The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices.
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January 5, 2021 Medical Devices, Regulatory Affairs -
December 21, 2020 Medical Devices, Regulatory AffairsAs the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance.
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September 21, 2020 Medical DevicesMedical device industry is witnessing rapid Regulatory reforms, thanks to evolving technologies and scientific developments. In this rapid development scenario, to aid medical device manufacturers, notified bodies, and other stakeholders align with the sophistication and globalization, Regulatory bodies are parallelly revamping the compliance standards.
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June 16, 2020 Medical Devices, Regulatory AffairsClinical investigations are fundamental to medical devices for safety & performance assessments during Regulatory submissions. Emphasizing the significance of how safety reporting in clinical investigations of medical devices should be performed, the European Commission’s Medical Device Coordination Group (MDCG) devised new guidance under Medical Devices Regulation (MDR).
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May 22, 2020 Medical Devices, Regulatory AffairsIn the light of the international health crisis, on April 17, 2020, the European Commission (EC) proposed a one-year delay in the adoption of the new European Union Medical Device Regulations (EU MDR). Originally, the set of regulations were supposed to come into force by May 26, 2020.
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February 28, 2020 Regulatory Artwork Services, Medical Devices, Regulatory Labeling, Regulatory AffairsTo ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the transition period for medical device manufacturers will come to an end from May 26th, 2021, organizations must relook at implementing compliant processes and procedures accordingly.
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December 24, 2019 Medical Devices, Regulatory AffairsAs part of the EU’s Medical Devices Regulation (MDR), the Council of the European Union (EU) has again published a new Corrigendum and a set of corrections. The new corrigendum gives manufacturers of certain Class I devices an additional four years for transition and compliance.
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March 11, 2019 Medical DevicesAustralia’s Therapeutic Goods Administration (TGA) published a consultation paper on 11th February 2019 to receive effective feedback from the industry regarding the proposal of reclassifying spinal implantable medical devices to a higher level of classification.
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January 7, 2019 Pharmaceutical, Medical Devices, Food and Food Supplements, Regulatory AffairsWith each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements.
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June 1, 2018 Medical DevicesOn April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.