746?

UPDATED October 23, 2020 With the MDR deadline approaching, many medical device manufacturers do not know for certain whether their Notified Body (NB) will be designated and when! There is no current list of Notified Bodies seeking designation. However, the European Commission has stated that 44 MDR and 11 IVDR applications have been received. That represents a surprising 86% of current MDD NBs and 50% of IVDD NBs. The organizations on the list below account for more than 80% of […]

Cheerio CE Marking – UK MHRA Adopts New Medical Device Registration Scheme on January 1, 2021

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. Moving forward the UK will 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. The UK, not so […]

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 […]

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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