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.
At long last China’s CFDA is moving on exemption of IVDs from in China trials with publication of a first list of Class II diagnostics proposed for approval without in-China clinical data.
The new MDR is a long document, with interminable preambles and no quick way to get to the key Annexes.
So to help we have extracted the two key Annexes on Classification and Safety and Performance Requirements (Replacement for the Essential Requirements) into tow handy PDF documents.
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 How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world?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?
European Parliament today adopted the MDR, IVDR – setting up a publication within the month and a transitional period ending May 2020 for full implementation of the new regulations.
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