There’s much uncertainty and concern about the new IVD Regulation in Europe. The new regulations began this past European holiday weekend, and begin a lengthy transition to implementation. If you are wondering how this may work out, look Down Under, where at the end of June, Australia will complete its transition to new IVD Regulations (IVDR). We take a look at the lessons to learn from the Australian experience.
The European Medical Device and Active Implantable Medical Device Directives have for more than 20 years provided the “best practice” regulatory model which has been adapted into so many other markets around the world. But now Europe has changed. How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world? Is this new global disharmony a threat – or can others follow Europe’s lead and take the opportunity to deliver a more harmonised global regulation?
The Australian Senate Community Affairs Committee has recommended that parliament pass amendments to the Therapeutic Goods Act to implement reforms arising from the Sansom review.
The amendments pave the way for some key changes including introduction of Australian Conformity Assessment Bodies
Last week, the Australian Therapeutic Goods Administration (TGA) published the final guidelines on Clinical Evidence for devices. The guidelines reiterate key elements of clinical evaluation that are often missing from Clinical Evidence Reports. The guidelines also provide specific requirements for certain high risk devices.
TGA has recently released its five new Declaration of Conformity templates specifically for IVDs. In this article we outline which template should be used depending on the conformity assessment route taken and the classification of the IVD.
Over the course of 2016, we’ve been inundated with information around the introduction of the Medical Device Regulation (MDR) in Europe, new revision of ISO 13485, Brexit, and the implementation of MDSAP. Australia has continued to work under the existing arrangements, which rely heavily on recognition of CE certificates granted under the current Medical Device Directives, but how long can this last? The Australian Therapeutic Goods Administration TGA publishes annual statistics of performance. These provide a fascinating insight into the agency’s workload and the extent of reliance on European certification. How will TGA manage in the face of the big changes in Europe?