News about GMP/cGMP

29.07.2019

MDR/IVDR: Australian TGA keeps tabs on shortage of European NBs

The TGA (Australian Therapeutic Goods Administration) has expressed concern about a looming shortage of Notified Bodies under the new Medical Device and In Vitro Diagnostics Regulations (MDR/IVDR) in Europe. Not without reason, though.

On July 26, 2019 the TGA has released a Version V1.3 of its guidance “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)”. Overseas evidence that can be considered now list EU ISO 13485:2016 certificates and gives further clarification on their acceptability:

  • Certificates issued by Notified Bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union
  • ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022)
  • ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022).

According to TGA, the agency will keep a close eye on the readiness and availability of Notified Bodies in Europe and will consider further amendments in Australia, if necessary.


Source:

TGA: News room



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