There’s been a lot of focus on the process for re-designation of Notified Bodies in Europe – so that we can all start the process of certification to the new Medical Device and IVD regulations. But what happens if your Notified Body fails to achieve re-designation, or has its scope narrowed – or just gives up and goes away?
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 How will other markets deal with the regulatory disconnect between the new European Model and the now outdated copies around the world?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?
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?
The European Union finally agreed late Wednesday Brussels time on a final text for the long awaited European Device regulations. Agreement of course is subject to approval by other players in the EU political process, but it does look as though we are reaching the end of the journey in the long awaited updates to the MDD/AIMD/IVDD Directives. The long telegraphed increases in rigour of inspection, post market monitoring and unannounced inspections are all included.