaul designed to tighten controls for product safety and performance after problems with breast implants and metal hip replacement devices damaged confidence in the system of oversight.

Australia's comparable overseas regulators and assessment bodies include notified bodies of European member states, FDA, Health Canada, the Medical Device Single Audit Program (MDSAP) Auditing Organization, and the Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency of Japan.