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 EU MDR paradigm. Because many manufacturers of legacy medical devices were understandably nervous about how their existing clinical evidence (clinical data + clinical evaluation results) might be viewed during an upcoming MDR Notified Body […]

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What Notified Bodies Look for When Reviewing Your Medical Device Technical Documentation Under the EU MDR

If you’ve been involved in medical device regulatory affairs for 5+ years, you know all too well that the requirements around technical documentation associated with European CE Marking have tightened. The  MEDDEV 2.7-1 rev 4 guidance on clinical evaluations – in addition to the MDR and updates ISO 14971 risk management standard – gave many regulatory professionals heartburn. Why the deluge? Here’s one factor. About 10 years ago, the French PIP breast implant scandal rocked the Notified Body world and […]

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The EU MDR Has Been Pushed Out to 2021. That’s a Golden Opportunity…

Some will yawn, some will sigh in relief, and some will express frustration that their mad dash to become compliant with the EU Medical Device Regulation (2017/745) deadline was for naught. But few can deny that in light of COVID-19, delaying the start date of the EU MDR from May 2020 until May 2021 was the right call by EU regulators. (FYI, the IVDR date of application remains unchanged as of January 2021.) Regardless of whether you have played the […]

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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 […]

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