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RQM+ Medical Device and In Vitro Diagnostic Blog
Posts By: Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
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Join Live Webinar: Decoding MDCG 2023-7 for MedTech Devices
on 12 February 2024 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
Published in December last year, MDCG 2023-7 clarifies when clinical investigations are not mandatory for Class III and implantable devices. MDCG 2023-7 also shares updated guidelines for when data from equivalent devices may be used in a clinical evaluation under the EU Medical...
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Unveiling MDCG 2023-7: Equivalence, Clinical Investigations and Data Access Under EU MDR
on 21 December 2023 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
Introduction to the New MDCG Guidance A new MDCG guidance document has been published today, providing welcome clarification regarding the practical application of EU MDR Articles 61(4) – (6). This new guidance, "MDCG 2023-7: Guidance on exemptions from the requirement to...
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Don't Get Caught Off Guard: How to Meet the EU's 2024 MDR Deadlines
on 30 August 2023 | By Amie Smirthwaite, Ph.D., RQM+ Senior VP of Intelligence & Innovation and Jaishankar Kutty, Ph.D., RQM+ VP of Intelligence & Innovation
To begin, a cautionary statement... The MDR transition timeline extension is not automatically applied to every legacy device! The timeline extension is conditional in nature, and there are a few key requirements that must be satisfied before manufacturers can benefit from this...
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Risk Management Challenges with IVDR Compliance - This May Be Your Biggest Obstacle
on 13 April 2022 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
IVD manufacturers have had to make significant improvements to their risk files since the days of IVDD. What was once the reality—static and often incomplete files that hardly changed after being placed on the market—is no longer acceptable. However, despite making major headway...
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Europe: 2021 Year-End Review & Looking Ahead to 2022
on 21 February 2022 | By Amie Smirthwaite BEng, PhD, RQM+ Senior Vice President, Intelligence & Innovation; Nancy Morrison, RQM+ Vice President, Intelligence & Innovation
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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MDR and IVDR Mock Technical Assessments and Design Examinations
on 10 January 2022 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
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...
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EU MDR Article 61 and equivalence – is there a new way forward?
on 20 December 2021 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
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, and member of the working groups that authored MDCG 2020-5 and 2020-6, has...
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Integrating Post-Market Surveillance Into Your QMS
on 12 October 2021 | By Amie Smirthwaite BEng, PhD, FRAPS, RQM+ Senior Vice President, Intelligence & Innovation
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...
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