Eurolab News

Eurolab Begins Offering Risk Assessment Services Under EU MDR and IVDR Frameworks

Eurolab Begins Offering Risk Assessment Services Under EU MDR and IVDR Frameworks

Jul. 09 2025

Eurolab Begins Offering Risk Assessment Services Under EU MDR and IVDR Frameworks

August 2024 – Istanbul, Türkiye


In response to the evolving regulatory landscape in the medical device sector, Eurolab now offers comprehensive risk assessment services aligned with the European Union Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

These services include full support in the identification of risks, preparation of risk management files, analysis of residual risks, and integration of findings into technical documentation required for CE marking.

Eurolab's regulatory affairs specialists collaborate closely with manufacturers to ensure that all post-market surveillance, clinical evaluation, and risk-benefit analyses are appropriately documented in line with ISO 14971 and EU guidelines.

This development strengthens Eurolab’s position as a trusted partner for companies seeking to maintain EU market access under the stricter post-2021 compliance requirements.

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