EU MDR CER and EU IVDR PER for Software:
Understanding MDCG 2020-1

The EU Medical Device Regulation (MDR 2017/745) and EU In Vitro Diagnostic Regulation (IVDR 2017/746) put forward a multitude of challenges, chief among them the process of clinical evaluation. For medical device and IVD companies making products that incorporate software, the question of how much clinical evidence to gather can be perplexing. Rest assured that you are not the only one scratching your head. Many are apprehensive about how Notified Bodies will evaluate clinical evaluation reports (CER) or IVD performance […]

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IVD Performance Evaluation Planning and Report (PER) Requirements in the IVDR 2017/746

Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. That’s about to change in a big way. Starting in May 2022 Europe’s In Vitro Diagnostic Regulation (IVDR 2017/746) will impose strict new requirements on many IVD manufacturers seeking CE Marking for their devices.  Going forward 85-90% of all IVDs seeking CE Marking certification in Europe will need to have their quality management system and technical documentation […]

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MDCG 2020-5 Gives Unequivocal Guidance on Medical Device Equivalence Under the EU MDR

If your medical device clinical evaluation relies on a comparison to an “equivalent” device, you may be wondering if your Notified Body would view your analysis as a true “apples to apples” comparison. Although the word “equivalent” seems clear, few words have created more angst in the context of EU Medical Device Regulation (EU MDR). What exactly does “equivalent” mean? Does it mean “exactly the same” or more like “very similar”? The answer depends on whom you ask. But before […]

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Understanding EU MDR Clinical Evidence Required for “Legacy” Medical Devices as Outlined in MDCG 2020-6

Ever since the release of MEDDEV 2.7-1 rev 4 in 2016 and the publication of the European Medical Device Regulation (EU MDR) in 2017, manufacturers have been coming to grips with the realization that their existing clinical data was not going to cut it in the new EU MDR paradigm. As existing Medical Device Directive (MDD) certificates begin to expire, many manufacturers of legacy medical devices are understandably nervous about how their existing clinical evidence (clinical data + clinical evaluation […]

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