Latest EU MDR and IVDR Updates and Developments

The countdown continues toward the EU MDR (May 2021) and IVDR (May 2022) implementation deadlines. Following are a series of articles covering key EU MDR and IVDR topics.  Check back often for up to date news on which Notified Bodies have been designated, UDI, the European Commission implementation plan, timelines, and more.   European Commission Opens Door to Remote Notified Body Audits…For Now January 13, 2021 Finally acknowledging that COVID is not going away anytime soon, and the EU MDR […]

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

Last Update: January 11, 2021 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 medical device and IVD manufacturers. To keep the list manageable, we have excluded guidance that is device-specific, intended for Notified Bodies, or deemed very minor/esoteric. As you can see, not much has been published lately (most likely due to COVID), which is more than a little concerning […]

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