Module 19 2021

01/06/2021

How can we drive harmonisation?

Identify opportunities to participate in working groups e.g. IMDRF, AHWP. Join standards committees ● standards can be too flexible or unclear in expectations, or do not meet a specific need, either for the market or regulators ● some standards do not sufficiently contemplate conformity assessment testing needs. ● ISO and CLSI are major standards organisations relevant to IVDs.

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How can we drive harmonisation?

industry experts are effective in influencing (regulators and therefore) harmonisation efforts when: ● they bring both hard and soft skills to the table. (Your knowledge/experience of manufacturing realities is unique; your credibility is what will be effective.) ● they see these working groups as an opportunity to build trust (we are in it together) ● it is apparent that the patient remains the prime consideration.

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