What’s the Difference Between Medical Device Clinical Evaluation and Clinical Performance? We’re Glad You Asked…
What├óΓé¼Γäós the Difference Between Medical Device Clinical Evaluation and Clinical Performance? We├óΓé¼Γäóre Glad You Asked├óΓé¼┬ª In case you need any convincing that many forms of clinical data are a priority for European regulators and Notified Bodies, consider these numbers. The EU Medical Devices Directive (93/42/EEC) mentions the word clinical├é┬á81├é┬átimes. The MDD’s replacement, the EU Medical […]
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Definitive Guide to Medical Device Clinical Evaluation Reports (CER) and EU MDR Requirements
Does Your Medical Device CER Meet EU MDR Requirements? Creating a Solid Clinical Evaluation Process In this guide: Stages in the clinical evaluation processDefining the scope and drafting a plan Making sure CER evaluators are qualifiedCreating a literature review protocolIdentifying data needed to fulfill plan requirementsCrafting a literature search and review strategyChoosing the appropriate dataIs […]
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Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR
Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe├óΓé¼Γäós new In Vitro Diagnostic Regulation (IVDR 2017/746) will impose strict new requirements on many IVD manufacturers […]
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Tips for Updating Clinical Evaluation Reports (CER) and MEDDEV 2.7/1 rev 4
Tips for Updating Clinical Evaluation Reports (CER) and MEDDEV 2.7/1 rev 4 As many veteran QA/RA professionals are painfully aware, the days of a 10-page Clinical Evaluation Report (CER) are a blissful memory of a bygone era. Today├óΓé¼Γäós medical device CERs are now substantial in content, dynamic through the entire life cycle of a product, […]
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Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR
Class 1 Medical Device Manufacturers Must Meet These EU MDR Requirements Right Now You may have read that the transition deadlines for the European Medical Device Regulation (2017/745 MDR) has been extended to 2028. That├óΓé¼Γäós true. But what many Class 1 device manufacturers do not realize is that they still need to comply with certain […]
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State of the Art in the EU MDR: What Does That Actually Mean?
State of the Art in the EU MDR: What Does That Actually Mean? Confused? It├óΓé¼Γäós understandable. Most of us think of state of the art as describing the latest and most advanced stage of a technology. For example, most people would consider a bionic eye to be state of the art. Yet, this notion of […]
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