Medical Devices

Preliminary Assessment Review (PAR) and Preliminary Re-assessment Review (PRAR) Form Template for EU MDR and IVDR published

Several MDCG guidance documents have been published on the Commission website (MDCG 2024-6, MDCG 2024-7, MDCG 2024-8, MDCG 2024-9). These concern the Preliminary assessment review (PAR) and Preliminary re-assessment review (PRAR) form templates for the EU MDR and IVDR.

Preliminary Assessment Review (PAR) and Preliminary Re-assessment Review (PRAR) Form Template for EU MDR and IVDR published
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