Latest MDR Guidances: Vital Clinical Evidence Documents And Timely Ventilator Requirements
Clinical evidence requirements are much tighter under the EU Medical Device Regulation. Now there is help in addressing these requirements as April sees the publication of a flood of seven guidance documents in total intended to help manufacturers comply with the MDR.
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The European Commission has admitted that MDR implementation has been severely compromised by COVID-19, and potential delays in notified body conformity assessment of products must be addressed to avoid device shortages for patients.
Virtual notified body audits of medtech manufacturers are already taking place through necessity. Now there is guidance concerning if, when, where and how these audits should be carried out.
Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?