Module 18 2021

2/9/2021

Annex X / Annex 7 / Article 61 clinical evaluation requirements…

• By default, clinical investigations are required for Class III and implantable • By default, PMS shall include PMCF • The clinical evaluation and its documentation must be regularly updated with PMS data.

MDD/AIMDD: “unless duly justified to rely on existing clinical data” MDR: it’s a bit more complicated, including caveats for equivalence, legacy devices and specific exempted devices…

If not deemed necessary, “must be duly justified and documented”

MedDev 2.7/1 rev 4 (Clause 6.2.3) provides guidance on frequency of updates.

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Analysis of data: “sufficient clinical evidence”

• How much data is enough data?

Risk classifications

• animal tissues, medicinal substances

• invasive, longer term use, high risk anatomical locations, etc

• invasive, longer term use, high risk

• invasive, short term use, relatively low-risk

• non-invasive,

low-risk devices

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