Co-authored by Carlos Galamba, RQM+ Vice President, IVD Intelligence and Innovation and Nancy Morrison, RQM+ Executive Director, Regulatory & Consulting Services 2021 was another big year in the European regulatory realm as EU MDR and IVDR implementation continued to roll out. Let’s take a look at the highlights and lessons learned that we can apply as we go into 2022.
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— coauthored by Amie Smirthwaite, BEng, Ph.D., SVP, Intelligence & Innovation and Carlos Galamba, BSc, MSc, VP, Intelligence & Innovation - IVD With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of assessments are a relatively new concept in the regulatory realm.
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About this article: Could there be more scope for use of equivalence data under EU MDR than you may have thought? Dr. Amie Smirthwaite, Sr. VP of Global Intelligence & Innovation at RQM+, EU MDR expert, thought leader, and member of the working groups that authored MDCG 2020-5 and 2020-6, has put a lot of thought into MDR Article 61 and the associated requirements around equivalence and sufficient clinical evidence. From the early days of implementing the MDR at BSI until now, five years later, supporting the industry in a consultancy role, Amie has found the wording of this article to be puzzling, creating unnecessary challenges for both notified bodies and manufacturers. Amie and the RQM+ team hope that the position taken in this blog will be food for thought for the European Commission, competent authorities and notified bodies, allowing a bit more flexibility for certifying devices that offer a real benefit to patients.
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Quality Management System | post market surveillance
Integrating Post-Market Surveillance Into Your QMS
Now that medical device manufacturers have begun to implement MDR-compliant post-market surveillance (PMS) systems, it is a good time to take stock of common areas of difficulty and inefficiency, and consider how best to address these. Even manufacturers who are continuing to place their devices under extended MDD certification have been required to comply with MDR post-market requirements since May this year.
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