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 […]

» Read more

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 […]

» Read more

2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations

Since the release of the European Medical Device Regulation and MEDDEV 2.7/1 Rev 4, medical device regulatory professionals are craving clarity on issues related to clinical data that supports new global submissions and ongoing regulatory compliance. Late in 2019, the International Medical Device Regulators Forum (IMDRF) issued three updated guidance documents that clear up confusion and harmonize the guidance with the EU MDR. They include: Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Evaluation – IMDRF MDCE WG/N56FINAL:2019 (formerly […]

» Read more

What’s the Difference Between Medical Device Clinical Evaluation and Clinical Performance? We’re Glad You Asked…

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 81 times. The MDD’s replacement, the EU Medical Device Regulation (MDR 2017/745), mentions it 677 times. Yes, I know what you’re thinking – the MDR is 3x longer than the MDD – but simple math instantly tells you that the days of scant clinical evaluation reports […]

» Read more
1 2 3