Australia – Consultation: Proposed changes to IVD medical device classifications and definitions
In-vitro diagnostic (IVD) medical devices are regulated in Australia by the Therapeutic Goods Administration (TGA) having regard to the risks (to the individual or...
Europe – MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class...
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the requirements for sampling of...
Europe – Interface between the Regulations on clinical trials of medicinal products, medical devices...
In the EU, there are legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and...
Europe – Commission launches a public consultation and a call for evidence for EU...
The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as...
UK – Medical Devices Regulatory Reform – Roadmap to implementation – Update
A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition...
Europe – MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of...
The Medical Device Coordination Group (MDCG) has introduced new guidance under MDCG 2024-16, streamlining how manufacturers report interruptions or discontinuations in the supply of...
Australia – How to submit a custom-made medical device / patient-matched medical device notification...
The following guide is designed to assist you with completing and submitting a:
• Custom-Made Medical Device (CMMD) notification; and
• Patient-Matched Medical Device (PMMD) transition...
Australia – Understanding personalised medical devices rules (including 3D-printed devices) – Regulatory changes for...
Personalised medical devices are devices that are either designed and manufactured, or modified after they are supplied, to suit an individual.
This document provides information...
Australia – Refinements to the Personalised Medical Device Framework
The public consultation indicated the importance of the TGA’s role as the regulator of
medical devices, affirming that in the majority of cases medical devices...
China- Medical Device Administrative Control System (MDACS)
During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device...
