Month: December 2022

MDCG Position on Hybrid Audits

The EU’s Medical Device Coordination Group (MDCG) have outlined their opinion on the practice of hybrid audits by Notified Bodies in their position paper MDCG 2022-17. Hybrid audits, in which Notified Bodies would assess part of a manufacturer’s compliance over an online conference call, became popular during the COVID-19 pandemic which limited travel as well …

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Reclassification of Certain Active Products without a Medical Intended Purpose

On 2 December 2022, Commission Implementing Regulation (EU) 2022/2347 on the “reclassification of groups of certain active products without an intended medical purpose” was published in the Official Journal of the European Union (OJEU). This concise bit of legislation may have a dramatic impact on the conformity assessment of Annex XVI products under the EU …

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