Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer
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Risk Management and Other Cybersecurity Considerations for Connected Medical Devices
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Preparing for MDR: Don’t Forget about Class I Reusable Devices
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Patent and Regulatory Challenges in AI’s Use in Life Sciences
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EU MDR Post-Market Surveillance: Active, Integrated, Risk-Based, and Planned
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EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation
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Full Economic Impact of COVID-19 on Life Sciences Industry Still Uncertain
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The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device…
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EU MDR has increased the regulatory burden for medical device companies, but it can also serve as a catalyst for innovation and an opportunity to streamline clinical evaluation workflows through the adoption of digitalization and AI-powered automation.
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On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
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Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with…
