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. Europe’s new 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 approved by a […]

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EU MDR and IVDR Guidance Documents:
A Complete List (Including PDF Download Links)

Last Update: July 15, 2022 Shown below is a list of EU guidance documents endorsed by the Medical Device Coordination Group (MDCG). These documents are the ones we believe are most relevant to the majority of medical device and IVD manufacturers. To keep the list manageable, we have excluded guidance that is device-specific, COVID-specific, intended for Notified Bodies, or deemed minor/esoteric. You can (and should) view the entire guidance list here, but first scan the user-friendly version below. NEW! Released […]

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Medical Device Registration under UK MHRA: UKCA Marking Requirements, UK Responsible Person, and More

If you have worked in European regulatory affairs for some time, it’s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. The UK will once again forge its own path, interacting with its continental neighbors in a manner similar to Norway. Yet the key difference is that Norway has chosen to emulate the EU Medical Device Regulation (2017/745) as national law and require CE Marking. In late 2020 the […]

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