This Q&A document answers questions on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR.
More The European Commission has published a flowchart helping relevant actors to determine the eligibility, conditions, and deadlines for the placing on the market of certain devices referred to in Article 120 MDR as amended by Regulation 2023/607.
More A survey on certifications and applications of MDR-IVDR was conducted in April 2023. The result of the survey is published.
More Due to Regulation (EU) 2023/607, the transition period is extended. Some timelines of the related factsheet or guidance are modified accordingly.
More The Therapeutic Goods Administration (TGA) created a plan to help Australian medical device sponsors and stakeholders transition to the new EU Medical Device Regulation (MDR). The EU then extended the transition period, so the TGA reviewed its original plan. An updated strategy guideline has been published by the TGA regarding the transition and reclassification of certain medical devices.
More This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.
More This guidance aims to provide a clear understanding of what changes to design or intended purpose would be considered 'significant'. It also provides several flowcharts in order to facilitate a harmonised judgement of the significance of a change.
More TGA offers an online publication service to provide market notifications to healthcare providers and/or end users as a result of the EU MDR Transition.
If ALL 6 of the eligibility criteria for streamlined market notifications are met, then the Online Notification Form is to be submitted.
For changes that do not meet ALL six criteria, the new recall notification(s) under TGA compliance will need to be followed.
Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amends the MDR and the IVDR as regards to the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
More This guidance addresses the classification of IVDs and provides clarification rules as set out under Annex VIII of the IVDR.
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