This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices
More 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 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 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.
Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.
More The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.
More Most medical devices included in the Australian Register of Therapeutic Goods (ARTG) are supported by an obtained EU MDD certification and may need to transition to the new EU MDR in order to continue to be supplied in Australia.
Yet, many manufacturers are currently dealing with challenges regarding the switch from the EU MDD to the EU MDR. This includes additional requirements for the quality management systems (QMS) of the manufacturer, requiring higher standards in the clinical report to support the patient safety when using the medical device, classification rules changes, and other detailed technical document requirements.
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