Medical Innovation Exchange

RC – EU MDR and IVDR

European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance  

European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance       On January 6, the European Commission adopted a proposal to give more time to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal now needs to be adopted by the European Parliament and the Council. The proposal introduces a …

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Connecting More Patients to Clinical Trials

Connecting More Patients to Clinical Trials     Improving diversity in clinical trials is a top priority in the life sciences industry, and rightly so. One-to-one representation of the population intending to use an investigational therapeutic is not just morally right, but also fundamental to its effectiveness. One of the biggest barriers to trials for underrepresented …

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EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance

EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance     Legacy devices may have more time to come into compliance with EU Medical Device Regulations (MDR). On December 9, the European Commission’s Medical Device Coordination Group (MDCG) issued the “MDCG Position Paper on the application of Article 97 MDR to legacy devices for which …

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Swiss National Council Votes To Accept FDA Approved Medical Devices

Swiss National Council Votes To Accept FDA Approved Medical Devices     On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to accept medical devices with FDA approval. Since 2001, healthcare providers and patients in Switzerland have only had access to medical devices with an EU certificate. Swiss MedTech, …

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The Real Impact of IVDR on Clinical Evidence Requirements

The Real Impact of IVDR on Clinical Evidence Requirements     For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …

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The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR     Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …

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State-of-the-Art: Unpacking MDR’s Evolving Requirements

State-of-the-Art: Unpacking MDR’s Evolving Requirements     The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …

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